Royal Antibacterial Tropical Fruit Hand Cleanse

Product NDC
50438-108
11-digit product format
504380108
Labeler code
50438
Product ID
50438-108_701409ce-fddc-4257-baeb-e18939be1d55
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
2013-09-17
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
50438-108-012020-01-31C16284748780-19d75b9d0-db73-f424-e053-dadaa90a57cef3399ba7-231a-4c74-be4a-9890d4001666

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50438-108-01Royal Antibacterial Tropical Fruit Hand Cleanse500 mL in 1 BOTTLEGEL5001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
TRICLOSANACTIVE MOIETY4NM5039Y5XROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0ROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1
WATERINACTIVE INGREDIENT059QF0KO0RROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50438-108ROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1Legacy NDC, 1 package rows20130917_f3399ba7-231a-4c74-be4a-9890d4001666.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020118triclosan 0.15 % Medicated Liquid SoapPSNf3399ba7-231a-4c74-be4a-9890d40016661
1020118triclosan 1.5 MG/ML Medicated Liquid SoapSCDf3399ba7-231a-4c74-be4a-9890d40016661
1020118triclosan 0.15 % Medicated Liquid SoapSYf3399ba7-231a-4c74-be4a-9890d40016661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50438-108-0150438010801500 mL in 1 BOTTLE500 mlHistorical