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 27 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoyceDerm Sulfur Soap.SULFURRoyceDerm LLC3a323a77-eff4-973f-e063-6394a90a02a02025-07-18WarningsExact identifier
application number: M006
IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incfd92c669-997e-4eea-b883-fe3486b83f312025-07-15WarningsExact identifier
application number: M006
Blemish Blitz Emergency Acne SerumSALICYLIC ACIDGuangdong Joyan Biological Technology Co.,Ltd397a910a-c0ca-f5cb-e063-6394a90a3b9e2025-07-09WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication CleanserBENZOYL PEROXIDEL'Oreal USA Products Inccf49ed9b-8c1d-49f9-8c77-bb6a5abce9e42025-07-09WarningsExact identifier
application number: M006
La Roche Posay Effaclar Medicated CleanserSALICYLIC ACIDL'Oreal USA Products Inc4795cc87-c663-4702-b65d-ce85203f12582025-07-08WarningsExact identifier
application number: M006
Neutrogena Clear Pore Cleanser MaskBENZOYL PEROXIDEKenvue Brands LLCd020adb5-7f87-42c0-939d-99eb8744f65e2025-07-07WarningsExact identifier
application number: M006
Neutrogena Rapid Clear Acne Eliminating SpotSALICYLIC ACIDKenvue Brands LLC06804b81-db22-12ec-e063-6294a90a28e12025-07-07WarningsExact identifier
application number: M006
CeraVe Acne Clay-to-Foam CleanserSALICYLIC ACIDLOreal USA Products Inc3c4c2f52-0d37-4a3b-9a8d-2d54574b58d22025-06-26WarningsExact identifier
application number: M006
Freshiny Facial Cleanser Acne TreatmentSALICYLIC ACIDGuangdong Bawei Biotechnology Corporation4afe3a7e-8119-432a-b56a-34664d9b5a122025-06-24WarningsExact identifier
application number: M006
NAELI Exfoliator AHA BHA Face CleanserSALICYLIC ACIDALLI LLCe2a613c3-34f4-477e-99e6-67bcc7c117c42025-06-23WarningsExact identifier
application number: M006
Acne Treatment CreamACNE TREATMENT CREAMGuangzhou Yapeng Refinement Chemical Co., Ltd.37fc7d7f-da18-ac40-e063-6394a90abb5d2025-06-20WarningsExact identifier
application number: M006
Blemish Correcting SerumSALICYLIC ACIDTopiderm, Inc.84029bb8-a840-4b68-9a07-6838867332292025-06-17WarningsExact identifier
application number: M006
ACNE TREATMENT COTTON PADSACNE TREATMENT COTTON PADSGuangzhou Yapeng Refinement Chemical Co., Ltd.37ad7cd7-92df-82d9-e063-6294a90a0f042025-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION75e15ed6-e871-4dde-b7fc-145054626fa92025-06-12WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc2ac3a8c0-e0ed-435f-90fb-72c7a55a06732025-06-12WarningsExact identifier
application number: M006
Margarite Zinc CreamZINC CREAMRenu Laboratories, LLC3ca3b7d8-702a-036b-e054-00144ff8d46c2025-06-10WarningsExact identifier
application number: M006
Facial Cleansing WipesFACIAL CLEANSING WIPESShenzhen Shierjie Biological Engineering Co., LTD36f7677a-ec73-e677-e063-6294a90ad4802025-06-07WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incb36837e3-ea1c-41db-b52c-4175100895292025-06-05WarningsExact identifier
application number: M006
VENROCKSALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.349ae621-c832-128c-e063-6294a90a284d2025-06-05WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONbc9fffbc-c176-4d89-b1c6-294a8439a9302025-06-05WarningsExact 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