FDA.reportPublic FDA data

Acne Body Wash

Product NDC
57337-030
11-digit product format
573370030
Labeler code
57337
Product ID
57337-030_126babfe-2f76-9f6c-e063-6294a90ae8e7
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
2013-11-18
Substance
SALICYLIC ACID
Active strength
7 mg/354mg
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 Body Wash
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID7 mg/354mg

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
97369cca-735a-425f-a0bc-00bc07691465Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-030-012024-02-28C16284748780-11030e365-126c-111a-e063-dadaa90a10e2Acne Body Wash
57337-030-012024-01-30C16284748780-11030e365-126c-111a-e063-dadaa90a10e2Acne Body Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-030-01Acne Body Wash354 mg in 1 BOTTLEGEL3546

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
DISODIUM COCOAMPHODIACETATEINACTIVE INGREDIENT18L9G3U51MACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4
WATERINACTIVE INGREDIENT059QF0KO0RACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-030ACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]6Current NDC, Legacy NDC, 1 package rows20240229_97369cca-735a-425f-a0bc-00bc07691465.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 32 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Dry It Out Acne Spot TreatmentSALICYLIC ACIDPacifica Beauty, LLCf44c0be7-9565-0068-e053-2a95a90a97052025-01-03WarningsExact identifier
application number: M006
Pacifica Bacne WarriorSALICYLIC ACIDPacifica Beauty, LLCf2b77c4f-f181-76cb-e053-2995a90a6cc12025-01-03WarningsExact identifier
application number: M006
Clarifying BacneSALICYLIC ACIDDermalogica, LLC.eb13bf93-2554-4666-bd74-637b2eed7b502025-01-02WarningsExact identifier
application number: M006
CLN ACNE CLEANSERSALICYLIC ACID 0.5% LIQUIDTopMD Skin Care, Inc.1b2f4718-b174-9b50-e063-6394a90ac2f42025-01-02WarningsExact identifier
application number: M006
Biore Witch Hazel Pore Clarifying CleanserSALICYLIC ACIDKao USA Inc.7c107414-457b-1ab0-e053-2991aa0af55a2025-01-01WarningsExact identifier
application number: M006
Biore Blemish Fighting Ice CleanserSALICYLIC ACIDKao USA Inc.e105ed47-d161-4563-a05f-f2e245659aee2025-01-01WarningsExact identifier
application number: M006
CLENZIDERM PORE THERAPY ACNE TREATMENTSALICYLIC ACIDObagi Cosmeceuticals LLC08c1a55e-a376-4cd6-896f-0ad2068a1fc02025-01-01WarningsExact identifier
application number: M006
CLENZIDERM THERAPEUTIC MOISTURIZERGLYCERINObagi Cosmeceuticals LLCd60e22e3-831e-4787-a82c-e7763c2875532025-01-01WarningsExact identifier
application number: M006
CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENTSALICYLIC ACIDObagi Cosmeceuticals LLC268bf278-3f18-4410-b552-25baadb9f96c2025-01-01WarningsExact identifier
application number: M006
CLENZIDERM THERAPEUTICBENZOYL PEROXIDEObagi Cosmeceuticals LLCf0ad29b6-38b0-4118-a711-3c668ac801ec2025-01-01WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAY2a932c8f-3a48-dfcd-e063-6394a90ac20b2024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAY2a9315ce-f4da-6a1e-e063-6294a90a8f422024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAY2a92bd47-0d91-00b9-e063-6294a90ae1d62024-12-31WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN97369cca-735a-425f-a0bc-00bc076914656
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD97369cca-735a-425f-a0bc-00bc076914656
562600salicylic acid 2 % Facial Cleanser TonerSY97369cca-735a-425f-a0bc-00bc076914656
562600salicylic acid 2 % Facial ScrubSY97369cca-735a-425f-a0bc-00bc076914656
562600salicylic acid 2 % Medicated Liquid SoapSY97369cca-735a-425f-a0bc-00bc076914656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-030-0157337003001354 mg in 1 BOTTLE (57337-030-01) 354 mg2013-11-180000-00-00NoNoCurrent