Royal Antibacterial (apple and pear) moisturizing hand cleanse

Product NDC
50438-602
11-digit product format
504380602
Labeler code
50438
Product ID
50438-602_2b8999bb-77b9-4ceb-89c0-08a52400a867
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
50438-602-012020-01-31C16284748780-19d75b9d0-9e2f-f424-e053-dadaa90a57ceb6373be0-f3aa-4306-8b6b-5e076cc72376

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50438-602-01Royal Antibacterial (apple and pear) moisturizing hand cleanse444 mL in 1 BOTTLEGEL4441

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50438-602ROYAL ANTIBACTERIAL (APPLE AND PEAR) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]1Legacy NDC, 1 package rows20150605_b6373be0-f3aa-4306-8b6b-5e076cc72376.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020118triclosan 0.15 % Medicated Liquid SoapPSNb6373be0-f3aa-4306-8b6b-5e076cc723761
1020118triclosan 1.5 MG/ML Medicated Liquid SoapSCDb6373be0-f3aa-4306-8b6b-5e076cc723761
1020118triclosan 0.15 % Medicated Liquid SoapSYb6373be0-f3aa-4306-8b6b-5e076cc723761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50438-602-0150438060201444 mL in 1 BOTTLE444 mlHistorical