FDA.reportPublic FDA data

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
IdentifierFDA.report destination
1234456Internal RxNorm lookup
1548871Internal RxNorm lookup
1549098Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9397a25-8fed-48d0-e053-2a95a90ab495Available 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
80861-007-01Acne Free SENSITIVE SKIN 24 HR Acne Clearing System1 in 1 KITKIT16
80861-008-01Acne Free SENSITIVE SKIN 24 HR Acne Clearing System118 mL in 1 BOTTLELOTION118 mL15 mg in 1mL6
80861-009-01Acne Free SENSITIVE SKIN 24 HR Acne Clearing System59 mL in 1 BOTTLELOTION59 mL30 mg in 1mL6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80861-007ACNE FREE SENSITIVE SKIN 24 HR ACNE CLEARING SYSTEM (SALICYLIC ACID, BENZOYL PEROXIDE) KIT [ACNEFREE LLC]5Current NDC, Legacy NDC, 3 package rows20240620_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 15 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Peace Out Acne SerumSALICYLIC ACIDPeace Out LLC.7cd68513-0470-4409-82d0-619c97e69ff42026-01-14WarningsExact identifier
application number: M006
MEDPURA Benzoyl PeroxideBENZOYL PEROXIDEAkron Pharma Inc.1b051efe-054b-42a0-915a-b87885bd3c542026-01-13WarningsExact identifier
application number: M006
END-ZITSULFURABBE Laboratories, Inc.afed5e8e-324c-44c6-abf6-72938376a4b22026-01-13WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne WashSALICYLIC ACIDKenvue Brands LLCc4775032-9723-4208-8a42-145f2b4da1c82026-01-12WarningsExact identifier
application number: M006
BHA CLEANSER 2%SALICYLIC ACIDSkinfix, Inc.ceccb599-ff9e-fc87-e053-2a95a90a411a2026-01-12WarningsExact identifier
application number: M006
ACNE SPOT TREATMENT 2% BHASALICYLIC ACIDSkinfix, Inc.ceccea68-07d8-0903-e053-2995a90ab2b72026-01-12WarningsExact identifier
application number: M006
Sulfo loSULFUR 3% SOAP BARCrown Laboratories89577417-76a0-cb04-e053-2995a90a57332026-01-12WarningsExact identifier
application number: M006
PanOxylBENZOYL PEROXIDECrown Laboratories1660f219-e789-91f1-e063-6294a90a76642026-01-12WarningsExact identifier
application number: M006
PanOxylBENZOYL PEROXIDECrown Laboratoriesff09cbab-304b-4da9-e053-6394a90ae6002026-01-12WarningsExact identifier
application number: M006
PanOxyl Clarifying ExfoliantSALICYLIC ACIDCrown Laboratories, Inc.faa6576c-2af2-d86b-e053-6294a90ada2d2026-01-12WarningsExact identifier
application number: M006
PanOxylBENZOYL PEROXIDECrown Laboratories7b301b94-3cc8-b05b-e053-2991aa0aa5612026-01-12WarningsExact identifier
application number: M006
PanOxyl Acne Gel WashSALICYLIC ACIDCrown Laboratories, Inc.39712bb8-3d4e-29b3-e063-6394a90a95b82026-01-12WarningsExact identifier
application number: M006
Proactiv Clean Mineral Acne CleanserSULFURAlchemee, LLC380d0f8f-8d31-41b9-9d5f-8a35f7f81b5b2026-01-07WarningsExact identifier
application number: M006
Proactiv Clean Acne Clearing HydratorSALICYLIC ACIDAlchemee, LLC33ac397c-55af-4a50-b5ce-80f8a88015812026-01-07WarningsExact identifier
application number: M006
Proactiv CLEAR ZONE BODY PADSSALICYLIC ACIDAlchemee, LLCcf9e5536-08f6-4bbd-9e09-2e9a0c768ed92026-01-07WarningsExact identifier
application number: M006
Proactiv Plus Complexion Perfecting HydratorSALICYLIC ACIDAlchemee, LLCc9b91b61-738e-474e-927f-0806264c739e2026-01-07WarningsExact identifier
application number: M006
Proactiv plus Pore Targeting TreatmentBENZOYL PEROXIDEAlchemee, LLC12f2eeab-d258-4eb1-8fe2-784c51c2e4cc2026-01-07WarningsExact identifier
application number: M006
Proactiv Plus Retexturizing TonerSALICYLIC ACIDAlchemee, LLC7c211ff7-920f-407b-ad8d-60d14803b8572026-01-07WarningsExact identifier
application number: M006
Proactiv Clarifying NightSALICYLIC ACIDAlchemee, LLC8b81b4e5-f2fc-45a1-923a-7c326529d68b2026-01-07WarningsExact identifier
application number: M006
Proactiv Emergency Blemish ReliefBENZOYL PEROXIDEAlchemee, LLC72bb45ca-3f68-47be-928e-755cc66419d92026-01-07WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1549098{1 (59 ML) (benzoyl peroxide 30 MG/ML Topical Lotion) / 1 (118 ML) (salicylic acid 15 MG/ML Medicated Liquid Soap) } PackGPCKc9397a25-8fed-48d0-e053-2a95a90ab4956
1548871benzoyl peroxide 3 % Topical LotionPSNc9397a25-8fed-48d0-e053-2a95a90ab4956
1549098benzoyl peroxide 3 % Topical Lotion (59 ML) / salicylic acid 1.5 % Medicated Liquid Soap (118 ML) PackPSNc9397a25-8fed-48d0-e053-2a95a90ab4956
1234456salicylic acid 1.5 % Medicated Liquid SoapPSNc9397a25-8fed-48d0-e053-2a95a90ab4956
1548871benzoyl peroxide 30 MG/ML Topical LotionSCDc9397a25-8fed-48d0-e053-2a95a90ab4956
1234456salicylic acid 15 MG/ML Medicated Liquid SoapSCDc9397a25-8fed-48d0-e053-2a95a90ab4956
1234456salicylic acid 1.5 % Medicated Liquid SoapSYc9397a25-8fed-48d0-e053-2a95a90ab4956

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80861-007-01808610007011 KIT in 1 KIT (80861-007-01) * 118 mL in 1 BOTTLE (80861-008-01) * 59 mL in 1 BOTTLE (80861-009-01) 1 kit2017-12-010000-00-00NoNoCurrent
80861-008-0180861000801118 mL in 1 BOTTLE118 mlHistorical
80861-009-018086100090159 mL in 1 BOTTLE59 mlHistorical