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 45 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join amazon basics step 1 cleanser Acne treatment BENZOYL PEROXIDE AMAZON.COM SERVICES LLC 23a060f0-d379-4370-9a79-ca6e854419b4 2024-08-26 Warnings Exact identifier application number: M006 SEYTU Spot SALICYLIC ACID Omnilife USA, Inc. 68252aa0-36cd-4380-8898-16a5e4731866 2024-08-23 Warnings Exact identifier application number: M006 Peach Slices 3 Step Acne Starter Kit SALICYLIC ACID Peach & Lily, Inc 0c8860ca-5376-4e98-a7a9-4668dff4f0aa 2024-08-14 Warnings Exact identifier application number: M006 PHARMA CLEAR CLEANSER SALICYLIC ACID PHARMAGEL INTERNATIONAL INC d2c39d80-5ccd-43a8-a8bf-eba502bfdbf1 2024-08-13 Warnings Exact identifier application number: M006 PHARMA CLEAR MOISTURIZER SALICYLIC ACID PHARMAGEL INTERNATIONAL INC c4c08475-bafa-4bb1-92a5-e94e60086264 2024-08-13 Warnings Exact identifier application number: M006 PHARMA CLEAR ACNE TREATMENT SALICYLIC ACID PHARMAGEL INTERNATIONAL INC 6d94f911-d751-45e4-b24d-8d85c6a3cefb 2024-08-13 Warnings Exact identifier application number: M006 Anti-Everything Face Serum SALICYLIC ACID SERUM Bentley laboratories, llC 8330e61c-50ec-44a5-91d9-a97e5a9d0388 2024-08-05 Warnings Exact identifier application number: M006 Anti-Everything Face Moisturizer SALICYLIC ACID CREAM Bentley Laboratories, LLC 36cb28f2-2620-4b88-811f-a2d6c1e22e79 2024-08-05 Warnings Exact identifier application number: M006 Tucks Medicated Cooling Pads WITCH HAZEL Blistex Inc 1eb3c742-7104-7b47-e063-6394a90a84ba 2024-08-02 Warnings Exact identifier application number: M006 Replenix Gly-Sal 10-2 cleanser SALICYLIC ACID Topiderm, Inc. 00d1f8af-88de-4a14-80ec-5ee9fd38b191 2024-08-02 Warnings Exact identifier application number: M006 AL0076001 Alba Botanica Acnedote Deep Pore Wash SALICYLIC ACID The Hain Celestial Group, Inc. 6157c9c6-f252-5b49-e053-2991aa0ad8ed 2024-07-31 Warnings Exact identifier application number: M006 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
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