FDA.reportPublic FDA data

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
IdentifierFDA.report destination
106310Internal RxNorm lookup
845836Internal RxNorm lookup
2048989Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c939681e-ea93-31ce-e053-2a95a90a8c70Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80861-004-01Acne Free SEVERE ACNE 24 HR Acne Clearing System118 mL in 1 BOTTLEGEL118 mL25 mg in 1mL6
80861-010-01Acne Free SEVERE ACNE 24 HR Acne Clearing System1 in 1 KITKIT16
80861-011-01Acne Free SEVERE ACNE 24 HR Acne Clearing System59 mL in 1 BOTTLELOTION59 mL100 mg in 1mL6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80861-010ACNE FREE SEVERE ACNE 24 HR ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [ACNEFREE, LLC]5Current NDC, Legacy NDC, 3 package rows20240620_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 41 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avene Cleanance Acne Medicated Clearing TreatmentBENZOYL PEROXIDEPierre Fabre USA Inc.facb99a0-f67e-80bf-e053-6294a90a23322024-11-06WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEA-S Medication Solutionsa86ae901-53d0-4bfd-808e-59d9a7bc5ef62024-11-06WarningsExact identifier
application number: M006
Meijer Acne Treatment Acne medicationBENZOYL PEROXIDEMeijer Distribution, Incf008ad20-03d0-45ae-8f75-249310eb9e702024-11-06WarningsExact identifier
application number: M006
Meijer Invisible Acne Acne medicationBENZOYL PEROXIDEMeijer Distribution, Inc2a6ec3dd-572d-4314-afbf-23aff0d1e22a2024-11-06WarningsExact identifier
application number: M006
Aveeno CLEAR COMPLEXION foaming cleanserSALICYLIC ACIDKenvue Brands LLC32425c63-7ed9-401b-a271-988b52b4f1052024-11-05WarningsExact identifier
application number: M006
Vivant Sulfur Clay MaskSULFURVivant Pharmaceuticals, LLC10cd9db0-5388-b671-e063-6394a90af50d2024-11-05WarningsExact identifier
application number: M006
Vivant BP10% Gel MedicationBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10cc63b8-b4f9-6a78-e063-6294a90aade42024-11-05WarningsExact identifier
application number: M006
Vivant BP3% Exfoliating CleanserBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10be3c7d-d09c-53a7-e063-6294a90a4f092024-11-05WarningsExact identifier
application number: M006
Vivant BP3% Acne WashBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10bf5723-225f-67d7-e063-6394a90a72b12024-11-05WarningsExact identifier
application number: M006
Meijer oil Free Acne Wash Facial Cleanser Pink Grapefruit Acne medicationSALICYLIC ACIDMeijer Distribution, Inc3232b833-225f-429f-910c-d11874f3f1d52024-11-05WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Stress Control Triple Action TonerSALICYLIC ACIDKenvue Brands LLC817a9746-df57-4b11-b580-f57fe9940a682024-11-01WarningsExact identifier
application number: M006
SkinMedica Acne Clarifying TreatmentSALICYLIC ACIDAllergan, Inc.664d4733-e72d-410a-8ed0-a159d9dfa2362024-11-01WarningsExact identifier
application number: M006
Walgreens Acne Control Cleanser Acne MedicationBENZOYL PEROXIDEWalgreen Companyf33e4204-fed9-4f14-a00f-c81b1910254b2024-10-31WarningsExact identifier
application number: M006
Walgreens Acne Foaming Wash Acne MedicationBENZOYL PEROXIDEWalgreen Companyf34affe9-d470-48a5-b0d1-d62b9c44b3f22024-10-31WarningsExact identifier
application number: M006
Clearing Skin WashSALICYLIC ACIDDermalogica, LLC.5cd31221-d6b4-47b9-99fd-fdfc2e1b6fdf2024-10-30WarningsExact identifier
application number: M006
Walgreens Acne Foaming Cleanser Acne TreatmentBENZOYL PEROXIDEWalgreen Company5b6fab38-4a9e-4c5c-967e-e3a0ff03b6062024-10-30WarningsExact identifier
application number: M006
ZO Skin Health Acne Control Benzoyl PeroxideBENZOYL PEROXIDEZO Skin Health, Inc.252b2352-a457-4009-a62b-0ec98f018b2e2024-10-28WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd9702add4-ea36-4c6b-9402-87b44f989a802024-10-23WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd7441981a-654d-4f18-be21-66c863ee6d6f2024-10-23WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f2024-10-23WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048989{1 (59 ML) (benzoyl peroxide 100 MG/ML Topical Lotion) / 1 (118 ML) (benzoyl peroxide 25 MG/ML Medicated Liquid Soap) } PackGPCKc939681e-ea93-31ce-e053-2a95a90a8c706
106310benzoyl peroxide 10 % Topical LotionPSNc939681e-ea93-31ce-e053-2a95a90a8c706
845836benzoyl peroxide 2.5 % Medicated Liquid SoapPSNc939681e-ea93-31ce-e053-2a95a90a8c706
2048989benzoyl peroxide 2.5 % Medicated Liquid Soap (4 OZ) / benzoyl peroxide 10 % Topical Lotion (2 OZ) PackPSNc939681e-ea93-31ce-e053-2a95a90a8c706
106310benzoyl peroxide 100 MG/ML Topical LotionSCDc939681e-ea93-31ce-e053-2a95a90a8c706
845836benzoyl peroxide 25 MG/ML Medicated Liquid SoapSCDc939681e-ea93-31ce-e053-2a95a90a8c706
106310benzoyl peroxide 10 % Topical LotionSYc939681e-ea93-31ce-e053-2a95a90a8c706
845836benzoyl peroxide 2.5 % Medicated Liquid SoapSYc939681e-ea93-31ce-e053-2a95a90a8c706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80861-004-0180861000401118 mL in 1 BOTTLE118 mlHistorical
80861-010-01808610010011 KIT in 1 KIT (80861-010-01) * 118 mL in 1 BOTTLE (80861-004-01) * 59 mL in 1 BOTTLE (80861-011-01) 1 kit2017-12-010000-00-00NoNoCurrent
80861-011-018086100110159 mL in 1 BOTTLE59 mlHistorical