Home NDC 83520-297 Dermachange Scar
Product NDC 83520-297
11-digit product format 835200297
Labeler code 83520
Product ID 83520-297_12eed473-10d9-49c8-e063-6394a90afb63
Type HUMAN OTC DRUG
Nonproprietary name Allantoin
Dosage form GEL
Route TOPICAL
Labeler Private Label Beauty and Wellness
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-27
Substance ALLANTOIN
Active strength .5 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 Scar
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLANTOIN .5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 344S277G0Z Internal UNII 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 83520-297-00 Dermachange Scar 19.8 g in 1 TUBE GEL 19.8 1 83520-297-00 Dermachange Scar 1 in 1 BOX GEL 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83520-297 DERMACHANGE SCAR (ALLANTOIN) GEL [PRIVATE LABEL BEAUTY AND WELLNESS] 1 Current NDC, 2 package rows 20240307_12eed473-10d6-49c8-e063-6394a90afb63.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 44 of 68 · 1,346 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83520-297-00 83520029700 1 TUBE in 1 BOX (83520-297-00) / 19.8 g in 1 TUBE 1 tube 2024-02-27 No No Current