Home NDC 82568-0049 Benzoyl Peroxide
Product NDC 82568-0049
11-digit product format 825680049
Labeler code 82568
Product ID 82568-0049_5efef6c1-1d57-7e5b-e063-6294a90a5e5d
Type HUMAN OTC DRUG
Nonproprietary name Benzoyl Peroxide
Dosage form LIQUID
Route TOPICAL
Labeler AARNA USA INC.
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-25
Substance BENZOYL PEROXIDE
Active strength 100 mg/mL
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 Benzoyl Peroxide
Listing expiration 2027-12-31 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.
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 5 of 54 · 1,066 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82568-0049-5 82568004905 148 mL in 1 BOTTLE (82568-0049-5) 148 ml 2026-08-25 No No Current 82568-0049-8 82568004908 237 mL in 1 BOTTLE (82568-0049-8) 237 ml 2026-08-25 No No Current