FDA.reportPublic FDA data

Oil-Free Foaming Acne Wash Facial Cleanser

Product NDC
57337-034
11-digit product format
573370034
Labeler code
57337
Product ID
57337-034_126c1352-8e10-57d9-e063-6294a90abe83
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
2026-12-31
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
Tea Tree Oil
Listing expiration
2026-12-31

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
7ae434d1-8b07-4121-9163-df07598d4156Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-034-012024-02-28C16284748780-11030e365-4133-111a-e063-dadaa90a10e2Oil-Free Foaming Acne Wash Facial Cleanser
57337-034-012024-01-30C16284748780-11030e365-4133-111a-e063-dadaa90a10e2Oil-Free Foaming Acne Wash Facial Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-034-01Oil-Free Foaming Acne Wash Facial CleanserTea Tree Oil177 mg in 1 BOTTLEGEL1775

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3
WATERINACTIVE INGREDIENT059QF0KO0ROIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-034OIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]5Current NDC, Legacy NDC, 1 package rows20240229_7ae434d1-8b07-4121-9163-df07598d4156.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 9 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0bab0a-28cb-effa-e063-6294a90a4be32026-04-09WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Wash Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0bb7c0-3c08-02cd-e063-6294a90a67492026-04-09WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0bb38a-765b-d072-e063-6294a90a8d4d2026-04-09WarningsExact identifier
application number: M006
ageLOC LumiSpa Treatment Cleanser AcneSALICYLIC ACIDNSE Products, Inc7f478ae8-8b97-4cdf-a023-cea14b992ff92026-04-03WarningsExact identifier
application number: M006
Anew Bare Acne Clearing Treatment 2% Salicylic AcidSALICYLIC ACIDTHE AVON COMPANY4e7d1429-0498-5812-e063-6394a90a4d4d2026-04-02WarningsExact identifier
application number: M006
UNBLEMISH 30-Day RegimenSALICYLIC ACID, BENZOYL PEROXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERodan & Fieldse9a52ccc-6ba0-4417-86cc-b2116a5b8d262026-04-01WarningsExact identifier
application number: M006
ageLOC LumiSpa Blemish SerumSALICYLIC ACIDNSE Products, Inc.35cdc16c-9a51-4ee9-b39d-36f29c4176ae2026-04-01WarningsExact identifier
application number: M006
UNBLEMISH Refining Acne WashSALICYLIC ACIDRodan & Fields08922efa-5a90-4dfb-b9f4-a6c4f8dba3c92026-03-31WarningsExact identifier
application number: M006
purity made simpleSALICYLIC ACIDPhilosophy, Inc.ed785dc1-a1a2-4e89-a4f7-2d0eef3ca2bb2026-03-31WarningsExact identifier
application number: M006
UNBLEMISH Dual Intensive Acne TreatmentBENZOYL PEROXIDERodan & Fields27ea743c-e080-487d-adc5-e31176f5b9fc2026-03-30WarningsExact identifier
application number: M006
SPESOLSKII MILIA REMOVER ESSENCESALICYLIC ACID 1% MILIA REMOVER ESSENCEBEST GREEN LIMITED4e35f848-2e9c-d0c6-e063-6294a90a8d4b2026-03-29WarningsExact identifier
application number: M006
Purito Acne Intensive TreatmentSALICYLIC ACIDHinature Inc.ca5ab57f-ddcb-4ced-8dd3-a698ad2d17de2026-03-26WarningsExact identifier
application number: M006
Oxy Vitamin C SerumSALICYLIC ACID 0.5%The Mentholatum Company2a34ceef-d442-1c2d-e063-6294a90a66392026-03-25WarningsExact identifier
application number: M006
Oxy Sensitive Skin Acne Cream CleanserBENZOYL PEROXIDE 5%The Mentholatum Company288da995-eda8-5d1c-e063-6394a90a38b22026-03-25WarningsExact identifier
application number: M006
Salicylic Face and Body WashSALICYLIC ACID SOAPCosMedical Technologies23b72e5e-9bc3-01d3-e054-00144ff8d46c2026-03-25WarningsExact identifier
application number: M006
Oxy Deep Pore Acne Cleansing PadsSALICYLIC ACIDThe Mentholatum Company4dde8b03-84e2-5ec7-e063-6394a90a69102026-03-25WarningsExact identifier
application number: M006
Rael Beauty Miracle Clear Complete Acne SerumSALICYLIC ACIDRael, Inc.fdb7ecd2-c4c8-90b6-e053-6294a90a69b12026-03-25WarningsExact identifier
application number: M006
JTOPYRTSALICYLIC ACID PADGuangzhou Yixiang Trading Co., Ltd.3dfb8f94-f734-de7d-e063-6394a90abed82026-03-25WarningsExact identifier
application number: M006
Tula Skincare Clear Skin Starters Travel Size Acne and Blemish Fighting KitSALICYLIC ACIDThe Procter & Gamble Manufacturing Company4dc9e3eb-c4d0-b5e1-e063-6394a90a9b7e2026-03-24WarningsExact identifier
application number: M006
Oxy 3-IN-1 Acne Cleansing PadsSALICYLIC ACIDThe Mentholatum Company4dcc9f0a-24d0-d62e-e063-6394a90aafe22026-03-24WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN7ae434d1-8b07-4121-9163-df07598d41565
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD7ae434d1-8b07-4121-9163-df07598d41565
562600salicylic acid 2 % Facial Cleanser TonerSY7ae434d1-8b07-4121-9163-df07598d41565
562600salicylic acid 2 % Facial ScrubSY7ae434d1-8b07-4121-9163-df07598d41565
562600salicylic acid 2 % Medicated Liquid SoapSY7ae434d1-8b07-4121-9163-df07598d41565

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-034-0157337003401177 mg in 1 BOTTLE (57337-034-01) 177 mg2013-11-210000-00-00NoNoCurrent