Home NDC 80489-003 PAIN-X
Product NDC 80489-003
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 122 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sanar Naturals Arnica Reforzada CAMPHOR Sanvall Enterprises, Inc 1921a4b1-cd36-195e-e063-6294a90a8793 2024-10-31 Warnings Exact identifier application number: M017 Sanar Naturals Arnica Pain Releiving Roll On with Camphor CAMPHOR Sanvall Enterprises, Inc 173db0e2-611f-55b9-e063-6394a90ac987 2024-10-31 Warnings Exact identifier application number: M017 Sanar Naturals Camphor CAMPHOR Sanvall Enterprises, Inc 1921e851-cf83-0bdb-e063-6294a90a357f 2024-10-31 Warnings Exact identifier application number: M017 cortisone HYDROCORTISONE CVS Pharmacy c766deac-d993-4e48-a5c3-4cfde7338dff 2024-10-31 Warnings Exact identifier application number: M017 Walgreens Pain Relieving with Lavender Analgesic LIDOCAINE HYDROCHLORIDE Walgreen Company 6c7b39c8-5b65-430a-a529-5b6b14adce18 2024-10-31 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Plus Turmeric Analgesic TROLAMINE SALICYLATE Walgreen Company f3a121bc-7572-49a4-9822-2b6d858c19d2 2024-10-31 Warnings Exact identifier application number: M017 dg health hydrocortisone HYDROCORTISONE Dolgencorp, LLC 27dc9e09-fc4f-4b66-a303-177725f3a513 2024-10-31 Warnings Exact identifier application number: M017 basic care hydrocortisone HYDROCORTISONE Amazon.com Services LLC f5419859-3f9f-43ff-9a3f-6aa81af044f0 2024-10-31 Warnings Exact identifier application number: M017 ARCTIC RELIEF MENTHOL, UNSPECIFIED FORM STRATUS PHARMACEUTICALS INC d27fbc17-46b7-4d52-ba29-c99b6c63144a 2024-10-31 Warnings Exact identifier application number: M017 Pain Relief Gel-Patch LIDOCAINE, MENTHOL R & Y Group, LLC fe0478d8-2f06-cd56-e053-6294a90a58e5 2024-10-30 Warnings Exact identifier application number: M017 JOINT-RITIS PAIN RELIEVING ROLL-ON MENTHOL Lifeline Naturals of America, Inc. ec5d99c4-6bba-45d1-84e0-12fb7cb31495 2024-10-30 Warnings Exact identifier application number: M017 Walgreens Pain Relieving with Turmeric Analgesic LIDOCAINE HYDROCHLORIDE Walgreen Company 317ec4fb-cff0-461d-9ca0-299527a3686d 2024-10-30 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Analgesic CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Walgreen Company 3215a676-104c-43c3-aa36-b30d5b67799a 2024-10-30 Warnings Exact identifier application number: M017 Ultra-Strength Pain Relief Analgesic CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM TARGET CORPORATION 159c5a84-bf68-41dd-a2d3-bc2402037244 2024-10-30 Warnings Exact identifier application number: M017 DG Health Cold n Hot Pain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM Dolgencorp Inc 8fe13b85-ab74-42f8-a664-d3d2959921ac 2024-10-30 Warnings Exact identifier application number: M017 DEBACHERE Butt Balm After Care Antiseptic Pain Relief BENZOCAINE, BENZALKONIUM CHLORIDE DE.BACHERE USA LLC 8ba42864-69bf-455c-98d4-7f4ff94edceb 2024-10-29 Warnings Exact identifier application number: M017 Signature Care Hydrocortisone HYDROCORTISONE Safeway beefab66-b056-4bf1-b047-0780704ab87e 2024-10-29 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE H E B 15eb4676-5f6e-4c28-b5b9-4e45412dc37a 2024-10-29 Warnings Exact identifier application number: M017 Rael PAIN RELIEF ROLL-ON Analgesic CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM Rael, Inc. e6c49606-7c13-4dc6-a22d-ba54173ba788 2024-10-28 Warnings Exact identifier application number: M017 Monistat Care Instant Itch Relief BENZOCAINE Insight Pharmaceuticals LLC 4e9dc791-419f-4c79-aed4-760f8c17a5dd 2024-10-25 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 80489-003-02 80489000302 1 TUBE in 1 CARTON (80489-003-02) / 49.6 g in 1 TUBE 1 tube 2021-01-01 0000-00-00 No No Current