XtraCare Antibacterial Hand Cleanse

Product NDC
57337-069
11-digit product format
573370069
Labeler code
57337
Product ID
57337-069_2decfde9-cfb3-3dbb-e063-6294a90aac46
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
2013-09-03
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
Fresh Citrus
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
57337-069-012025-02-12C16284748780-12cef2736-a759-d83d-e063-dadaa90ab31fXtraCare Antibacterial Hand Cleanse
57337-069-012025-01-30C16284748780-12cef2736-a759-d83d-e063-dadaa90ab31fXtraCare Antibacterial Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-069-01XtraCare Antibacterial Hand CleanseFresh Citrus221 mL in 1 BOTTLESOAP2213

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
TRICLOSANACTIVE MOIETY4NM5039Y5XXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-069XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20250214_e87ef6e6-ef41-43c4-bfdf-b7e3446436b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020118triclosan 0.15 % Medicated Liquid SoapPSNe87ef6e6-ef41-43c4-bfdf-b7e3446436b73
1020118triclosan 1.5 MG/ML Medicated Liquid SoapSCDe87ef6e6-ef41-43c4-bfdf-b7e3446436b73
1020118triclosan 0.15 % Medicated Liquid SoapSYe87ef6e6-ef41-43c4-bfdf-b7e3446436b73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-069-0157337006901221 mL in 1 BOTTLE (57337-069-01) 221 ml2013-09-030000-00-00NoNoCurrent