Home NDC 83520-131 Dermachange Cold Therapy
Product NDC 83520-131
11-digit product format 835200131
Labeler code 83520
Product ID 83520-131_12ef7dd8-3da2-9c87-e063-6394a90ac924
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form GEL
Route TOPICAL
Labeler Private Label Beauty and Wellness
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-27
Substance MENTHOL
Active strength 2 g/100g
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 Dermachange Cold Therapy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 2 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 311502 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 83520-131-08 Dermachange Cold Therapy 227 g in 1 JAR GEL 227 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83520-131 DERMACHANGE COLD THERAPY (MENTHOL) GEL [PRIVATE LABEL BEAUTY AND WELLNESS] 1 Current NDC, 1 package rows 20240307_12ef7dd8-3da3-9c87-e063-6394a90ac924.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 Sample Exclude flag Status 83520-131-08 83520013108 227 g in 1 JAR (83520-131-08) 227 g 2023-10-27 No No Current