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 117 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join First Aid Only Sting Relief Pad BENZOCAINE Acme United Corporation 5087cbbd-1bbe-62ed-e054-00144ff8d46c 2024-11-19 Warnings Exact identifier application number: M017 Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL Acme United Corporation 6bb9a782-2394-4c8c-e053-2991aa0a08d4 2024-11-19 Warnings Exact identifier application number: M017 First Aid Only Sting Relief BENZOCAINE Acme United Corporation 697127d1-c02e-16d2-e053-2a91aa0a39fd 2024-11-19 Warnings Exact identifier application number: M017 First Aid Only Hydrocortisone 1% Anti-Itch HYDROCORTISONE Acme United Corporation e5597b11-b08e-99e1-e053-2a95a90a15a5 2024-11-19 Warnings Exact identifier application number: M017 Equate Cold Therapy Pain Relieving Roll-on Analgesic MENTHOL, UNSPECIFIED FORM Wal-Mart Stores, Inc. 4115f0ac-e12a-4e59-94f5-a47dcc7f8766 2024-11-18 Warnings Exact identifier application number: M017 Equate Cold Therapy Pain Relieving Analgesic MENTHOL, UNSPECIFIED FORM Wal-Mart Stores, Inc. ac6c2112-8692-4628-97d8-3a5a9f509766 2024-11-18 Warnings Exact identifier application number: M017 Equate Odor-Free Therapy Arthritis Analgesic TROLAMINE SALICYLATE Wal-Mart Stores, Inc. 1d73e7b6-c7f9-4680-b3e3-a954b91e1863 2024-11-18 Warnings Exact identifier application number: M017 First Aid Only Burn LIDOCAINE HYDROCHLORIDE Acme United Corporation 9af39fcd-0a57-26d0-e053-2a95a90a99a0 2024-11-17 Warnings Exact identifier application number: M017 First Aid Only First Aid/Burn LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE Acme United Corporation caa67a05-bdbd-c380-e053-2995a90a0bf1 2024-11-17 Warnings Exact identifier application number: M017 Meijer Pain Lidocaine Plus Relieving Analgesic BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc b7385140-3f63-4cbc-b557-de1d29d1ea36 2024-11-15 Warnings Exact identifier application number: M017 Signature Care Hydrocortisone HYDROCORTISONE Safeway c6b9c4e1-bab8-490d-8c00-c43377ad0857 2024-11-15 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Walgreen Company 1a9b8b4c-3e15-49e6-af91-76ed0dc0829e 2024-11-15 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Patrin Pharma Inc. 91eedf9d-53b8-49d5-af59-25019606a0b2 2024-11-15 Warnings Exact identifier application number: M017 equaline anti itch maximum strength HYDROCORTISONE United Natural Foods, Inc. dba UNFI d1ac686e-62f2-4177-8abc-8c7ca578de1a 2024-11-15 Warnings Exact identifier application number: M017 Meijer Pain Relieving Max Strength with Lavender Essential Oil Analgesic LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc e688967e-799a-4fc8-a19a-f0012b90e76b 2024-11-15 Warnings Exact identifier application number: M017 basic care hydrocortisone HYDROCORTISONE Amazon.com Services LLC a0d0e82b-03ff-4d43-9be0-0e414ee49970 2024-11-15 Warnings Exact identifier application number: M017 DG health hydrocortisone HYDROCORTISONE Dolgencorp, LLC 40710bae-32bb-47fd-b3dd-31d2c98ee70f 2024-11-15 Warnings Exact identifier application number: M017 Meijer Ultra Strength Pain Relieving Topical Analgesic CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Meijer Distribution, Inc 6319b019-8e17-4de1-b4e0-b402288a97d4 2024-11-15 Warnings Exact identifier application number: M017 Meijer Pain Relieving analgesic CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc 9953be94-5768-448f-83de-f5e53a2972cc 2024-11-15 Warnings Exact identifier application number: M017 careone anti itch HYDROCORTISONE American Sales Company 5f7b1435-ebee-4093-847a-79e8d6641404 2024-11-15 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