Home NDC 80489-003-01 PAIN-X
Product NDC 80489-003
Requested package NDC 80489-003-01
11-digit product format 804890003
Labeler code 80489
Product ID 80489-003_2b51e8c1-1805-573d-e063-6294a90a2f58
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form GEL
Route TOPICAL
Labeler OL PHARMA TECH,LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-01
Substance MENTHOL, UNSPECIFIED FORM
Active strength 25 mg/g
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 PAIN-X
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 25 mg/g
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 282805 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-003 PAIN-X (MENTHOL) GEL [OL PHARMA TECH,LLC] 4 Current NDC, Legacy NDC, 4 package rows 20250112_b22bb19a-14e5-3d32-e053-2a95a90ae520.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 110 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultra Strength Muscle Rub CAMPHOR, MENTHOL, METHYL SALICYLATE The Mentholatum Company 32b64985-0e2f-49ee-9840-946d7279fee7 2024-12-17 Warnings Exact identifier application number: M017 CVS Health Cold and Hot Pain Relieving Extra Strength MENTHOL, METHYL SALICYLATE CVS Pharmacy 1ca1a631-cb2c-46cd-bd41-05469b08d208 2024-12-17 Warnings Exact identifier application number: M017 Mentholatum Pain Relieving MENTHOL, METHYL SALICYLATE The Mentholatum Company 0056b952-9870-485a-9f35-f985472875a9 2024-12-17 Warnings Exact identifier application number: M017 Mentholatum Lidocaine Heat LIDOCAINE HCL The Mentholatum Company cc2ef25a-b569-4d48-a666-899f710b4b34 2024-12-17 Warnings Exact identifier application number: M017 Rite Aid Muscle Rub Ultra Strength CAMPHOR, MENTHOL, METHYL SALICYLATE Rite Aid Corporation 039fff40-b5ba-42cb-932c-8a70ca92759d 2024-12-17 Warnings Exact identifier application number: M017 Signature Care Cold and Hot Medicated MENTHOL Safeway 88f59f95-0a7c-458c-949c-0dff16ad94e4 2024-12-17 Warnings Exact identifier application number: M017 Equate Cool and Heat MENTHOL, METHYL SALICYLATE Wal-Mart Stores Inc c5ab2426-eeca-4ba4-9f00-7790d2176471 2024-12-17 Warnings Exact identifier application number: M017 CVS Health Muscle Rub Ultra Strength CAMPHOR, MENTHOL, METHYL SALICYLATE CVS Pharmacy 4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a 2024-12-17 Warnings Exact identifier application number: M017 DG Health Maximum Strength Pain Relieving Cleansing BENZALKONIUM CL, LIDOCAINE HCL Dollar General Corporation 64f69315-77a3-49dc-940d-efd7a29c6645 2024-12-17 Warnings Exact identifier application number: M017 Chiggerex BENZOCAINE RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH 5e5d84ab-f57f-448d-a4c1-ced38890eec2 2024-12-17 Warnings Exact identifier application number: M017 DerMend Moisturizing Anti-Itch PRAMOXINE HYDROCHLORIDE Ferndale Laboratories, Inc. 14c7fb1c-a310-4b12-ab2e-7f1c0801995c 2024-12-17 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE Geri-Care Pharmaceuticals, Corp fd67566a-1076-019d-e053-6394a90a415c 2024-12-17 Warnings Exact identifier application number: M017 Extra Strength MENTHOL AND METHYL SALICYLATE NATURES FORMULAE HEALTH PRODUCTS LTD. d919b50a-5de2-1830-e053-2a95a90ab88d 2024-12-17 Warnings Exact identifier application number: M017 Cold and Heat Lidocaine Patch Plus Menthol LIDOCAINE, MENTHOL Walgreen Company 1f262473-3f3c-4f3f-b507-590d06ff69a9 2024-12-17 Warnings Exact identifier application number: M017 Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Walgreen Company db8cf218-7544-4871-b1c3-a50a3d3e59f1 2024-12-17 Warnings Exact identifier application number: M017 Albertsons Pain Relief Patch LIDOCAINE Safeway dc2823bb-8586-daca-e053-2995a90a2af0 2024-12-17 Warnings Exact identifier application number: M017 CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS CAPSAICIN Walgreen Company e77167ab-6cb8-4d5b-838c-b0acc05e3889 2024-12-17 Warnings Exact identifier application number: M017 Hot and Cold Medicated Patch MENTHOL Walgreen Company d9fc133d-ebaa-48f1-a6f9-62453970012b 2024-12-17 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Walgreen Company 204b96bc-af4e-4842-8b57-7b416feb4dd9 2024-12-17 Warnings Exact identifier application number: M017 Lidocaine Dry LIDOCAINE CVS bb7955fe-5113-1662-e053-2a95a90a85a1 2024-12-16 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 80489-003-01 80489000301 1 TUBE in 1 CARTON (80489-003-01) / 28.3 g in 1 TUBE 1 tube 2021-01-01 0000-00-00 No No Current