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#

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 35 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Breakout Clearing Foaming WashSALICYLIC ACIDDermalogicae55d212b-7687-47fd-86ec-f8709804dd042024-12-24WarningsExact identifier
application number: M006
BREAKOUT CLEARING BOOSTERSALICYLIC ACIDDermalogica, Inc.6a3bb679-8a03-4f0a-950e-5a40f2b5b70e2024-12-24WarningsExact identifier
application number: M006
AGE Bright Clearing SerumSALICYLIC ACIDDermalogica, Incd5291f67-3329-42c7-b9c2-9bae797ecb5b2024-12-24WarningsExact identifier
application number: M006
Maybelline Dream Pure BB Beauty BalmSALICYLIC ACIDL'Oreal USA Products Inc553bea8f-92cd-416c-8bc1-39e4ec9cfcb42024-12-23WarningsExact identifier
application number: M006
Thayers Natural Remedies Since 1847 Blemish Clearing CleanserSALICYLIC ACIDLOreal USA Products Inc4e03b29c-6d1c-473c-91b9-291a0cb523fb2024-12-23WarningsExact identifier
application number: M006
Dr Throwers Oily Skin Facial AstringentSALICYLIC ACID 2%Derma Care Research Labs, LLCd692e7e2-11c7-7b4a-e053-2a95a90ae17b2024-12-20WarningsExact identifier
application number: M006
Dr Throwers Oily Skin Facial CleanserSALICYLIC ACID 2%Derma Care Research Labs, LLCd6e59f75-cd3d-3fc4-e053-2a95a90abf4c2024-12-20WarningsExact identifier
application number: M006
Monat Acne TreatmentBENZOYL PEROXIDEMonat Global Corpf76eb53e-643d-52cf-e053-6394a90a6e8f2024-12-20WarningsExact identifier
application number: M006
Dermaharmony 10% Benzoyl Peroxide Cleansing BarBENZOYL PEROXIDED3 Development, Inc.c7083b69-fed4-d497-e053-2a95a90a1a8c2024-12-20WarningsExact identifier
application number: M006
Dermaharmony 5% Benzoyl Peroxide Cleansing BarBENZOYL PEROXIDED3 Development, Inc.c7ceae0d-3215-1f83-e053-2995a90a60bc2024-12-20WarningsExact identifier
application number: M006
Detox Drops 2% Salicylic Acid Acne TonerSALICYLIC ACIDCOSMAX USA, CORPORATION2999c85e-cb4b-719e-e063-6394a90a0f282024-12-19WarningsExact identifier
application number: M006
OXY 3 in 1 Acne PadsSALICYLIC ACIDThe Mentholatum Company5b1c8f11-3b5b-4c26-b4c1-0770d1dd823a2024-12-17WarningsExact identifier
application number: M006
Phisoderm Clear Confidence Spot TreatmentBENZOYL PEROXIDEThe Mentholatum Company2a51c80a-27e8-44d3-b06f-b2a9081c57962024-12-17WarningsExact identifier
application number: M006
Oxy 10 VanishingBENZOYL PEROXIDEThe Mentholatum Companyd499b69a-25aa-4e3d-a07e-a774bc0d65f12024-12-17WarningsExact identifier
application number: M006
OXY Volcanic Clay Acne WashSALICYLIC ACIDThe Mentholatum Companyeb2a0e0b-2ed5-4c14-8607-0b61ca48c4952024-12-17WarningsExact identifier
application number: M006
OXY Volcanic Ash Acne Face WashSALICYLIC ACIDThe Mentholatum Company6d768d3d-c1df-4a85-9c76-7f7a2ec90b2d2024-12-17WarningsExact identifier
application number: M006
Oxy 10 TintedBENZOYL PEROXIDEThe Mentholatum Company0ceee85d-dc8c-49b3-9b44-8fe60022c2432024-12-17WarningsExact identifier
application number: M006
Oxy 5 VanishingBENZOYL PEROXIDEThe Mentholatum Companyc4aa0fff-6e4a-47a8-9adc-ac2426f8292e2024-12-17WarningsExact identifier
application number: M006
Oxy 5 TintedBENZOYL PEROXIDEThe Mentholatum Company94c863f0-711a-4807-ba1f-a56c7e3f86702024-12-17WarningsExact identifier
application number: M006
Phisoderm Anti Blemish Body WashSALICYLIC ACIDThe Mentholatum Companybba14225-2970-4678-b5a1-78ed94c389d92024-12-17WarningsExact 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