Home NDC 49283-577 MENTHOL
Product NDC 49283-577
11-digit product format 492830577
Labeler code 49283
Product ID 49283-577_472fb2a3-fb5f-c07b-e063-6394a90a1c7c
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form GEL
Route TOPICAL
Labeler CHEMCO CORPORATIOM
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-20
Substance MENTHOL, UNSPECIFIED FORM
Active strength 4 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base MENTHOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 4 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49283-577-03 MENTHOL 90 mL in 1 BOTTLE, WITH APPLICATOR GEL 90 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 99 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Anti Itch ANTI ITCH Neilmed Pharmaceuticals Inc. 2fa74baf-e3d2-e099-e063-6394a90a1bae 2025-03-06 Warnings Exact identifier application number: M017 Thunder Fck Male Genital Desensitizer BENZOCAINE PRODUCT MAX GROUP INC 93188a42-0d3c-4159-bdc7-bbc5ec5c6744 2025-03-06 Warnings Exact identifier application number: M017 Body Action Climax Guard Delay BENZOCAINE PRODUCT MAX GROUP INC f88e0b42-974e-4f46-a93b-34b06320770a 2025-03-06 Warnings Exact identifier application number: M017 XENCARE INFLAMAX NATURAL TOPICAL PAIN MENTHOL, CAPSAICIN Xenex Laboratories Inc. 25b9621b-3c16-3cb9-e063-6294a90ab598 2025-03-06 Warnings Exact identifier application number: M017 Pain Relieving Cream CAMPHOR AND MENTHOL PAIN WIZARD LIMITED LIABILITY COMPANY 1cd37b69-2cfb-130d-e063-6394a90af50b 2025-03-06 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Walgreens Co. c22bba5c-bb6f-494e-987a-f6e36c1b4893 2025-03-06 Warnings Exact identifier application number: M017 Redicare Burn Gel REDICARE BURN GEL Redicare LLC 947ac362-acfb-3508-e053-2a95a90a2873 2025-03-05 Warnings Exact identifier application number: M017 Thera Plus Hydrocortisone Maximum Strength HYDROCORTISONE FOURSTAR GROUP USA, INC. c2bc8f0c-38ea-4124-bc51-bf22e6751a92 2025-03-04 Warnings Exact identifier application number: M017 Thera Plus Eczema Hydrocortisone Anti Itch HYDROCORTISONE Fourstar Group USA, Inc. 7c72217b-db9a-4573-9f14-4c11528fa452 2025-03-04 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc. fb89dca6-c0c0-4092-b3f5-e59c956c3d6c 2025-03-04 Warnings Exact identifier application number: M017 Peppermint soothing cream CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOL Henan Lijitang Medical Technology Co., Ltd. 2f6bc332-3006-710d-e063-6394a90acea5 2025-03-03 Warnings Exact identifier application number: M017 Thera Plus Pain Relief Arthritis and Muscle CAPSAICIN FOURSTAR GROUP USA, INC. dcff0a2d-7190-4b0c-abde-ba009b8ef005 2025-02-28 Warnings Exact identifier application number: M017 GoodSense Anti-Itch DIPHENHYDRAMINE HCL, ZINC ACETATE Geiss, Destin & Dunn, Inc 2f38bdfc-6135-1b8a-e063-6294a90a6703 2025-02-28 Warnings Exact identifier application number: M017 Capsaicin 0.05% Cream CAPSAICIN 0.05% Puretek Corporation 2cf17a28-711f-77bd-e063-6394a90a7061 2025-02-28 Warnings Exact identifier application number: M017 Lidocaine Pain-Relief Patches LIDOCAINE PATCH Meijer, Inc 2f247929-6bff-1e59-e063-6394a90acdba 2025-02-27 Warnings Exact identifier application number: M017 Lightning Products BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 555ac696-e761-4a5a-bed8-945dc64d5be5 2025-02-27 Warnings Exact identifier application number: M017 Hydrocortisone with aloe HYDROCORTISONE Encube Ethicals, Inc. 12a1774d-a97e-4787-b6b1-8e8cd40b7b70 2025-02-26 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Feminine Anti-Itch BENZOCAINE, RESORCINOL FOURSTAR GROUP USA, INC. 0007e3ea-882b-4000-8e70-2bcec2c08613 2025-02-26 Warnings Exact identifier application number: M017 Tattoo numbing cream LIDOCAINE BLOOMWELL GARDENS LLC 2ea9d34e-408d-f8d6-e063-6394a90a72a4 2025-02-26 Warnings Exact identifier application number: M017 Icy Hot Pro No-Mess CAMPHOR, MENTHOL Chattem, Inc. 9e8fedf5-fb59-4531-b288-715f851ee05b 2025-02-26 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49283-577-03 49283057703 90 mL in 1 BOTTLE, WITH APPLICATOR (49283-577-03) 90 ml 2025-12-20 No No Current