[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-lydia-co-ltd-659646-06262023":3,"fda-latest-sync-dates":31},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":13,"case_status":14,"letter_url":15,"reference_number":16,"marcs_cms_no":17,"product_type":18,"delivery_method":8,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":29,"updated_at":30},2018,"lydia-co-ltd-659646-06262023","Warning Letter","Lydia Co. Ltd.",null,"Center for Drug Evaluation and Research | CDER","Failure to Register and List","2023-07-04","2023-06-26","2023-08-23","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flydia-co-ltd-659646-06262023","WL - 2575","659646","Drugs","Ho Dong Yang","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n      \n              \u003Cdt class=\"cell-1_2\">Reference #:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_2\">WL - 2575\u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Ho Dong Yang\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Lydia Co. Ltd.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">102 Dongguk-ro\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"dependent-locality\">Ilsandong-gu\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Goyang-si\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"administrative-area\">Gyeonggi-do\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"postal-code\">10325\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">South Korea\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:onbix@naver.com\"> onbix@naver.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research | CDER\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\" data-a11y-ignore=\"pNotUsedAsHeader\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>June 26, 2023\u003C\u002Fp>\n\n\u003Cp>RE: WL - 2575\u003C\u002Fp>\n\n\u003Cp>Dear Ho Dong Yang:\u003C\u002Fp>\n\n\u003Cp>The United States Food and Drug Administration (FDA) has reviewed your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug products, Hot Pap Cataplasma (NDC 72988-0007), Amuldy Sports Gel (NDC 72988-0023), Zenol Cool (NDC 72988-0026), Antiphlamine (NDC 72988-0028), Mentholatum (NDC 72988-0031), New Hanbang Col Cap (NDC 72988- 0032), Nocold-S (NDC 72988-0033), and Albothyl (NDC 72988-0035). Our review determined that your firm has submitted contradictory information between the labeling and the electronic listing files. As such, your firm is in violation of the Federal Food, Drug, and in Cosmetic Act (FD&C Act) as explained below.\u003C\u002Fp>\n\n\u003Cp>We refer you to FDA’s drug listing deficiency letter notification dated March 17, 2023, describing the observed listing deficiencies in the information you submitted. We also refer you to FDA’s data removal email notification sent on May 1, 2023, informing you of a data removal action. As stated in this email, the continued deficiencies resulted in your products’ data removal from FDA’s Online NDC Directory.\u003C\u002Fp>\n\n\u003Cp>Section 510(j)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 207 outline the requirements for registration and listing of drug products. In the case of your products’, Hot Pap Cataplasma (NDC 72988-0007), Amuldy Sports Gel (NDC 72988-0023), Zenol Cool (NDC 72988-0026), Antiphlamine (NDC 72988-0028), Mentholatum (NDC 72988-0031), New Hanbang Col Cap (NDC 72988-0032), Nocold-S (NDC 72988-0033), and Albothyl (NDC 72988-0035), there are various discrepancies between the labeling and the electronic listing files. The following table outlines the specific errors found in each listing submission for products.\u003C\u002Fp>\n\n\u003Cp> \u003C\u002Fp>\n\n\u003Ctable class=\"MsoTableGrid\" style=\"border-collapse:collapse; border:none\">\n\t\u003Ctbody>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:1px solid black; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Product name \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">as submitted \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">in the listing \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">file\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:1px solid black; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Product \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">NDC\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:1px solid black; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Error(s) found\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:1px solid black; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Legal citation(s)\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd rowspan=\"2\" style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Hot Pap \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Cataplasma\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd rowspan=\"2\" style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">72988-\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">0007\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">1. The list of active ingredients does \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">not match between the labeling and \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">the electronic listing file. Specifically, \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">while the labeling includes methyl \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">salicylate and vanillyl nonylamide, the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">electronic listing file only includes the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">methyl salicylate.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Under 21 CFR \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">207.49(a)(4), each \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">registrant must provide \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">the name and quantity of each active \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">pharmaceutical \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">ingredient in the listed \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">drug.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">2. There is incomplete package \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">quantity information under the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">packaging section of the electronic \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">listing file. Specifically, while the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">labeling indicates that the total \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">quantity supplied is 5 sheets, with \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">each sheet weighing 13.4 g, the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">packaging section of the electronic \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">listing file, only includes package \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">code of (1) which corresponds to one \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">sheet or a total of 13.4 g. Another \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">package code corresponding to the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">quantity of 5 sheets is not included.