Home NDC 80861-007 Acne Free SENSITIVE SKIN 24 HR Acne Clearing System
Product NDC 80861-007
11-digit product format 808610007
Labeler code 80861
Product ID 80861-007_57f49764-1d1b-4b35-e063-6394a90a81db
Type HUMAN OTC DRUG
Nonproprietary name SALICYLIC ACID, 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 SENSITIVE SKIN 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 1234456 Internal RxNorm lookup 1548871 Internal RxNorm lookup 1549098 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 80861-007-01 Acne Free SENSITIVE SKIN 24 HR Acne Clearing System 1 in 1 KIT KIT 1 6 80861-008-01 Acne Free SENSITIVE SKIN 24 HR Acne Clearing System 118 mL in 1 BOTTLE LOTION 118 mL 15 mg in 1mL 6 80861-009-01 Acne Free SENSITIVE SKIN 24 HR Acne Clearing System 59 mL in 1 BOTTLE LOTION 59 mL 30 mg in 1mL 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80861-007 ACNE FREE SENSITIVE SKIN 24 HR ACNE CLEARING SYSTEM (SALICYLIC ACID, BENZOYL PEROXIDE) KIT [ACNEFREE LLC] 5 Current NDC, Legacy NDC, 3 package rows 20240620_c9397a25-8fed-48d0-e053-2a95a90ab495.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 55 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Replenix Acne Gly-Sal 2-2 Foaming Cleanser SALICYLIC ACID Topiderm, Inc. 811dbf95-2b39-45c5-99a2-33c3c9d19570 2019-12-19 Warnings Exact identifier application number: M006 REPLENIX ACNE SOLUTIONS WASH BENZOYL PEROXIDE Topiderm, Inc. 8dc2d27d-3cc4-4874-b4c2-32607849b205 2019-12-17 Warnings Exact identifier application number: M006 REPLENIX ACNE Solution BENZOYL PEROXIDE WASH BENZOYL PEROXIDE Topiderm, Inc. 235e9dd5-13f2-4078-9807-1d87fd9e6cba 2019-12-17 Warnings Exact identifier application number: M006 Replenix Acne BENZOYL PEROXIDE Topiderm, Inc 03d4c298-8f44-41f7-b086-96ae836152bb 2019-10-31 Warnings Exact identifier application number: M006 Replenix Acne BENZOYL PEROXIDE Topiderm, Inc. c12f9005-a549-4447-9beb-df7126f77df1 2019-10-31 Warnings Exact identifier application number: M006 Gly-Sal 10-2 Pads SALICYLIC ACID Topiderm, Inc. b39e845d-4c40-4f9e-9cb5-a8386f326652 2019-10-23 Warnings Exact identifier application number: M006 Gly-Sal 5-2 Pads SALICYLIC ACID Topiderm, Inc. e73bd26c-cdc2-47ab-94e8-3bc49a9b19e8 2019-10-22 Warnings Exact identifier application number: M006 SKIN MEDICA Purifying Foaming Wash SALICYLIC ACID Allergan, Inc. 064d9e2b-077f-4229-b653-666fc5479ae2 2013-03-01 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 80861-007-01 80861000701 1 KIT in 1 KIT (80861-007-01) * 118 mL in 1 BOTTLE (80861-008-01) * 59 mL in 1 BOTTLE (80861-009-01) 1 kit 2017-12-01 0000-00-00 No No Current 80861-008-01 80861000801 118 mL in 1 BOTTLE 118 ml Historical 80861-009-01 80861000901 59 mL in 1 BOTTLE 59 ml Historical