XtraCare Foaming Facial Cleanser

Product NDC
57337-036
11-digit product format
573370036
Labeler code
57337
Product ID
57337-036_126d79f0-68eb-8a53-e063-6294a90a6fe1
Type
HUMAN OTC DRUG
Nonproprietary name
Triclosan
Dosage form
GEL
Route
TOPICAL
Labeler
Rejoice International
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-26
Substance
TRICLOSAN
Active strength
1 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 Foaming Facial Cleanser
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRICLOSAN1 mg/237mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NM5039Y5XInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
313fcd4a-8641-417e-bf0b-02359ad815feAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-036-012024-02-28C16284748780-11030e365-0263-111a-e063-dadaa90a10e2XtraCare Foaming Facial Cleanser
57337-036-012024-01-30C16284748780-11030e365-0263-111a-e063-dadaa90a10e2XtraCare Foaming Facial Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-036-01XtraCare Foaming Facial Cleanser237 mg in 1 BOTTLEGEL2373

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1
TRICLOSANACTIVE MOIETY4NM5039Y5XXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1
POLYOXYL 40 CASTOR OILINACTIVE INGREDIENT4ERD2076EFXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-036XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_313fcd4a-8641-417e-bf0b-02359ad815fe.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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERA Calazinc Body ShieldZINC OXIDEMcKesson Medical-Surgical Inc.974b1046-83ee-4207-91d3-40982beb9c632024-06-17WarningsExact identifier
application number: M016
DimethiconeBODY CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
application number: M016
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
application number: M016
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
application number: M016
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.186a9642-cd73-adfb-e063-6394a90a75c72024-05-14WarningsExact identifier
application number: M016
Honest Eczema BalmCOLLOIDAL OATMEALThe Honest Company, Inc.35b8bc5c-420e-4d31-9659-f36cabbd897a2024-05-14WarningsExact identifier
application number: M016
Extra Strength Itch StoppingITCH STOPPING CREAMUniversal Distribution Centre LLCb9a42aa3-1903-76f0-e053-2a95a90a51d12024-05-13WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONCardinal Health, 110 dba Leader7f733c0a-82b2-d3b0-e053-2991aa0a6b0f2024-05-13WarningsExact identifier
application number: M016
Walgreens Maximum Diaper RashZINC OXIDEWalgreens Company5eb2152f-6fa2-4191-878a-207416e698182024-05-07WarningsExact identifier
application number: M016
Cetaphil Eczema Rapid Relief CreamCOLLOIDAL OATMEALGalderma Laboratories, L.P.02a405fa-8ae9-41e9-b86f-ef5fb6e3844a2024-05-02WarningsExact identifier
application number: M016
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
application number: M016
Diaper Rash Cream 40% ZINCZINC OXIDEASTONEA LABS PRIVATE LIMITED16da985a-6210-ec82-e063-6294a90a132d2024-04-24WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
application number: M016
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
application number: M016
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
application number: M016
ARC Skin ProtectantALLANTOINAnjon Biologics, Incf4ff79dd-cb38-4cca-9631-a2758a1718732024-04-18WarningsExact identifier
application number: M016
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
application number: M016
Chapstick Moisturizer Variety PackAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCbfb9a2d5-1ad2-45b8-a215-9d1370af53372024-04-12WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-036-0157337003601237 mg in 1 BOTTLE (57337-036-01) 237 mg2013-11-260000-00-00NoNoCurrent