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Under 21 CFR 207.49(a)(2), each registrant must provide the package type and volume information corresponding to the package code segment of the NDC.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Amuldy Sports Gel\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">72988-0023\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">1. The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the labeling menthol, methyl salicylate, camphor and salicylic acid,\u003Cbr>\n\t\t\tthe electronic listing file only includes menthol.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Under 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical\u003Cbr>\n\t\t\tingredient in the listed drug.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Zenol Cool\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">72988-\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">0026\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">1. The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the labeling includes menthol, and methyl salicylate, the electronic listing file only includes methyl salicylate.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Under 21 CFR 207.49(a)(4), each\u003Cbr>\n\t\t\tregistrant must provide\u003Cbr>\n\t\t\tthe name and quantity of\u003Cbr>\n\t\t\teach active pharmaceutical ingredient in the listed drug.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Antiphlamine\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">72988-\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">0028\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">1. There is a mismatched dosage \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">form between the labeling and the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">electronic listing file. Specifically, \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">While the labeling includes the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">dosage form as lotion, the electronic \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">listing file includes the dosage form \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">as ointment.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Under 21 CFR \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">207.49(a)(6), each \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">registrant must provide \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">the dosage form for each \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">listed drug.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Mentholatum,\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">72988-\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">0031\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">1. The strength of the active \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">ingredients as expressed in the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">electronic listing file is misleading. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Specifically, while the strength of the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">active ingredients, DL menthol and \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">methyl salicylate in the labeling is \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">expressed in milligrams\u002F gram, the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">strength of these active ingredients in \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">the electronic listing file is expressed \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">in milligrams\u002F milliliter.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Under 21 CFR \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">207.49(a)(4), each \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">registrant must provide \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">the name and the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">quantity of each active \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">pharmaceutical \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">ingredient in the listed \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">drug.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">New Hanbang \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Col Cap\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">72988-\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">0032\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">1.The list of active ingredients does \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">not match between the labeling and \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">the electronic listing file. Specifically, \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">while the Drug Facts section of the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">labeling states, acetaminophen, \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">caffeine anhydrous, chlorpheniramine \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">maleate, and tipepidine hibenzate, \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">the electronic listing file includes only \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">acetaminophen and caffeine.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Under 21 CFR \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">207.49(a)(4), each \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">registrant must provide \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">the name and quantity of \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">each active \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">pharmaceutical \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">ingredient in the listed \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">drug.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd rowspan=\"2\" style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Nocold-S\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd rowspan=\"2\" style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">72988-\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">0033\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">1. The list of active ingredients does \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">not match between the labeling and \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">the electronic listing file. Specifically, \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">while the active ingredients included \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">in the product’s labeling appear to be \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">acetaminophen and \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">chlorpheniramine, the nonproprietary \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">name field in the electronic listing file, \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">includes the active ingredients as \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">acetaminophen and caffeine.