Home NDC 82461-313 BENZOYL PEROXIDE 10% Topical wash
Product NDC 82461-313
11-digit product format 824610313
Labeler code 82461
Product ID 82461-313_14cd67f2-dc7d-484b-bd21-bcb09c7f779e
Type HUMAN OTC DRUG
Nonproprietary name BENZOYL PEROXIDE
Dosage form LIQUID
Route TOPICAL
Labeler Medcore LLC
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-20
Substance BENZOYL PEROXIDE
Active strength 100 mg/mL
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 BENZOYL PEROXIDE 10% Topical wash
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W9WZN9A0GM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 142034 Internal RxNorm lookup 308696 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 82461-313-05 BENZOYL PEROXIDE 10% Topical wash 148 mL in 1 BOTTLE, PUMP LIQUID 148 1 82461-313-08 BENZOYL PEROXIDE 10% Topical wash 236 mL in 1 BOTTLE, PUMP LIQUID 236 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 14 of 55 · 1,088 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 82461-313-05 82461031305 148 mL in 1 BOTTLE, PUMP (82461-313-05) 148 ml 2025-10-20 No No Current 82461-313-08 82461031308 236 mL in 1 BOTTLE, PUMP (82461-313-08) 236 ml 2025-10-20 No No Current