Home NDC 52000-442 4% MENTHOL COLD THERAPY
Product NDC 52000-442
11-digit product format 520000442
Labeler code 52000
Product ID 52000-442_b0944dc2-c53e-45e3-92f0-2b45bcb277a3
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form GEL
Route TOPICAL
Labeler Universal Distribution Center LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-19
Substance MENTHOL, UNSPECIFIED FORM
Active strength 4 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 4% MENTHOL COLD THERAPY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 4 g/100g
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 415974 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 52000-442-15 4% MENTHOL COLD THERAPY 42.5 g in 1 TUBE GEL 42.5 1 52000-442-15 4% MENTHOL COLD THERAPY 1 in 1 BOX GEL 1 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 52000-442-15 52000044215 1 TUBE in 1 BOX (52000-442-15) / 42.5 g in 1 TUBE 1 tube 2026-01-19 No No Current