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 120 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Acme United Corporation f1f051ad-7e82-9d1a-e053-2a95a90ac7d3 2024-11-12 Warnings Exact identifier application number: M017 HYDROCORTISONE HYDROCORTISONE ALLIED TRADE LINK LLC 26bc238d-3bda-0c29-e063-6394a90a35fb 2024-11-12 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Acme United Corporation fabcaa3b-d189-bd29-e053-6294a90ae86b 2024-11-12 Warnings Exact identifier application number: M017 ActivICE MENTHOL Medline Industries, LP 8414aea2-52b5-4221-e053-2a91aa0a622e 2024-11-12 Warnings Exact identifier application number: M017 Pain Relieving Gel-Patch LIDOCAINE Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 26c7116f-c86d-8752-e063-6294a90ab73f 2024-11-12 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Kroger Company fc1677f2-4078-4ebd-9c3b-86a29a35b489 2024-11-12 Warnings Exact identifier application number: M017 CVS Health Lidocaine Cream LIDOCAINE CVS Health ad950680-c03c-4fa5-aa7f-239a889cd097 2024-11-12 Warnings Exact identifier application number: M017 CVS Arthritis Pain Relief ARTHRITIS PAIN RELIEF CVS Health 575dd514-fd99-4e44-8fc8-52938f9abc26 2024-11-11 Warnings Exact identifier application number: M017 ThermaPatch (TM) Lidocaine Pain Relief Patch LIDOCAINE PAIN RELIEF PATCH Henan Enokon Medical Instrument Co., Ltd. 26769590-cd50-1b01-e063-6394a90a445c 2024-11-09 Warnings Exact identifier application number: M017 DG Health Cold Zone Pain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM Dolgencorp Inc 22594ab8-9a4a-426f-aced-5c636620fa2c 2024-11-08 Warnings Exact identifier application number: M017 Peviderm Pramoxine Hydrocholride 1% PRAMOXINE HYDROCHLORIDE Stratus Pharmaceuticals Inc 680b40fa-1922-443a-a4b0-7c3f6a2b847d 2024-11-07 Warnings Exact identifier application number: M017 Meijer Analgesic with Aloe Topical Analgesic TROLAMINE SALICYLATE Meijer Distribution, Inc f6c1e09e-4c61-4c2a-87d7-b052ed36fcac 2024-11-07 Warnings Exact identifier application number: M017 Meijer Pain Relieving Balm Analgesic TROLAMINE SALICYLATE Meijer Distribution, Inc 1b7535cc-01ac-49f0-9889-dd14b254d4ae 2024-11-07 Warnings Exact identifier application number: M017 BENGAY Tropical Jasmine LIDOCAINE Kenvue Brands LLC c416320a-c0d7-401e-b0fa-44114d76a557 2024-11-06 Warnings Exact identifier application number: M017 Bengay Ultra Strength Large Size MENTHOL, UNSPECIFIED FORM Kenvue Brands LLC f57ccc33-400b-4401-a348-c54d1eb9f5d0 2024-11-06 Warnings Exact identifier application number: M017 Band Aid Antiseptic Cleansing To Go BENZALKONIUM CHLORIDE, PRAMOXINE HCL Kenvue Brands LLC d5749cba-32f3-cf9c-e053-2a95a90a4416 2024-11-06 Warnings Exact identifier application number: M017 Pain Relieving Cream CAMPHOR AND MENTHOL GOLDEN TIGER DISTRIBUTION L.L.C. 26473383-282c-fb10-e063-6394a90a5fa2 2024-11-06 Warnings Exact identifier application number: M017 Pain Relieving Cream CAMPHOR AND MENTHOL GOLDEN TIGER DISTRIBUTION L.L.C. 1b6f929a-db65-8a02-e063-6394a90a8b59 2024-11-06 Warnings Exact identifier application number: M017 Meijer Maximum Strength Pain Relieving Analgesic MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc bd6f04f9-a23b-45f6-bce2-1ef7203198e1 2024-11-06 Warnings Exact identifier application number: M017 Meijer Cold and Hot Pain Relieving Analgesic LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc 6d356563-9098-4994-8ad8-819a8033a9f4 2024-11-06 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