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 72 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coralite Muscle and Joint Pain Relief CAPSACIN United Exchange Corp. ba9a3d72-db7a-4dd0-9220-f43c9ed87114 2025-10-21 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Wrist MENTHOL United Exchange Corp. ae314478-b8ab-4e90-bd0a-7a882d5c1b2e 2025-10-21 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 85bd7658-e951-7daf-e053-2a91aa0a9f54 2025-10-21 Warnings Exact identifier application number: M017 Family Care Maximum Strength Medicated Anti Itch MENTHOL United Exchange Corp. 430b5753-3087-4cb1-bf54-0eedc3f4b1d5 2025-10-21 Warnings Exact identifier application number: M017 Family Care Anti-Itch HYDROCORTISONE United Exchange Corp. 8e4d46d8-7084-0666-e053-2995a90ad520 2025-10-21 Warnings Exact identifier application number: M017 Coralite Pain Relief CAMPHOR, MENTHOL, METHYL SALICYLATE United Exchange Corp. 69aec845-3d4c-d226-e053-2991aa0afd12 2025-10-21 Warnings Exact identifier application number: M017 WHITE FLOWER ANALGESIC BALM CAMPHOR, MENTHOL AND METHYL SALICYLATE HOE HIN PAK FAH YEOW MANUFACTORY LTD f3e3b8b5-b12b-49ac-9318-b0c358b136e9 2025-10-21 Warnings Exact identifier application number: M017 Mountain Ice Sports Recovery MENTHOL Mountainside Medical Equipment, Inc. 98638529-3c17-436e-901f-c8aea52bdab6 2025-10-20 Warnings Exact identifier application number: M017 Lip Clear Lysine Plus MENTHOL, UNSPECIFIED FORM Quantum, Inc. 21a5b4fb-baed-4766-9820-5c6051c14720 2025-10-20 Warnings Exact identifier application number: M017 Buzz Away Sting Soothe MENTHOL Quantum, Inc. 419e34ea-17b2-ec32-e063-6394a90a603d 2025-10-20 Warnings Exact identifier application number: M017 Family Care Anti-Itch HYDROCORTISONE United Exchange Corp. deb09e89-9794-89a7-e053-2a95a90abdf8 2025-10-20 Warnings Exact identifier application number: M017 Numbing Cream MENTHOL FlexiGo Inc 41571c8f-332b-f423-e063-6394a90a8897 2025-10-20 Warnings Exact identifier application number: M017 Soothing Nerve Therapy MENTHOL Wise Consumer Products 40829d6b-5005-7ec9-e063-6294a90a970e 2025-10-20 Warnings Exact identifier application number: M017 Numbing Cream MENTHOL FlexiGo Inc 4146fd51-b18c-393d-e063-6294a90a4d9a 2025-10-20 Warnings Exact identifier application number: M017 Lidocaine 4% Maximum OTC Strength LIDOCAINE Cardinal Health 107, LLC 975031df-d46d-4098-b1c0-1c0c92b41995 2025-10-20 Warnings Exact identifier application number: M017 Cortizone 10 Intensive Healing HYDROCORTISONE Chattem, Inc. bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c 2025-10-20 Warnings Exact identifier application number: M017 Sting relief pad BENZOCAINE, ALCOHOL Guangdong Comfort Medical Products Co., Ltd. 6e905065-10a9-1ded-e053-2a91aa0a46a1 2025-10-19 Warnings Exact identifier application number: M017 Elgin Pain Relief MENTHOL Eco-Logics, Inc. 375bfe83-c895-3ea7-e054-00144ff88e88 2025-10-18 Warnings Exact identifier application number: M017 Advanced Healing Diabetic Skin Care DIMETHICONE Eco-Logics, Inc. c6704d06-0311-406e-98a7-b8c8881aefd5 2025-10-18 Warnings Exact identifier application number: M017 Elgin Pain Relief MENTHOL Eco-Logics, Inc. 378d1109-6511-1f63-e054-00144ff88e88 2025-10-18 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