Home NDC 0113-4085 Mederma Advanced Scar
Product NDC 0113-4085
11-digit product format 001134085
Labeler code 0113
Product ID 0113-4085_9c3d9e08-9428-4b28-82a2-0cb24c3c92a3
Type HUMAN OTC DRUG
Nonproprietary name Allantoin
Dosage form GEL
Route TOPICAL
Labeler L. Perrigo Company
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-27
Substance ALLANTOIN
Active strength 5 mg/g
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 Mederma Advanced Scar
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLANTOIN 5 mg/g
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1442087 Internal RxNorm lookup 1442092 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 55 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0113-4085-20 00113408520 1 TUBE in 1 BOX (0113-4085-20) / 20 g in 1 TUBE 1 tube 2023-11-27 No No Current 0113-4085-50 00113408550 1 TUBE in 1 BOX (0113-4085-50) / 50 g in 1 TUBE 1 tube 2025-04-24 No No Current