Home NDC 80489-004 MUSCLE RUB
Product NDC 80489-004
11-digit product format 804890004
Labeler code 80489
Product ID 80489-004_2b522348-ac98-f41f-e063-6294a90aef45
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 MUSCLE RUB
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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80489-004-01 MUSCLE RUB 1 in 1 CARTON GEL 1 5 80489-004-01 MUSCLE RUB 28.3 g in 1 TUBE GEL 28.3 5 80489-004-02 MUSCLE RUB 49.6 g in 1 TUBE GEL 49.6 5 80489-004-02 MUSCLE RUB 1 in 1 CARTON GEL 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-004 MUSCLE RUB (MENTHOL) GEL [OL PHARMA TECH,LLC] 5 Current NDC, Legacy NDC, 4 package rows 20250112_b22c7999-52d5-25c3-e053-2a95a90a01f5.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 18 of 153 · 3,057 matching rows.
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 80489-004-01 80489000401 1 TUBE in 1 CARTON (80489-004-01) / 28.3 g in 1 TUBE 1 tube 2021-01-01 0000-00-00 No No Current 80489-004-02 80489000402 1 TUBE in 1 CARTON (80489-004-02) / 49.6 g in 1 TUBE 1 tube 2021-01-01 0000-00-00 No No Current