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Under 21 CFR \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">207.49(a)(4), each \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">registrant must provide \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">the name and quantity of \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">each active \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">pharmaceutical \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">ingredient in the listed \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">drug.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">2. There is mismatched strength of t\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">he active ingredient, \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">chlorpheniramine, between the labeling and the electronic listing file. Specifically, while the strength in the \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">labeling is 2.5 mg in 20 ml, the strength of chlorpheniramine in the\u003Cbr>\n\t\t\telectronic listing file is included as 200 mg in 20 ml.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Under 21 CFR \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">207.49(a)(4), each \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">registrant must provide \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">the name and quantity of \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">each active \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">pharmaceutical ingredient in the listed drug.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Albothyl\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">72988-\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">0035\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">1. There is mismatched or misleading strength of active ingredient, policresulen, between the labeling and the electronic listing file. Specifically, while the strength, included in the labeling is 720 mg\u002Fg, the strength for policresulen in the electronic listing file is 720 mg in 1 ml.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"line-height:normal\">\u003Cspan style=\"font-family:Calibri,sans-serif\">Under 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of\u003Cbr>\n\t\t\teach active pharmaceutical ingredient in the listed drug.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\u003C\u002Ftbody>\n\u003C\u002Ftable>\n\n\u003Cp>\u003Cbr>\nTherefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, which is a prohibited act under section 301(p), 21 U.S.C. 360(j) and 331(p). In addition, failure to properly list a drug with FDA also renders it misbranded under section 502(o) of the FD&C Act, and in violation of section 301(a) of the FD&C Act, 21 U.S.C. 352(o) and 331(a).\u003C\u002Fp>\n\n\u003Cp>Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.\u003C\u002Fp>\n\n\u003Cp>We note that this warning letter only addresses registration and listing issues associated with your products. It is not intended to be an all-inclusive statement of violations that may exist in connection with your products. Your firm should investigate and determine the causes of any violations and take prompt actions to correct the violations and bring the products into compliance.\u003C\u002Fp>\n\n\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.\u003C\u002Fp>\n\n\u003Cp>Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. In absence of a corrective action, the deficient listing data will not be available for certification under 21 CFR 207.57(b)(2) requirements and will be ultimately inactivated by FDA. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\n\n\u003Cp>Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research\u002FOffice of Compliance\u002FOffice of Unapproved Drugs and Labeling Compliance by e-mail to eDRLS@fda.hhs.gov. Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. If you receive a validation error or have any questions regarding the contents of this letter, please contact us at eDRLS@fda.hhs.gov. for further assistance. Include the case identification number, 2575 on all correspondence.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003Cbr>\nTina Smith\u003C\u002Fp>\n\n\u003Cp>CC: FDA District Office\u003Cbr>\nCC: onbixus@gmail.com\u003Cbr>\nAttn: U.S. Agent\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Reference #:\n\nWL - 2575\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nHo Dong Yang\n\nLydia Co. Ltd.\n\n102 Dongguk-ro\n\nIlsandong-gu\n\nGoyang-si\n\nGyeonggi-do\n\n10325\n\nSouth Korea\n\nonbix@naver.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWARNING LETTER\n\nJune 26, 2023\n\nRE: WL - 2575\n\nDear Ho Dong Yang:\n\nThe United States Food and Drug Administration (FDA) has reviewed your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug products, Hot Pap Cataplasma (NDC 72988-0007), Amuldy Sports Gel (NDC 72988-0023), Zenol Cool (NDC 72988-0026), Antiphlamine (NDC 72988-0028), Mentholatum (NDC 72988-0031), New Hanbang Col Cap (NDC 72988- 0032), Nocold-S (NDC 72988-0033), and Albothyl (NDC 72988-0035). Our review determined that your firm has submitted contradictory information between the labeling and the electronic listing files. As such, your firm is in violation of the Federal Food, Drug, and in Cosmetic Act (FD&C Act) as explained below.\n\nWe refer you to FDA’s drug listing deficiency letter notification dated March 17, 2023, describing the observed listing deficiencies in the information you submitted. We also refer you to FDA’s data removal email notification sent on May 1, 2023, informing you of a data removal action. As stated in this email, the continued deficiencies resulted in your products’ data removal from FDA’s Online NDC Directory.\n\nSection 510(j)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 207 outline the requirements for registration and listing of drug products. In the case of your products’, Hot Pap Cataplasma (NDC 72988-0007), Amuldy Sports Gel (NDC 72988-0023), Zenol Cool (NDC 72988-0026), Antiphlamine (NDC 72988-0028), Mentholatum (NDC 72988-0031), New Hanbang Col Cap (NDC 72988-0032), Nocold-S (NDC 72988-0033), and Albothyl (NDC 72988-0035), there are various discrepancies between the labeling and the electronic listing files. The following table outlines the specific errors found in each listing submission for products.