Home NDC 80425-0543 MENTHOL 5%
Product NDC 80425-0543
11-digit product format 804250543
Labeler code 80425
Product ID 80425-0543_3bdd0c39-8004-0b8f-e063-6394a90aa5f4
Type HUMAN OTC DRUG
Nonproprietary name menthol 5%
Dosage form PATCH
Route TRANSDERMAL
Labeler Advanced Rx of Tennessee, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-08
Substance MENTHOL, (+)-
Active strength 500 mg/10g
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 MENTHOL 5%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, (+)- 500 mg/10g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C6B1OE8P3W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 420222 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80425-0543-1 MENTHOL 5% 30 in 1 BOX PATCH 30 1 80425-0543-1 MENTHOL 5% 11 g in 1 PATCH PATCH 11 1
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 Sample Exclude flag Status 80425-0543-1 80425054301 30 PATCH in 1 BOX (80425-0543-1) / 11 g in 1 PATCH 30 patch 2025-08-08 No No Current