FDA.reportPublic FDA data

Acne Clearing Sulfur Mask

Product NDC
80861-001
11-digit product format
808610001
Labeler code
80861
Product ID
80861-001_57f46155-bc18-0a68-e063-6394a90a95da
Type
HUMAN OTC DRUG
Nonproprietary name
SULFUR
Dosage form
CREAM
Route
TOPICAL
Labeler
AcneFree, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-01
Substance
SULFUR
Active strength
35 mg/g
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 Clearing Sulfur Mask
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR35 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70FD1KFU70Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1098781Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0675282-ff00-edba-e053-2995a90ace68Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80861-001-01Acne Clearing Sulfur Mask48 g in 1 TUBECREAM486
80861-001-01Acne Clearing Sulfur Mask1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80861-001ACNE CLEARING SULFUR MASK (SULFUR) CREAM [ACNEFREE, LLC]5Current NDC, Legacy NDC, 2 package rows20240620_c0675282-ff00-edba-e053-2995a90ace68.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 31 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Beauty Medicated Apricot Cleanser Acne MedicationSALICYLIC ACIDWALMART INC.2b94e93f-cdce-919a-e063-6294a90adc302025-01-14WarningsExact identifier
application number: M006
SUNDAY RILEY U.F.O Acne Treatment Face OilSALICYLIC ACIDSunday Riley Modern Skincare, LLC90bd3b3b-3b42-4369-8b9a-a81dd8b6a1e52025-01-14WarningsExact identifier
application number: M006
AcNe solutionSALICYLIC ACIDNoon Aesthetics M.R. Ltd04c048c6-4035-4599-a29e-ff3c7f58e58a2025-01-13WarningsExact identifier
application number: M006
SLMD Salicylic Acid Body WashSALICYLIC ACIDOwen Biosciences Inc.86b95f37-cef1-424b-87e0-9ed7eca5d2592025-01-13WarningsExact identifier
application number: M006
SLMD Silver Sulfur Acne CreamSULFUROwen Biosciences Inc.4735a6d6-bf87-404d-a46d-7f29fcff94092025-01-13WarningsExact identifier
application number: M006
Double FightSALICYLIC ACID AND BENZOYL PEROXIDENoon Aesthetics M.R. Ltd1fb83be2-6140-45e8-a95f-188f147a038d2025-01-13WarningsExact identifier
application number: M006
EradiKate ACNE TREATMENTSULFURKate Somerville Skincare, LLC713093d9-29c3-44c9-b90f-ee7448c5063e2025-01-12WarningsExact identifier
application number: M006
ERADIKATE ACNE MARK FADINGSALICYLIC ACIDKATE SOMERVILLE SKINCARE, LLC4378b359-8eb9-4095-a106-45e1107580992025-01-12WarningsExact identifier
application number: M006
EradiKate Daily Foaming Cleanser Acne TreatmentSULFURKate Somerville Skincare, LLCbebe3042-b80c-41ca-b8df-48093573c0822025-01-12WarningsExact identifier
application number: M006
Exuviance Daily Acne PeelSALICYLIC ACIDNeoStrata Company Inc.e9f7da8a-c595-4500-89f1-ec8a2a72ef592025-01-10WarningsExact identifier
application number: M006
Drs. ACNE CLEARSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACYd6faa57c-d081-b57c-e053-2a95a90a79262025-01-09WarningsExact identifier
application number: M006
innisfree Gentle Retinol Salicylic Acne SerumSALICYLIC ACID GELInnisfree Corporation2b38b6f2-0de5-581b-e063-6394a90acd552025-01-08WarningsExact identifier
application number: M006
Nutricentials Here You Glow Exfoliating TonerSALICYLIC ACIDNSE Products, Inc.ecf6c01b-50e5-4cfd-8ac3-0027cdc33f902025-01-07WarningsExact identifier
application number: M006
Zitlox Salicylic AcneSALICYLIC ACIDASA Universal Inc. dba: SONAGE4b833d7a-f957-4e65-be5b-1771493149582025-01-06WarningsExact identifier
application number: M006
glo SKIN BEAUTY Clear Skin CleanserGLO SKIN BEAUTY CLEAR SKIN CLEANSERHayden Caleel LLC07f51d83-e956-442c-9afa-aa987a66ae9e2025-01-05WarningsExact identifier
application number: M006
glo SKIN BEAUTY Clear Skin Spot TreatmentGLO SKIN BEAUTY CLEAR SKIN SPOT TREATMENTHayden Caleel LLC9f33ffc7-2727-491e-a361-7f130c81d1b12025-01-05WarningsExact identifier
application number: M006
Acne Defense Face WashSALICYLIC ACIDPacifica Beauty, LLCf43590c7-84c0-6eb8-e053-2a95a90a01a72025-01-03WarningsExact identifier
application number: M006
Acne Warrior Body ScrubSALICYLIC ACIDPacifica Beauty, LLCf44a4fc5-3358-5966-e053-2995a90add562025-01-03WarningsExact identifier
application number: M006
Acne Warrior Body WashSALICYLIC ACIDPacifica Beauty, LLCf45b4c77-45a3-f480-e053-2995a90a36be2025-01-03WarningsExact identifier
application number: M006
Acne Warrior Clearing AstringentSALICYLIC ACIDPacifica Beauty, LLCf44bcd96-dbf8-5718-e053-2a95a90adc342025-01-03WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098781sulfur 3.5 % Medicated Liquid SoapPSNc0675282-ff00-edba-e053-2995a90ace686
1098781sulfur 35 MG/ML Medicated Liquid SoapSCDc0675282-ff00-edba-e053-2995a90ace686
1098781sulfur 3.5 % Facial MaskSYc0675282-ff00-edba-e053-2995a90ace686

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80861-001-01808610001011 TUBE in 1 CARTON (80861-001-01) / 48 g in 1 TUBE1 tube2017-12-010000-00-00NoNoCurrent