Royal Antibacterial Passion Plum Hand Cleanse

Product NDC
50438-107
11-digit product format
504380107
Labeler code
50438
Product ID
50438-107_5ca9d71b-5e14-4d97-a492-a1d1e8ca1cf0
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
50438-107-012020-01-31C16284748780-19d75b9d0-db6a-f424-e053-dadaa90a57cec6ead0de-8f66-498b-84aa-660af772707f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50438-107-01Royal Antibacterial Passion Plum Hand Cleanse500 mL in 1 BOTTLEGEL5001

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50438-107ROYAL ANTIBACTERIAL PASSION PLUM HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1Legacy NDC, 1 package rows20130917_c6ead0de-8f66-498b-84aa-660af772707f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020118triclosan 0.15 % Medicated Liquid SoapPSNc6ead0de-8f66-498b-84aa-660af772707f1
1020118triclosan 1.5 MG/ML Medicated Liquid SoapSCDc6ead0de-8f66-498b-84aa-660af772707f1
1020118triclosan 0.15 % Medicated Liquid SoapSYc6ead0de-8f66-498b-84aa-660af772707f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50438-107-0150438010701500 mL in 1 BOTTLE500 mlHistorical