Home NDC 80861-010 Acne Free SEVERE ACNE 24 HR Acne Clearing System
Product NDC 80861-010
11-digit product format 808610010
Labeler code 80861
Product ID 80861-010_57f49614-d969-4a9c-e063-6394a90affea
Type HUMAN OTC DRUG
Nonproprietary name BENZOYL PEROXIDE
Dosage form KIT
Labeler AcneFree, LLC
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-12-01
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 SEVERE ACNE 24 HR Acne Clearing System
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106310 Internal RxNorm lookup 845836 Internal RxNorm lookup 2048989 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 80861-004-01 Acne Free SEVERE ACNE 24 HR Acne Clearing System 118 mL in 1 BOTTLE GEL 118 mL 25 mg in 1mL 6 80861-010-01 Acne Free SEVERE ACNE 24 HR Acne Clearing System 1 in 1 KIT KIT 1 6 80861-011-01 Acne Free SEVERE ACNE 24 HR Acne Clearing System 59 mL in 1 BOTTLE LOTION 59 mL 100 mg in 1mL 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80861-010 ACNE FREE SEVERE ACNE 24 HR ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [ACNEFREE, LLC] 5 Current NDC, Legacy NDC, 3 package rows 20240620_c939681e-ea93-31ce-e053-2a95a90a8c70.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 80861-004-01 80861000401 118 mL in 1 BOTTLE 118 ml Historical 80861-010-01 80861001001 1 KIT in 1 KIT (80861-010-01) * 118 mL in 1 BOTTLE (80861-004-01) * 59 mL in 1 BOTTLE (80861-011-01) 1 kit 2017-12-01 0000-00-00 No No Current 80861-011-01 80861001101 59 mL in 1 BOTTLE 59 ml Historical