Royal Antibacterial (coconut and lime) moisturizing hand cleanse

Product NDC
50438-603
11-digit product format
504380603
Labeler code
50438
Product ID
50438-603_1eedb0ce-d81a-4ace-879b-a4e483e4556d
Type
HUMAN OTC DRUG
Nonproprietary name
Triclosan
Dosage form
GEL
Route
TOPICAL
Labeler
Filo America
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-06-05
Marketing end
0000-00-00
Substance
TRICLOSAN
Active strength
2 mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50438-603-012020-01-31C16284748780-19d75b9d0-451c-f424-e053-dadaa90a57cec249907e-f5b0-46c0-bc6a-d1000d84c1d7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50438-603-01Royal Antibacterial (coconut and lime) moisturizing hand cleanse444 mL in 1 BOTTLEGEL4441

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
TRICLOSANACTIVE MOIETY4NM5039Y5XROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0ROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
WATERINACTIVE INGREDIENT059QF0KO0RROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50438-603ROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1Legacy NDC, 1 package rows20150605_c249907e-f5b0-46c0-bc6a-d1000d84c1d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020118triclosan 0.15 % Medicated Liquid SoapPSNc249907e-f5b0-46c0-bc6a-d1000d84c1d71
1020118triclosan 1.5 MG/ML Medicated Liquid SoapSCDc249907e-f5b0-46c0-bc6a-d1000d84c1d71
1020118triclosan 0.15 % Medicated Liquid SoapSYc249907e-f5b0-46c0-bc6a-d1000d84c1d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50438-603-0150438060301444 mL in 1 BOTTLE444 mlHistorical