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 113 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VAGISIL Anti-Itch Medicated Wipes Maximum Strength PRAMOXINE HYDROCHLORIDE Combe Incorporated b848f53d-8aea-4efe-aa2c-009d5121fc33 2024-12-12 Warnings Exact identifier application number: M017 Walgreens Cool and Heat MENTHOL 16% Walgreens ce1585f4-ca65-8d0c-e053-2995a90a8e89 2024-12-11 Warnings Exact identifier application number: M017 Walgreens Cool n Heat LIDOCAINE 4% Walgreens ce1b21d6-7aa6-2b18-e053-2995a90a4c91 2024-12-11 Warnings Exact identifier application number: M017 Walgreens Pain Burn Itch Relief BENZOCAINE 20%, MENTHOL 0.5% Walgreens cc6e4b42-fdd8-6ff7-e053-2995a90a3d1d 2024-12-11 Warnings Exact identifier application number: M017 Pramoxine Itch relief PRAMOXINE HCL 1% CVS e947694c-c122-0291-e053-2995a90ac39a 2024-12-11 Warnings Exact identifier application number: M017 Arthritis Cream TROLAMINE SALICYLATE 10% CVS d1663f50-479b-4d55-e053-2995a90a223f 2024-12-11 Warnings Exact identifier application number: M017 CVS Pain Relief MENTHOL 4% CVS d1660d55-1ee0-7aa2-e053-2995a90a6579 2024-12-11 Warnings Exact identifier application number: M017 CVS Muscle Rub MENTHOL 10%, METHYL SALICYLATE 15% CVS Health c72c9a95-4226-6d69-e053-2a95a90a8e1c 2024-12-11 Warnings Exact identifier application number: M017 BENGAY ULTRA STRENGTH NON-GREASY CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Kenvue Brands LLC 0a41ec65-bd0b-4fc6-807d-74f353341cc7 2024-12-11 Warnings Exact identifier application number: M017 Serum X LIDOCAINE HYDROCHLORIDE AO Biologix, LLC e07b6268-6400-6849-e053-2a95a90a8b3e 2024-12-11 Warnings Exact identifier application number: M017 PlusCBD Pain Cream (Penetrating) 2oz CAMPHOR, MENTHOL CV Sciences, Inc. ca39d327-6bf3-3408-e053-2a95a90af2d5 2024-12-11 Warnings Exact identifier application number: M017 Blistex Medicated DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL Blistex Inc. e95439d3-f12b-4c1c-999a-79f2ddba4cfb 2024-12-11 Warnings Exact identifier application number: M017 Blistex Foille Medicated First Aid BENZOCAINE AND CHLOROXYLENOL Blistex Inc. e2eca808-e97b-43e0-aa51-7025cc61c7a8 2024-12-11 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE J&A Digital Inc. ff95a536-35b3-4006-b43c-cce359e86aa9 2024-12-10 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE Alexso, Inc eef555d3-f23d-4847-93f3-fa7a06072a0f 2024-12-09 Warnings Exact identifier application number: M017 Lidocaine 4 Percent LIDOCAINE SA3, LLC 651710db-3c50-4bcf-b7cc-9ed24f663427 2024-12-09 Warnings Exact identifier application number: M017 HealthWise Pain Relief Lidocaine Patch LIDOCAINE 4% Veridian Healthcare 28db1c03-d01f-83ea-e063-6294a90aee26 2024-12-09 Warnings Exact identifier application number: M017 Joint and Muscle Pain Relief MENTHOL Allure Labs e82f99fd-c2ef-686f-e053-2a95a90a1dc9 2024-12-09 Warnings Exact identifier application number: M017 Tough Love Pain Relieving LIDOCAINE HCL Allure Labs ee8c1a2b-36ef-6fd7-e053-2a95a90a9c01 2024-12-09 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN SA3, LLC 5617e91d-e650-4a0d-8565-b8288ea41c77 2024-12-09 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