Home NDC 49283-577-03 MENTHOL
Product NDC 49283-577
Requested package NDC 49283-577-03
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 2027-12-31
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 2027-12-31 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 86 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CVS Cortisone HYDROCORTISONE CVS Pharmacy 87631be8-94b8-4718-858d-d2f30e636cce 2025-07-10 Warnings Exact identifier application number: M017 TopCare Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE Topco Associates LLC c40e8e1d-d6d7-4880-99d3-011b97a5e4f3 2025-07-10 Warnings Exact identifier application number: M017 Live Better Hydrocortisone with Aloe HYDROCORTISONE The Great Atlantic & Pacific Tea Company 044e6ee2-98a6-4802-b33d-78b8551356c4 2025-07-10 Warnings Exact identifier application number: M017 Rocainol TOPICAL ANALGESIC METHYL SALICYLATE, MENTHOL Compania Internacional de Comercio, S.A.P.I de C.V. 827ec7b2-3d87-47e0-a47a-966b25732c32 2025-07-10 Warnings Exact identifier application number: M017 NumbR-X LIDOCAINE HCL Prodigy Media Inc 16329ab6-4a33-4c38-85e0-5aad9c75d61d 2025-07-10 Warnings Exact identifier application number: M017 Dr Lido LIDOCAINE HCL Prodigy Media Inc da0938f0-00e7-4502-8721-d64c71f594fc 2025-07-10 Warnings Exact identifier application number: M017 Pain Relief Patch CAMPHOR, METHYL SALICYLATE, MENTHOL CDMA, Inc. da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b 2025-07-09 Warnings Exact identifier application number: M017 ORTHOGEL Menthol 3.5% MENTHOL LiquidCapsule Manufacturing LLC 4fd4b7ac-1971-4abe-8fbb-74ab69e12061 2025-07-09 Warnings Exact identifier application number: M017 Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE AmerisourceBergen f36acdb8-a526-4bb7-a557-e1dcbbc1cf45 2025-07-08 Warnings Exact identifier application number: M017 Good Neighbor Pharmacy Hydrocortisone with Aloe HYDROCORTISONE AmerisourceBergen 0c544792-63d9-400c-9888-207c44fdc75e 2025-07-08 Warnings Exact identifier application number: M017 Good Neighbor Pharmacy Hydrocortisone HYDROCORTISONE AmerisourceBergen 58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf 2025-07-08 Warnings Exact identifier application number: M017 Publix Hydro HYDROCORTISONE Publix Super Markets Inc 29296b0f-0eed-4bb9-8727-c25c2bcf9fd6 2025-07-08 Warnings Exact identifier application number: M017 Publix hydro plus HYDROCORTISONE Publix Super Markets Inc a00d82c1-6b09-424a-be78-2603eee3fb9d 2025-07-08 Warnings Exact identifier application number: M017 Tattoo TATTOO CREAM Perfso (HK) Co., Limited 39773cab-12df-4520-e063-6294a90abc5b 2025-07-08 Warnings Exact identifier application number: M017 Neutrogena Sun Rescue After Sun Medicated Relief CAMPHOR (SYNTHETIC) Kenvue Brands LLC c95c5b64-b90f-1143-e053-2a95a90aa03c 2025-07-07 Warnings Exact identifier application number: M017 sunmark Hydrocortisone HYDROCORTISONE Strategic Sourcing Services LLC 210079e9-3d2f-4489-b468-b96b145034ed 2025-07-07 Warnings Exact identifier application number: M017 Relief Gel LIDOCAINE HCL Good Clean Love, Inc. e5fa2265-ccb7-750c-e053-2995a90aa51e 2025-07-07 Warnings Exact identifier application number: M017 Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 09ac2749-a60f-4039-8c80-a0d2eaf50c34 2025-07-07 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 2ada9ec2-1c28-4da2-8639-07b3193ffb32 2025-07-03 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE Sun Pharmaceutical Industries, Inc. caa2fd64-e262-4d7c-ad8a-69f506feba8c 2025-07-03 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