FDA.reportPublic FDA data

XtraCare Deep Cleaning Astringent

Product NDC
57337-035
11-digit product format
573370035
Labeler code
57337
Product ID
57337-035_126cda9b-1f5b-3a25-e063-6294a90a691c
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
2013-11-26
Substance
SALICYLIC ACID
Active strength
5 mg/237mg
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
XtraCare Deep Cleaning Astringent
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID5 mg/237mg

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
346298Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
20cb8584-8a31-40a8-8a47-d9fa8ec8abcfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-035-012024-02-28C16284748780-11030e365-3cf6-111a-e063-dadaa90a10e2XtraCare Deep Cleaning Astringent
57337-035-012024-01-30C16284748780-11030e365-3cf6-111a-e063-dadaa90a10e2XtraCare Deep Cleaning Astringent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-035-01XtraCare Deep Cleaning Astringent237 mg in 1 BOTTLEGEL2374

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZXTRACARE DEEP CLEANING ASTRINGENT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZXTRACARE DEEP CLEANING ASTRINGENT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MXTRACARE DEEP CLEANING ASTRINGENT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE DEEP CLEANING ASTRINGENT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LXTRACARE DEEP CLEANING ASTRINGENT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]2
POLYOXYL 40 CASTOR OILINACTIVE INGREDIENT4ERD2076EFXTRACARE DEEP CLEANING ASTRINGENT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]2
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE DEEP CLEANING ASTRINGENT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-035XTRACARE DEEP CLEANING ASTRINGENT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4Current NDC, Legacy NDC, 1 package rows20240229_20cb8584-8a31-40a8-8a47-d9fa8ec8abcf.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 6 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlowBiotic Probiotic Acne CleanserSALICYLIC ACIDGlowbiotics546334bf-cf47-a1e5-e063-6394a90a590c2026-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5464d48b-495c-e45f-e063-6394a90aedfc2026-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION54650326-1582-26b7-e063-6394a90a575c2026-06-16WarningsExact identifier
application number: M006
Butterflys tear MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD52226dfd-eafa-42d7-e063-6394a90a16ef2026-06-12WarningsExact identifier
application number: M006
Proven Acne CleanserSALICYLIC ACIDProven Skincare316702b8-4f9d-0a42-e063-6394a90ad8e12026-06-11WarningsExact identifier
application number: M006
Proven Acne CleanserSALICYLIC ACIDProven Skincare31a29bdd-a218-247a-e063-6294a90a8cee2026-06-11WarningsExact identifier
application number: M006
Clopoat CLOPOAT ACNE-CLEARING SPOTCOLLOIDAL SULFURGuangzhou Meixi Biotechnology Co., Ltd.53cd1d6b-d44c-2508-e063-6294a90a96c62026-06-09WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDTwincraft Inc.4911ef14-b465-3398-e063-6394a90a9c9a2026-06-09WarningsExact identifier
application number: M006
PanOxyl Pore Refining Acne MaskSULFURCrown Laboratories, Inc.5373574c-95be-dd88-e063-6394a90ae5192026-06-05WarningsExact identifier
application number: M006
Acne Control SerumBENZOYL PEROXIDEPrivate Label Skin Cared4a4b89f-c9cf-4188-9c61-e8ef22b7638c2026-06-03WarningsExact identifier
application number: M006
BellamiLuxx Body acne cleanserBENZOYL PEROXIDE 4%BellamiLuxx LLC532baae0-7e6f-1764-e063-6394a90a11ce2026-06-01WarningsExact identifier
application number: M006
Clean and Clear Acne Spot TreatmentSALICYLIC ACIDKenvue Brands LLC532c48d7-6d7b-ba96-e063-6394a90a9c302026-06-01WarningsExact identifier
application number: M006
SkinCeuticals Blemish Plus Age Defense Acne TreatmentSALICYLIC ACIDLOreal USA Products Inc727fa830-1f71-40ae-8153-7a29dbcb5e292026-06-01WarningsExact identifier
application number: M006
Hero Pore Release Blackhead ClearingSALICYLIC ACIDChurch & Dwight Co., Inc.436cf03c-3f74-4a02-bb0a-1d24f5c4fc292026-06-01WarningsExact identifier
application number: M006
Principal Secret Blemish Buster ClearSALICYLIC ACIDGuthy-Renker LLC75387738-eca2-4184-833b-95005eb276662026-05-29WarningsExact identifier
application number: M006
KUGIG ACNE TREATMENT SPRAYERSALICYLIC ACIDGuangdong Jiaoyu Biotechnology Co., Ltd.52b1e9cb-c083-a6eb-e063-6294a90ab6d12026-05-26WarningsExact identifier
application number: M006
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPOBENZOYL PEROXIDELOreal USA Products Inc851882ac-56f4-4bf6-b942-6efea10eec3e2026-05-26WarningsExact identifier
application number: M006
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%MELON BIO-TECH (THAILAND) CO., LTD.201eeecd-e759-42b8-b5c2-b19465d983322026-05-25WarningsExact identifier
application number: M006
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%MELON BIO-TECH (THAILAND) CO., LTD.a5431ecd-0afc-4525-9157-ee05ff752df52026-05-25WarningsExact identifier
application number: M006
XEXLVOV MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVER LIQUIDShanghai Honghui Chuang Intelligent Technology Co., Ltd529bf32f-b40b-9602-e063-6294a90a1c2a2026-05-24WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSN20cb8584-8a31-40a8-8a47-d9fa8ec8abcf4
346298salicylic acid 0.02 MG/MG Topical GelSCD20cb8584-8a31-40a8-8a47-d9fa8ec8abcf4
346298salicylic acid 2 % Topical GelSY20cb8584-8a31-40a8-8a47-d9fa8ec8abcf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-035-0157337003501237 mg in 1 BOTTLE (57337-035-01) 237 mg2013-11-260000-00-00NoNoCurrent