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 94 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens Stop Itch Gel DIPHENHYDRAMINE HCL Walgreens Co 23586336-8f46-3dcd-e063-6394a90accc9 2025-05-04 Warnings Exact identifier application number: M017 WaxRx EarAcheRx Pain Relieving Drops 4% LIDOCAINE HCL DOCTOR EASY MEDICAL PRODUCTS, LLC 34156655-8706-f0a4-e063-6294a90acc90 2025-05-01 Warnings Exact identifier application number: M017 foster and thrive anti itch cream DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Strategic Sourcing Services LLC bb08293d-5db8-4cc8-9fe3-bd02061dbeb9 2025-04-30 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch LIDOCAINE Solis Pharmaceuticals Inc. 3061d301-2104-b1b2-e063-6394a90a9b6e 2025-04-29 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch LIDOCAINE InterMed Laboratories Private Limited 33ed754e-8852-d5b2-e063-6394a90a7cf2 2025-04-29 Warnings Exact identifier application number: M017 Cold Hot Medicated Patch 5% Menthol MENTHOL InterMed Laboratories Private Limited 33ee6e48-243e-4ded-e063-6394a90a987d 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 32b96689-8e9b-4c2e-e063-6294a90a7d1c 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3304e362-dcda-3f5e-e063-6294a90a7015 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 2f2f753d-c791-e863-e063-6394a90aec5d 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3162c96a-061d-2971-e063-6394a90a9b74 2025-04-29 Warnings Exact identifier application number: M017 Ivarest Poison Ivy Removal and Itch Relief PRAMOXINE HYDROCHLORIDE Blistex Inc. dedbf5d9-0f86-4f32-8321-da86c9838c0a 2025-04-29 Warnings Exact identifier application number: M017 HealthWise 2X Medicated Pain Relief Cream Roll-on MENTHOL Veridian Healthcare 33dae8a8-4197-f276-e063-6294a90aea83 2025-04-28 Warnings Exact identifier application number: M017 HealthWise Roll-on Menthol Pain Relief Gel MENTHOL Veridian Healthcare 33dbb939-9397-7e70-e063-6294a90ac8f4 2025-04-28 Warnings Exact identifier application number: M017 Stopain Extra Strength Gel MENTHOL Troy Manufacturing, Inc. fa1a98bc-c233-410d-a20e-71111c897372 2025-04-28 Warnings Exact identifier application number: M017 Lidocaine Patch 4% LIDOCAINE 4% Medcore LLC b961906c-fe66-466b-af2c-072781fa098b 2025-04-28 Warnings Exact identifier application number: M017 Walgreens Lidocaine Knee and Elbow LIDOCAINE Walgreen Co. a3fb4c78-1493-4ba4-ae83-502dd825ed67 2025-04-25 Warnings Exact identifier application number: M017 Walgreens Lidocaine Back LIDOCAINE Walgreen Co. e6bfd342-c0db-46b9-b5e6-5acbd860adf1 2025-04-25 Warnings Exact identifier application number: M017 Electrum Numb Foam LIDOCAINE HCI RENU LABORATORIES, LLC c8472932-28b7-9189-e053-2a95a90a44df 2025-04-25 Warnings Exact identifier application number: M017 Benadryl Extra Strength Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE Kenvue Brands LLC 66a2fd60-1757-45cc-a195-ecb9241dca2a 2025-04-24 Warnings Exact identifier application number: M017 Jakwork Numbing Cream NUMBING CREAM Guangzhou Zanming Trading Co., Ltd. 3385cddb-609f-62e8-e063-6294a90add81 2025-04-24 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