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
2026-12-31
Current FDA listing
Yes

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 1 of 56 · 1,105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defense Acne Care 2% Salicylic AcidSALICYLIC ACID 2%Defense Soap LLC98fcc243-d789-181d-e053-2995a90a9b5d2026-09-09WarningsExact identifier
application number: M006
Jack Black Bump FixSALICYLIC ACIDJack Black, L.L.C.e8f51678-2675-405c-8462-351ec260051a2026-09-08WarningsExact identifier
application number: M006
Abib Acne foam cleanser Heartleaf foamSALICYLIC ACIDFourcompany Co., Ltd.5aa353ad-0ca5-77c1-e063-6394a90a62542026-09-04WarningsExact identifier
application number: M006
Dr.Leo Acne Buster Salicylic Acid DryingSALICYLIC ACIDDoctor Leo USA Inc5792fa71-eb6b-3c70-e063-6394a90abde82026-09-03WarningsExact identifier
application number: M006
Blackhead Clearing ScrugSALICYLIC ACIDWalmart Inc.6989591a-a78b-4971-baf2-51ebfaf9c7e72026-09-02Warnings, Adverse reactionsExact identifier
application number: M006
Beisitian FACIAL BUMP REFINING ESSENCESALICYLIC ACID 2% FACIAL BUMP REFINING ESSENCEWenzhou Yuyuan Pharmaceutical Co., Ltd.5a6784cd-93d3-aecc-e063-6294a90af0212026-09-01WarningsExact identifier
application number: M006
Folliculitis Treatment CreamBENZOYL PEROXIDEGuangzhou Hechuang Commercial Service Co.,Ltd.5a93f753-eb7d-ad11-e063-6294a90a67782026-09-01WarningsExact identifier
application number: M006
INVISIBLE ACNE PATCHESSALICYLIC ACID 0.5%Global America Group LLC1527e15f-472f-4e05-adb6-c2e561f503cf2026-08-31WarningsExact identifier
application number: M006
The Acne Spot TreatmentSALICYLIC ACID SPOTSpotless, Inc.4a1a3716-9eaf-6be4-e063-6294a90a31c32026-08-30WarningsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Your Military Exchanges57f06989-3ffa-4cd3-bde5-9d3cc639ac4d2026-08-28Warnings, Adverse reactionsExact identifier
application number: M006
Proactivplus Pore Clearing TreatmentSALICYLIC ACIDAlchemee, LLC334efe89-3775-5ddb-e063-6294a90ae3a82026-08-27WarningsExact identifier
application number: M006
GENTLE ACNE CLEANSERSALICYLIC ACIDDrmtlgy, LLC2abed972-3fae-4ef0-abb6-1883457e98be2026-08-26WarningsExact identifier
application number: M006
RAVN Mens Back AcneSALICYLIC ACIDNorth Forge Brands LLC4a512df2-4ad7-495c-868a-1f4d0a8863912026-08-26WarningsExact identifier
application number: M006
Salicylic Acid Body WashSALICYLIC ACIDGuangdong Danlan International Biotechnology Co., Ltd59d671e7-7bbc-a963-e063-6394a90a776f2026-08-24WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDWalmart Inc.5a76498e-a6f6-4e04-a2c7-245be947b0062026-08-21Warnings, Adverse reactionsExact identifier
application number: M006
Acne Treatment CreamBENZOYL PEROXIDECVS Healthaef82711-e3c3-439d-adda-542933ff44202026-08-19WarningsExact identifier
application number: M006
Tula Skincare Acne Heroes Acne Clearing KitSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5967255f-b511-9c7f-e063-6294a90a3e632026-08-19WarningsExact identifier
application number: M006
BYT BANGYTONG MILIA REMOVERSALICYLIC ACID 2% MILIA REMOVERShenzhen Jindali Technology Co., Ltd596a2471-d07c-14a5-e063-6394a90a4fcc2026-08-19WarningsExact identifier
application number: M006
RFA Clear and Calm Balancing SerumSALICYLIC ACIDTopiderm, Inc.f63f2c89-3567-4b08-be51-3fdfc5e0b1ba2026-08-14WarningsExact identifier
application number: M006
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58e901b8-66e0-d2d6-e063-6394a90ae6012026-08-13WarningsExact 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