\n\nProduct name as submitted in the listing file\n\nProduct NDC\n\nError(s) found\n\nLegal citation(s)\n\nHot Pap Cataplasma\n\n72988-0007\n\n1. The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the labeling includes methyl salicylate and vanillyl nonylamide, the electronic listing file only includes the methyl salicylate.\n\nUnder 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical ingredient in the listed drug.\n\n2. There is incomplete package quantity information under the packaging section of the electronic listing file. Specifically, while the labeling indicates that the total quantity supplied is 5 sheets, with each sheet weighing 13.4 g, the packaging section of the electronic listing file, only includes package code of (1) which corresponds to one sheet or a total of 13.4 g. Another package code corresponding to the quantity of 5 sheets is not included.\n\nUnder 21 CFR 207.49(a)(2), each registrant must provide the package type and volume information corresponding to the package code segment of the NDC.\n\nAmuldy Sports Gel\n\n72988-0023\n\n1. The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the labeling menthol, methyl salicylate, camphor and salicylic acid,\n\nthe electronic listing file only includes menthol.\n\nUnder 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical\n\ningredient in the listed drug.\n\nZenol Cool\n\n72988-0026\n\n1. The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the labeling includes menthol, and methyl salicylate, the electronic listing file only includes methyl salicylate.\n\nUnder 21 CFR 207.49(a)(4), each\n\nregistrant must provide\n\nthe name and quantity of\n\neach active pharmaceutical ingredient in the listed drug.\n\nAntiphlamine\n\n72988-0028\n\n1. There is a mismatched dosage form between the labeling and the electronic listing file. Specifically, While the labeling includes the dosage form as lotion, the electronic listing file includes the dosage form as ointment.\n\nUnder 21 CFR 207.49(a)(6), each registrant must provide the dosage form for each listed drug.\n\nMentholatum,\n\n72988-0031\n\n1. The strength of the active ingredients as expressed in the electronic listing file is misleading. Specifically, while the strength of the active ingredients, DL menthol and methyl salicylate in the labeling is expressed in milligrams\u002F gram, the strength of these active ingredients in the electronic listing file is expressed in milligrams\u002F milliliter.\n\nUnder 21 CFR 207.49(a)(4), each registrant must provide the name and the quantity of each active pharmaceutical ingredient in the listed drug.\n\nNew Hanbang Col Cap\n\n72988-0032\n\n1.The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the Drug Facts section of the labeling states, acetaminophen, caffeine anhydrous, chlorpheniramine maleate, and tipepidine hibenzate, the electronic listing file includes only acetaminophen and caffeine.\n\nUnder 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical ingredient in the listed drug.\n\nNocold-S\n\n72988-0033\n\n1. The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the active ingredients included in the product’s labeling appear to be acetaminophen and chlorpheniramine, the nonproprietary name field in the electronic listing file, includes the active ingredients as acetaminophen and caffeine.\n\nUnder 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical ingredient in the listed drug.\n\n2. There is mismatched strength of the active ingredient, chlorpheniramine, between the labeling and the electronic listing file. Specifically, while the strength in the labeling is 2.5 mg in 20 ml, the strength of chlorpheniramine in the\n\nelectronic listing file is included as 200 mg in 20 ml.\n\nUnder 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical ingredient in the listed drug.\n\nAlbothyl\n\n72988-0035\n\n1. There is mismatched or misleading strength of active ingredient, policresulen, between the labeling and the electronic listing file. Specifically, while the strength, included in the labeling is 720 mg\u002Fg, the strength for policresulen in the electronic listing file is 720 mg in 1 ml.\n\nUnder 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of\n\neach active pharmaceutical ingredient in the listed drug.\n\nTherefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, which is a prohibited act under section 301(p), 21 U.S.C. 360(j) and 331(p). In addition, failure to properly list a drug with FDA also renders it misbranded under section 502(o) of the FD&C Act, and in violation of section 301(a) of the FD&C Act, 21 U.S.C. 352(o) and 331(a).\n\nComplete, accurate and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.\n\nWe note that this warning letter only addresses registration and listing issues associated with your products. It is not intended to be an all-inclusive statement of violations that may exist in connection with your products. Your firm should investigate and determine the causes of any violations and take prompt actions to correct the violations and bring the products into compliance.\n\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.\n\nPlease notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. In absence of a corrective action, the deficient listing data will not be available for certification under 21 CFR 207.57(b)(2) requirements and will be ultimately inactivated by FDA. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\n\nYour response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research\u002FOffice of Compliance\u002FOffice of Unapproved Drugs and Labeling Compliance by e-mail to eDRLS@fda.hhs.gov. Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. If you receive a validation error or have any questions regarding the contents of this letter, please contact us at eDRLS@fda.hhs.gov. for further assistance. Include the case identification number, 2575 on all correspondence.\n\nSincerely,\n\n\u002FS\u002F\n\nTina Smith\n\nCC: FDA District Office\n\nCC: onbixus@gmail.com\n\nAttn: U.S. Agent","2026-08-20T00:59:30.485+00:00",[24,25,26,9,10,27,28,27],"\u003Ctime datetime=\"2023-07-04T13:20:00Z\">07\u002F04\u002F2023\u003C\u002Ftime>\n","\u003Ctime datetime=\"2023-06-26T04:00:00Z\">06\u002F26\u002F2023\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flydia-co-ltd-659646-06262023\">Lydia Co. Ltd.\u003C\u002Fa>","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flydia-co-ltd-659646-08182023\">\u003Ctime datetime=\"2023-08-23T04:00:00Z\">08\u002F23\u002F2023\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:29.145918+00:00","2026-08-20T02:24:56.344395+00:00",{"510k":32,"classification":33,"enforcement":34,"event":35,"pma":36,"warning_letter":37},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]