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 12 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PoreFectSALICYLIC ACIDOur-Science Inc.4afe4115-cdf0-6dd3-e063-6394a90a24532026-02-16WarningsExact identifier
application number: M006
iShancare Folliculitis CreamFOLLICULITIS CREAMShenzhen Ishan Technology Co., Ltd0c85c8e9-f50f-1b72-e063-6394a90a88c42026-02-13WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDETopco Associates LLC8d5e7e40-5e61-470a-b8ff-0b2dca3cabb02026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Daily Acne Control CleanserBENZOYL PEROXIDETopco Associates LLC8474d917-7ee4-4d1d-8499-3520f771d2fd2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Body WashSALICYLIC ACIDTopco Associates LLC1b16b978-70e0-4bba-a8d7-a77d7e1f896a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDTopco Associates LLCe98a8184-c5a8-4306-9fff-9dc77e9d2d442026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Salicylic AcidASTRINGENTTopco Associates LLC7d15560f-d8d1-4dfe-8eca-b16bb529ad872026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Topco Associates LLC3149260c-b92b-43a7-8f57-897517102fa82026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEWalgreen Co.07721aa6-867a-436f-8c88-ab135f02a6b52026-02-12Warnings, Adverse reactionsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDAmazon.com Services LLC06339296-14e7-4179-aa2f-538bae921a8b2026-02-11Warnings, Adverse reactionsExact identifier
application number: M006
natouchSALICYLIC ACIDNatouch LLC3af85c98-f14d-5857-e063-6394a90aed132026-02-10WarningsExact identifier
application number: M006
ACNE TREATMENTTREATBio Clarity LLC4a7e40c1-7421-a0c7-e063-6294a90a4d6b2026-02-10WarningsExact identifier
application number: M006
HerbaGlow Baiwooxia Anti-Acne GelSALICYLIC ACID GELKungpo Health Care & Herbal Center Inc010029a3-8c1a-4f29-a162-a8ba4f9390582026-02-10WarningsExact identifier
application number: M006
Acne CleanserBENZOYL PEROXIDEWalmart, Inc.04514cbb-6041-4bd5-9ab9-31312b0d8f192026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Salicylic acidSALICYLIC ACIDTopco Associates LLC4a28800d-14ef-d841-e063-6394a90a692b2026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDRetail Business Services, LLC1942bd34-a152-450e-a5c5-46488da66b3d2026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%American Sales Company613f0a91-32d3-4a1e-9c9f-f0167481b5112026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
ACNE DOTS (Skin Care Multi-Pack)SALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.4a0dc951-07ce-2030-e063-6294a90ab2ea2026-02-05WarningsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Publix Super Markets, Inc.169eaaa4-308d-44ba-ad93-3205e0dd9ae12026-02-05Warnings, Adverse reactionsExact identifier
application number: M006
SPOTLESS Daily Acne WashBENZOYL PEROXIDERodan & Fields8f7bb793-3c60-4014-954e-514ef87a44fb2026-02-04WarningsExact 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