Home NDC 71397-822 ACNE THERAPY
Product NDC 71397-822
11-digit product format 713970822
Labeler code 71397
Product ID 71397-822_09db5d2c-d37b-582f-e063-6294a90ae762
Type HUMAN OTC DRUG
Nonproprietary name BENZOYL PEROXIDE
Dosage form LOTION
Route TOPICAL
Labeler menScience Androceuticals, LLC
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-04-20
Substance BENZOYL PEROXIDE
Active strength 30 mg/g
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 ACNE THERAPY
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 30 mg/g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1548871 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 71397-822-55 ACNE THERAPY 45 g in 1 BOTTLE LOTION 45 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71397-822 ACNE THERAPY (BENZOYL PEROXIDE) LOTION [MENSCIENCE ANDROCEUTICALS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231112_4dec259d-200e-44f2-e054-00144ff8d46c.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 8 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 71397-822-55 71397082255 45 g in 1 BOTTLE (71397-822-55) 45 g 2017-04-20 0000-00-00 No No Current