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 113 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Tommie Copper Pain Relief Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. b6c3d6eb-b485-33b8-e053-2a95a90a41e1 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. b4cd4fed-e8c8-db85-e053-2995a90a708b 2024-12-15 Warnings Exact identifier application number: M017 Copperlife Pain Relief Liquid MENTHOL 16% Tommie Copper, Inc. c93a0139-953b-5523-e053-2a95a90a0b2d 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief TROLAMINE SALICYLATE 10% Tommie Copper, Inc. ca011b03-a263-1908-e053-2995a90ad970 2024-12-15 Warnings Exact identifier application number: M017 Warrior Chiggerex Relief BENZOCAINE 10% Derma Care Research Labs, LLC dcf2f52b-2295-58e5-e053-2995a90a7fd8 2024-12-15 Warnings Exact identifier application number: M017 Capsaicin Cream CAPSAICIN Trifecta Pharmaceuticals USA LLC def8d341-06a7-0e9b-e053-2995a90a0ad6 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Original CAMPHOR, MENTHOL The Mentholatum Company 19e4b812-67c6-49fd-833a-b432100363f5 2024-12-13 Warnings Exact identifier application number: M017 Cold and Hot Medicated MENTHOL The Mentholatum Company 85bf425d-59d7-4462-ba46-292145460099 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Lidocaine Ice LIDOCAINE HCL, MENTHOL The Mentholatum Company 4d74cbab-31cd-4579-9360-6852ee215b5e 2024-12-13 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