NDC 76420-504

Zylotrol

Lidocaine 4%, Menthol 4%

Zylotrol is a Topical Patch in the Human Otc Drug category. It is labeled and distributed by Asclemed Usa, Inc.. The primary component is Lidocaine; Menthol, Unspecified Form.

Product ID76420-504_ead97aa4-5942-b457-e053-2a95a90a46f1
NDC76420-504
Product TypeHuman Otc Drug
Proprietary NameZylotrol
Generic NameLidocaine 4%, Menthol 4%
Dosage FormPatch
Route of AdministrationTOPICAL
Marketing Start Date2022-09-26
Marketing CategoryOTC MONOGRAPH NOT FINAL /
Application Numberpart348
Labeler NameAsclemed USA, Inc.
Substance NameLIDOCAINE; MENTHOL, UNSPECIFIED FORM
Active Ingredient Strength4 g/100g; g/100g
Pharm ClassesAmide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 76420-504-15

15 PATCH in 1 BOX (76420-504-15) > 4 g in 1 PATCH
Marketing Start Date2022-10-12
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Zylotrol" or generic name "Lidocaine 4%, Menthol 4%"

NDCBrand NameGeneric Name
76420-145ZylotrolLidocaine HCl 4%, Menthol 1%
76420-504ZylotrolLidocaine 4%, Menthol 4%
81902-130ZylotrolLidocaine 4%, Menthol 4%
81902-201ZylotrolLidocaine HCl 4%, Menthol 1%

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