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 59 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Baby Petroleum Jelly Skin Protectant Frag FreePETROLATUMMeijer Distribution0a0e6de8-b7c1-af7e-e063-6394a90a3ee22024-08-26WarningsExact identifier
application number: M016
Meijer Baby Petroleum Jelly Skin Protectant Fresh ScentPETROLATUMMeijer Distribution0a0e9b39-9ce1-e788-e063-6294a90abf0b2024-08-26WarningsExact identifier
application number: M016
Insect sting relief latex 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b9e2d4c-bc0c-6ed0-e063-6294a90a91032024-08-19WarningsExact identifier
application number: M016
DoveCARE AND PROTECT ANTIBACTERIAL HAND WASHConopco Inc. d/b/a/ Unileverb9f65122-4037-de0b-e053-2995a90ae5102024-08-16WarningsExact identifier
application number: M016
BioBarrier Repair Eye CreamALLANTOINBluemercury Inc.1ee70a3c-76cc-335f-e063-6294a90a4f492024-08-04WarningsExact identifier
application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHEDZINC OXIDEDabur India Ltd1e6143c1-cd08-c171-e063-6394a90a2cee2024-07-29WarningsExact identifier
application number: M016
HealthWise Petroleum JellyWHITE PETROLATUMVeridian Healthcare1e189d97-2677-e8d7-e063-6394a90ac3d62024-07-25WarningsExact identifier
application number: M016
Vitamin A and DVITAMIN A AND DMIDWOOD BRANDS, LLC1d0ebe9a-cbc5-1765-e063-6294a90aa4762024-07-18WarningsExact identifier
application number: M016
Kidgets Baby Petroleum JellyBABY PETROLEUM JELLYMIDWOOD BRANDS, LLC.1d0eb8be-13b7-c466-e063-6294a90a93b92024-07-11WarningsExact identifier
application number: M016
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
application number: M016
Best Choice Diaper RashZINC OXIDETrifecta Pharmaceuticals USA LLC1be37841-e0a8-a0de-e063-6294a90a9eb12024-06-27WarningsExact identifier
application number: M016
Gas Relief Ultra StrengthSIMETHICONEWalgreens00a9164a-1817-4130-9c7f-9f5833c9690f2024-06-26WarningsExact identifier
application number: M016
Astonea Skin ProtectantZINC OXIDEASTONEA LABS PRIVATE LIMITEDe3c7a515-3e77-da85-e053-2995a90a3ee12024-06-25WarningsExact identifier
application number: M016
Astonea Vitamin A and DWHITE PETROLATUMASTONEA LABS PRIVATE LIMITEDef7c357b-5ff6-b9d7-e053-2a95a90a1dcf2024-06-25WarningsExact identifier
application number: M016
ZOEY NATURALS DIAPER CreamZINC OXIDEAbsolutely Natural70fac4d6-8833-4799-b6b6-796f8f13f80e2024-06-25WarningsExact identifier
application number: M016
Medicated BodyMENTHOL AND ZINC OXIDEUniversal Distribution Center LLC2a59a847-cc7a-42cf-b49a-92e7254c16292024-06-19WarningsExact identifier
application number: M016
THERA Moisturizing Body ShieldDIMETHICONEMcKesson Medical-Surgical Inc.56869b64-11ee-4df6-8102-ce5818e0116e2024-06-18WarningsExact identifier
application number: M016
DimethiconeSKIN PROTECTANTMcKesson96886b33-44d4-5a2a-e053-2a95a90a505e2024-06-18WarningsExact identifier
application number: M016
Derma E Eczema ReliefOATMEALderma e767c4a76-8ccb-4530-9b4b-a7ea1a596c7f2024-06-18WarningsExact identifier
application number: M016
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact 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