Home NDC 35573-453 Benzoyl Peroxide
Product NDC 35573-453
11-digit product format 355730453
Labeler code 35573
Product ID 35573-453_d51a6f4b-982d-45aa-932f-a9527b294289
Type HUMAN OTC DRUG
Nonproprietary name Benzoyl Peroxide
Dosage form LIQUID
Route TOPICAL
Labeler Burel Pharmaceuticals, LLC
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-15
Substance BENZOYL PEROXIDE
Active strength 50 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 50 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 35573-453-08 Benzoyl Peroxide 237 mL in 1 BOTTLE LIQUID 237 4 35573-453-91 Benzoyl Peroxide 148 mL in 1 BOTTLE LIQUID 148 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35573-453 BENZOYL PEROXIDE LIQUID [BUREL PHARMACEUTICALS, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240726_0617d42d-511d-4c1a-a919-b37abbc14efc.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 7 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 Marketing end Sample Exclude flag Status 35573-453-08 35573045308 237 mL in 1 BOTTLE (35573-453-08) 237 ml 2022-04-15 0000-00-00 No No Current 35573-453-91 35573045391 148 mL in 1 BOTTLE (35573-453-91) 148 ml 2022-04-15 0000-00-00 No No Current