XtraCare Antibacterial Hand Cleanse

Product NDC
58503-021
11-digit product format
585030021
Labeler code
58503
Product ID
58503-021_edb1ab1c-10a3-2141-e053-2a95a90aad49
Type
HUMAN OTC DRUG
Nonproprietary name
Triclosan
Dosage form
SOAP
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetic Technology Corp.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-09-03
Marketing end
0000-00-00
Substance
TRICLOSAN
Active strength
3 mg/221mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-021-012025-01-30C16284748780-12cef2736-af29-d83d-e063-dadaa90ab31fXtraCare Antibacterial Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-021-01XtraCare Antibacterial Hand CleanseOriginal221 mL in 1 BOTTLESOAP2214

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
TRICLOSANACTIVE MOIETY4NM5039Y5XXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-021XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]4Legacy NDC, 1 package rows20221118_95826994-26dd-4635-95b8-e13988f7663d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020118triclosan 0.15 % Medicated Liquid SoapPSN95826994-26dd-4635-95b8-e13988f7663d4
1020118triclosan 1.5 MG/ML Medicated Liquid SoapSCD95826994-26dd-4635-95b8-e13988f7663d4
1020118triclosan 0.15 % Medicated Liquid SoapSY95826994-26dd-4635-95b8-e13988f7663d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-021-0158503002101221 mL in 1 BOTTLE (58503-021-01) 221 ml2013-09-030000-00-00NoNoCurrent