Home NDC 80465-003 MENTHOL, CAMPHOR
Product NDC 80465-003
11-digit product format 804650003
Labeler code 80465
Product ID 80465-003_137c6781-8bba-de23-e063-6394a90a6abb
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, CAMPHOR
Dosage form CREAM
Route TOPICAL
Labeler EROS GLOBAL
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-11-04
Substance MENTHOL; CAMPHOR (NATURAL)
Active strength 3; 3 g/100g; g/100g
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, CAMPHOR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 3 g/100g CAMPHOR (NATURAL) 3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup N20HL7Q941 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2606068 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80465-003-04 MENTHOL, CAMPHOR 113 g in 1 BOTTLE CREAM 113 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80465-003 MENTHOL, CAMPHOR CREAM [EROS GLOBAL] 4 Current NDC, Legacy NDC, 1 package rows 20240321_b3495c95-ba4b-9459-e053-2a95a90a710f.zip
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 100 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Family Wellness Max Strength 1 Hydrocortisone Cream HYDROCORTISONE Family Dollar Stores, Inc bca5ac2c-45cd-44e3-98f1-317a04e44d7d 2025-02-25 Warnings Exact identifier application number: M017 Tylenol Precise Nighttime Pain Relieving CAMPHOR, MENTHOL Kenvue Brands LLC 2ef4fe16-0820-6aad-e063-6294a90a8449 2025-02-25 Warnings Exact identifier application number: M017 LidoPro Pain Relief CAPSAICIN AND LIDOCAINE Preferred Pharmaceuticals Inc. c259ef92-5d07-4590-adf1-3a106333eee0 2025-02-21 Warnings Exact identifier application number: M017 Cortizone 10 Ultra Soothing Itch Relief HYDROCORTISONE Chattem, Inc. 8a9e2d32-a65f-4253-8041-4146f4e3b738 2025-02-21 Warnings Exact identifier application number: M017 AVCOO Pain Relief Roll On MENTHOL ADP Health Limited 420d8cdc-f47f-4d33-bf25-9033ff266c49 2025-02-19 Warnings Exact identifier application number: M017 AVCOO Pain Relief MENTHOL ADP Health Limited 700ce2cf-749e-40be-91c3-850d9b2168ca 2025-02-19 Warnings Exact identifier application number: M017 Sunburn Relief Gel LIDOCAINE HCL Jell Pharmaceuticals Pvt. Ltd 2e7c49de-5438-4858-e063-6294a90ad98c 2025-02-19 Warnings Exact identifier application number: M017 VTROUY Tattoo Numbing Cream TATTOO NUMBING CREAM Guangzhou Zanming Trading Co., Ltd. 2e899851-b3cd-0758-e063-6294a90afea8 2025-02-19 Warnings Exact identifier application number: M017 Pomada Dragon Pain Relief MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATE Genomma Lab USA 9d98f48b-6d88-4df9-9459-7cf7ba5de044 2025-02-19 Warnings Exact identifier application number: M017 Pain Relieving Cream HISTAMINE DIHYDROCHLORIDE Mediapower, Inc. DBA Dr Newton's And Naturals 9eeea033-ae87-4d83-85d0-b8fa653a0806 2025-02-19 Warnings Exact identifier application number: M017 Sure Complete Confidence Antiperspirant Deodorant Aerosol, Regular ALUMINUM CHLOROHYDRATE Sodalis USA, LLC 7839cf53-dbd2-4dbb-a309-1581d51f8adc 2025-02-18 Warnings Exact identifier application number: M017 CANNA NUMB Roll On LIDOCAINE HYDROCHLORIDE, MENTHOL Cannanumb LLC c1eb0348-3b0e-4f1c-a46b-1ff4aa165fb4 2025-02-17 Warnings Exact identifier application number: M017 Vaporizing Chest Rub 4 oz. CAMPHOR, EUCALYPTUS OIL, MENTHOL Rejoice International Inc. 7173b141-123e-6cd4-e053-2a95a90a8600 2025-02-12 Warnings Exact identifier application number: M017 Vaporizing Chest Rub 4 oz. 3 pk CAMPHOR, EUCALYPTUS OIL, MENTHOL Rejoice International Inc. 71c186a1-8283-2482-e053-2995a90acc1f 2025-02-12 Warnings Exact identifier application number: M017 Roman Swipes BENZOCAINE Roman Health Ventures Inc. 7f0eac8c-7235-99d8-e053-2a91aa0a634e 2025-02-12 Warnings Exact identifier application number: M017 SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOR EVI LABS EVI LABS 2df7658d-83d3-41ac-e063-6294a90ab1dd 2025-02-12 Warnings Exact identifier application number: M017 Signature Care Medicated Pain Relief Patch LIDOCAINE Safeway, Inc. 2165a342-5f8b-78e0-e063-6394a90a06c4 2025-02-12 Warnings Exact identifier application number: M017 CheeZheng Pain Relieveing Plaster CAMPHOR Tibet Cheezheng Tibetan Medicine Co. Ltd. abcebdf1-9037-4094-93e1-ce8f20b18ea7 2025-02-11 Warnings Exact identifier application number: M017 Tibetree Pain Relieveing Medicated Plaster CAMPHOR Tibet Cheezheng Tibetan Medicine Co. Ltd 4216bd48-5c62-4e87-adcc-67bf7152d64d 2025-02-11 Warnings Exact identifier application number: M017 AsperFlex LIDOCAINE Akron Pharma Inc. ab50525e-b534-452b-8c25-2992c0cbf862 2025-02-10 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80465-003-04 80465000304 113 g in 1 BOTTLE (80465-003-04) 113 g 2020-11-04 0000-00-00 No No Current