Home NDC 80861-010-01 Acne Free SEVERE ACNE 24 HR Acne Clearing System
Product NDC 80861-010
Requested package NDC 80861-010-01
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 45 of 54 · 1,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AL00761 Alba Botanica Acnedote Face and Body Scrub SALICYLIC ACID The Hain Celestial Group, Inc. c55efca6-5a5b-134b-e053-2a95a90a8245 2024-07-31 Warnings Exact identifier application number: M006 Gly-Sal 5-2 SALICYLIC ACID Topiderm, Inc. a75e4cee-678f-4e44-9e5e-bafae1c23f9b 2024-07-31 Warnings Exact identifier application number: M006 Face Reality Advanced Acne Med BENZOYL PEROXIDE Face Reality e1eb8496-0611-4dbc-befb-fb43ec164433 2024-07-26 Warnings Exact identifier application number: M006 Face Reality 5% Advanced Acne Med BENZOYL PEROXIDE Face Reality 0e52972d-b4d9-43f8-8dbb-2eec0782e0f7 2024-07-26 Warnings Exact identifier application number: M006 Face Reality 10% Advanced Acne Med BENZOYL PEROXIDE Face Reality a214ea15-6346-4729-ba84-fbc842faf92a 2024-07-26 Warnings Exact identifier application number: M006 Replenix Gly-Sal 2-2 SALICYLIC ACID Topiderm, Inc. 6c6bbedc-e2ee-46a0-8800-e356bdd262b0 2024-07-25 Warnings Exact identifier application number: M006 Thayers Since 1847 Natural Remedies Double Action Acne Serum SALICYLIC ACID L'Oreal USA Products Inc f9daadf9-a9d3-4f2d-af07-5f0b70f7803f 2024-07-17 Warnings Exact identifier application number: M006 BLEMISH DOTS - RETINOL (10 PATCHES) SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. c7164d75-75e7-494a-9595-028ecbf26276 2024-07-14 Warnings Exact identifier application number: M006 BLEMISH DOTS - CHARCOAL (10 PATCHES) SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. 286f642f-7359-41b9-9daf-e866a87fbefa 2024-07-14 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc 74c49388-3314-47e8-80b1-19c09e6ea1f9 2024-07-14 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION 873de079-8b8d-45cd-8c7c-4645818f5aaa 2024-07-14 Warnings Exact identifier application number: M006 Dr. Zenovia Clear Complexion SALICYLIC ACID Topiderm, Inc. 4ff9b26d-3cd9-4539-b389-edd2df24a466 2024-06-28 Warnings Exact identifier application number: M006 LEROSETT Botanical Acne Cleanser SALICYLIC ACID GUNILLA OF SWEDEN, INC. 8b31d155-c257-4452-9e22-0c69fa36173e 2024-06-27 Warnings Exact identifier application number: M006 SkinCeuticals Silymarin CF Acne Treatment Antioxidant SALICYLIC ACID Cosmetique Active Production fcc3c44b-3090-45b5-91e4-e591c92a08c8 2024-06-24 Warnings Exact identifier application number: M006 Peace Out Early Stage Acne Dot SALICYLIC ACID Peace Out LLC. 0632d458-d326-ade4-e063-6294a90af3ba 2024-06-20 Warnings Exact identifier application number: M006 Replenix BP Acne BENZOYL PEROXIDE Topiderm, Inc. f449e020-a4d8-4a1b-82eb-4dc59e99b8d4 2024-06-18 Warnings Exact identifier application number: M006 b pure Pressed Powder for Acne Prone Skin Fair SALICYLIC ACID Fourstar Group USA, Inc. ecf22bd1-4fc3-4455-ae01-13f97f53dc34 2024-06-17 Warnings Exact identifier application number: M006 b pure Pressed Powder for Acne Prone Skin Tan SALICYLIC ACID Fourstar Group USA, Inc. 1158f6c2-2b59-4ed3-8d28-73b6da885a5d 2024-06-17 Warnings Exact identifier application number: M006 Gly-Sal 10-2 SALICYLIC ACID Topiderm, Inc. 661cc58b-9360-4b96-b405-afdc2e378397 2024-06-13 Warnings Exact identifier application number: M006 BLAIR and JACK Anti-Bump Acne Treatment BENZOYL PEROXIDE Blair + Jack aa8df86a-639c-4416-aadf-4b58566ed9f1 2024-06-11 Warnings Exact identifier application number: M006
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 80861-010-01 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