FDA.reportPublic FDA data

Oil-Free Foaming Acne Wash Facial Cleanser

Product NDC
57337-033
11-digit product format
573370033
Labeler code
57337
Product ID
57337-033_126c057a-5b1d-c246-e063-6294a90a6936
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Rejoice International
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-21
Substance
SALICYLIC ACID
Active strength
4 mg/177mg
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
Oil-Free Foaming Acne Wash Facial Cleanser
Brand name suffix
Grapefruit
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID4 mg/177mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
562600Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a31baa57-1dfd-44d6-87a5-1b06377cb8b9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-033-012024-02-28C16284748780-11030e365-6028-111a-e063-dadaa90a10e2Oil-Free Foaming Acne Wash Facial Cleanser
57337-033-012024-01-30C16284748780-11030e365-6028-111a-e063-dadaa90a10e2Oil-Free Foaming Acne Wash Facial Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-033-01Oil-Free Foaming Acne Wash Facial CleanserGrapefruit177 mg in 1 BOTTLEGEL1773

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1
PROPYLENEINACTIVE INGREDIENTAUG1H506LYOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0ROIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-033OIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_a31baa57-1dfd-44d6-87a5-1b06377cb8b9.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 52 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne Fighting Spot with Aloe clearSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.db0054b1-29b9-48fa-8a02-86683bae81342023-11-21WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Clarifying Acne CleanserSALICYLIC ACIDGalderma Laboratories, L.P.9add83f2-7da6-4cd0-b91b-f6c937a562552023-11-20WarningsExact identifier
application number: M006
Dr. Gross AB Acne Daily BreakoutSALICYLIC ACIDTopiderm, Inc79d7f1f6-d08f-4be0-afc1-9ab4338a954d2023-11-20WarningsExact identifier
application number: M006
Dr. Dennis Gross Alpha Beta On the Spot EliminatorSALICYLIC ACIDTopiderm, Ince0dccdbc-56fd-4034-b479-f2a2ebde22342023-11-16WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Triple-Action Acne SerumSALICYLIC ACIDGalderma Laboratories, L.P.3e6eb59f-c523-460e-87ed-750b4a8cacac2023-11-16WarningsExact identifier
application number: M006
Medicated WashSALICYLIC ACIDVivier Pharma, Inc.e90ab8b6-6a77-4e02-9d71-45cd7383cb0a2023-11-14WarningsExact identifier
application number: M006
GOODBYE ACNE Complete treatment gelSALICYLIC ACIDPeter Thomas Roth, LLC09b88031-f5fe-8ae1-e063-6394a90a8a6a2023-11-14WarningsExact identifier
application number: M006
L BRI Pure n Natural Deep Clean TonerSALICYLIC ACIDL'BRI HEALTH AND BEAUTY INC353e948e-da5d-4c15-adcb-77ef978cf05f2023-11-11WarningsExact identifier
application number: M006
MD-Acne Body Acne TreatmentBENZOYL PEROXIDEMD Algorithms Inc.97981e9b-d56a-42f6-a75f-647b4732021e2023-11-11WarningsExact identifier
application number: M006
ACNE THERAPYBENZOYL PEROXIDEmenScience Androceuticals, LLC4dec259d-200e-44f2-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M006
HUMANE Acne Spot TreatmentBENZOYL PEROXIDEApprendista, LLCceeb398e-c516-45e4-a21c-cbecf6206fcc2023-11-11WarningsExact identifier
application number: M006
VANIBISS BUTT and THIGHS Acne Treatment CreamSALICYLIC ACIDVanibiss Inca0a75b54-e484-4e89-bdf2-e2c864cd27342023-11-11WarningsExact identifier
application number: M006
SIMPLY VITAL Acne Face CreamSALICYLIC ACIDALPHA PLANTS INC67c43d4a-873c-4b8e-83ff-6485d9633e7b2023-11-11WarningsExact identifier
application number: M006
CLARIFAST One Step Acne TreatmentSALICYLIC ACIDVIREO SYSTEMS, INC.b20a0f00-4bf2-4583-b399-7097542fff902023-11-11WarningsExact identifier
application number: M006
5 Percent Benzoyl Peroxide CleanserBENZOYL PEROXIDEBrand Evangelists for Beauty Limitede82469e2-606a-4263-9aaa-08596b59ff6b2023-11-10WarningsExact identifier
application number: M006
The INKEY List Acne Clearing MoisturizerSULFURBrand Evangelists for Beauty Limitedd26f5031-6592-4467-afc9-41c21f9f048c2023-11-10WarningsExact identifier
application number: M006
ACNE FORTE Acne Treatment CreamBENZOYL PEROXIDEGSCM Ventures Inc. DBA Revitolc29ed6c1-b8ad-4131-a94c-379f16ab2ee52023-11-10WarningsExact identifier
application number: M006
Meijer Blackhead Clearing Scrub Acne medicationSALICYLIC ACIDMeijer Distribution, Inc338e8937-e17e-4e14-b18f-2e63f55314422023-11-08WarningsExact identifier
application number: M006
Acne Fighting Foundation CaramelSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.92c4fe5f-fcc8-4dde-9f34-a55f53e009bb2023-11-06WarningsExact identifier
application number: M006
Asepxia Neutral Acne BarSALICYLIC ACIDGenomma Lab USAb3995e68-d364-4d96-8148-b456087b42972023-11-06WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSNa31baa57-1dfd-44d6-87a5-1b06377cb8b93
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCDa31baa57-1dfd-44d6-87a5-1b06377cb8b93
562600salicylic acid 2 % Facial Cleanser TonerSYa31baa57-1dfd-44d6-87a5-1b06377cb8b93
562600salicylic acid 2 % Facial ScrubSYa31baa57-1dfd-44d6-87a5-1b06377cb8b93
562600salicylic acid 2 % Medicated Liquid SoapSYa31baa57-1dfd-44d6-87a5-1b06377cb8b93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-033-0157337003301177 mg in 1 BOTTLE (57337-033-01) 177 mg2013-11-210000-00-00NoNoCurrent