Home NDC 80861-013 Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide
Product NDC 80861-013
11-digit product format 808610013
Labeler code 80861
Product ID 80861-013_57f487d5-bb4d-31a0-e063-6294a90ac3dc
Type HUMAN OTC DRUG
Nonproprietary name BENZOYL PEROXIDE
Dosage form LIQUID
Route TOPICAL
Labeler AcneFree LLC
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-12-01
Substance BENZOYL PEROXIDE
Active strength 25 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 Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 25 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 845836 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 80861-013-01 Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80861-013 ACNE FREE OIL FREE ACNE CLEANSER 2.5 BENZOYL PEROXIDE (BENZOYL PEROXIDE) LIQUID [ACNEFREE LLC] 5 Current NDC, Legacy NDC, 1 package rows 20240620_c939847a-72cc-96fa-e053-2a95a90a4f9c.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 80861-013-01 80861001301 237 mL in 1 BOTTLE, PLASTIC (80861-013-01) 237 ml 2017-12-01 0000-00-00 No No Current