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
2027-12-31

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 54 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artistry Studio Done With Zit Acne Treatment Clearing GelSALICYLIC ACIDAccess Business Group LLC7a9bb4a0-c463-44e8-90a3-12bd58829f9d2023-10-21WarningsExact identifier
application number: M006
PERSISTENT BODY ACNE WASH 8.5OZSALICYLIC ACIDChina Ningbo Shangge Cosmetics Technology Corp.074079cd-866d-0af0-e063-6394a90a72142023-10-09WarningsExact identifier
application number: M006
Skin Laundry. Clean Slate Exfoliating 2 Salicylic Acid Treatment Gel Cleanser Cleanse ExfoliateSALICYLIC ACIDSkin Laundry Holdings, Inc.07100fe5-3884-0948-e063-6294a90a6ec72023-10-06WarningsExact identifier
application number: M006
NAS PORE REFINING SCRUBSALICYLIC ACIDBURT'S BEES, INC.bc2c6b1e-999c-91a7-e053-2a95a90a9d1a2023-10-05WarningsExact identifier
application number: M006
NAS Targeted Spot TreatmentSALICYLIC ACIDBurt's Beesbc193e1f-c2bd-6415-e053-2995a90ae6eb2023-10-05WarningsExact identifier
application number: M006
ACNE AND LINE CORRECTING SERUMSALICYLIC ACIDCLINIQUE LABORATORIES LLCb03bdef4-a099-4543-8673-85466bd649612023-10-05WarningsExact identifier
application number: M006
SPOT ACNE TREATMENT 0.75OZBENZOYL PEROXIDERejoice International Corp.06de40a2-45bf-bf4b-e063-6294a90a586c2023-10-04WarningsExact identifier
application number: M006
PERSISTENT BODY ACNE WASH 8.5OZSALICYLIC ACIDRejoice International Corp.06df07f7-e4c5-ccef-e063-6394a90a9f3c2023-10-04WarningsExact identifier
application number: M006
SPOT ACNE TREATMENT 0.75OZBENZOYL PEROXIDEChina Ningbo Shangge Cosmetics Technology Corp.06e07266-6483-e7ef-e063-6294a90a93952023-10-04WarningsExact identifier
application number: M006
Acne ControlCREAMWalgreenfc60cccb-405b-e49e-e053-6394a90a5a122023-09-11WarningsExact identifier
application number: M006
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
application number: M006
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
application number: M006
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
application number: M006
ACNE CLEANSINGSALICYLIC ACIDCLINIQUE LABORATORIES LLC7bae5802-cf51-4b41-9d7c-d72f1eb4c4af2023-08-30WarningsExact identifier
application number: M006
Gly-Sal 2-2 PadsSALICYLIC ACIDTopiderm, Inc.a92a9ffb-5c5b-43a4-b669-04667324920b2023-02-16WarningsExact identifier
application number: M006
Derma E Acne Clarifying MaskSULFURderma e55df8fb4-abc3-43fe-b89b-6e7d638b27a62023-02-14WarningsExact 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