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 111 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HealthWise Medicated Original Body Powder 10 oz MENTHOL Veridian Healthcare 296b623a-14cd-0bca-e063-6394a90ac5ff 2024-12-16 Warnings Exact identifier application number: M017 HealthWise Medicated Extra Body Powder 10 oz MENTHOL Veridian Healthcare 296c9a9c-e3db-59fe-e063-6294a90a0b62 2024-12-16 Warnings Exact identifier application number: M017 Rite Aid Hot and Cold Roll On MENTHOL 16% Rite Aid fc4b2635-280b-267f-e053-6294a90a5e22 2024-12-15 Warnings Exact identifier application number: M017 Rite Aid Pain Relieving BENZOCAINE 20%, MENTHOL 0.5% Rite Aid e2c09e85-be0a-4e6d-e053-2995a90ad756 2024-12-15 Warnings Exact identifier application number: M017 Rugby Lidocaine LIDOCAINE 4% Rugby Laboratories d94292f7-10fc-48bf-e053-2995a90a8472 2024-12-15 Warnings Exact identifier application number: M017 Rite Aid Cortisone HYDROCORTISONE 1% Rite Aid e27353b9-23b6-3801-e053-2a95a90a6045 2024-12-15 Warnings Exact identifier application number: M017 Rite Aid Cooling Pain Relief MENTHOL 10.5% Rite Aid e2225259-70ec-52de-e053-2a95a90a73f8 2024-12-15 Warnings Exact identifier application number: M017 Rite Aid Rectal Care LIDOCAINE 5% Rite Aid e283e462-96e8-04cf-e053-2a95a90a1d00 2024-12-15 Warnings Exact identifier application number: M017 Rite Aid Anti-Itch DIPHENHYDRAMINE HCL 2% Rite Aid e33898d8-1b8b-5c0b-e053-2995a90add08 2024-12-15 Warnings Exact identifier application number: M017 Rite Aid Cala Itch Relief PRAMOXINE HCL 1%, ZINC ACETATE 0.1% Rite Aid e29a9d59-4c7c-81aa-e053-2995a90a7056 2024-12-15 Warnings Exact identifier application number: M017 CVS Roll-On CAPSAISIN 0.1% CVS e8812c49-335e-61ea-e053-2995a90a17aa 2024-12-15 Warnings Exact identifier application number: M017 Good Sense Burn Relief Aloe LIDOCAINE HCL Geiss, Destin & Dunn, Inc b5a7f629-a88d-b49d-e053-2995a90a49fa 2024-12-15 Warnings Exact identifier application number: M017 QC Burn Relief Aloe LIDOCAINE HCL Chain Drug Marketing Association Inc b5e76f0c-0bfe-b13e-e053-2995a90a0861 2024-12-15 Warnings Exact identifier application number: M017 Meijer Burn Relief LIDOCAINE 0.5% Meijer bec60c93-5abd-ee04-e053-2a95a90acb61 2024-12-15 Warnings Exact identifier application number: M017 QC Cool and Heat Roll-On MENTHOL 16% Chain Drug Marketing Association Inc d35e9dfa-8a28-fdb3-e053-2995a90abc52 2024-12-15 Warnings Exact identifier application number: M017 Meijer Cold and Hot Pain Relieving MENTHOL 16% Meijer bec62df3-06c9-a115-e053-2995a90a4267 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief MENTHOL 16% Tommie Copper, Inc. b4dfa5fa-2d61-db1e-e053-2a95a90a7ac8 2024-12-15 Warnings Exact identifier application number: M017 Pain Relief Liquid Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. c9f0447e-de43-16a5-e053-2995a90a05c1 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Maximum Strength TROLAMINE SALICYLATE 10% Tommie Copper, Inc. b622c14f-9bf3-0bbd-e053-2a95a90a2adc 2024-12-15 Warnings Exact identifier application number: M017 Copperlife Pain Relief TROLAMINE SALICYLATE 10% Tommie Copper, Inc. c94d00f9-42ce-1d43-e053-2a95a90a058d 2024-12-15 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