FDA.reportPublic FDA data

XtraCare Antibacterial Hand Cleanse

Product NDC
57337-023
11-digit product format
573370023
Labeler code
57337
Product ID
57337-023_126c40d2-9d18-e72a-e063-6294a90ad790
Type
HUMAN OTC DRUG
Nonproprietary name
Triclosan
Dosage form
SOAP
Route
TOPICAL
Labeler
Rejoice International, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-30
Substance
TRICLOSAN
Active strength
3.3 mg/221mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XtraCare Antibacterial Hand Cleanse
Brand name suffix
Strawberry Pomegranate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRICLOSAN3.3 mg/221mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NM5039Y5X
Rxcui1020118

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-023-012024-02-28C16284748780-11030e365-0bcf-111a-e063-dadaa90a10e2XtraCare Antibacterial Hand Cleanse
57337-023-012024-01-30C16284748780-11030e365-0bcf-111a-e063-dadaa90a10e2XtraCare Antibacterial Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-023-01XtraCare Antibacterial Hand CleanseStrawberry Pomegranate221 mL in 1 BOTTLESOAP2216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
TRICLOSANACTIVE MOIETY4NM5039Y5XXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-023XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]6Current NDC, Legacy NDC, 1 package rows20240229_b68a7d64-2650-4fc6-a89e-05de9098a2a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020118triclosan 0.15 % Medicated Liquid SoapPSNb68a7d64-2650-4fc6-a89e-05de9098a2a36
1020118triclosan 1.5 MG/ML Medicated Liquid SoapSCDb68a7d64-2650-4fc6-a89e-05de9098a2a36
1020118triclosan 0.15 % Medicated Liquid SoapSYb68a7d64-2650-4fc6-a89e-05de9098a2a36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-023-0157337002301221 mL in 1 BOTTLE (57337-023-01) 221 ml2013-08-300000-00-00NoNoCurrent