Royal Antibacterial (coconut and lime)

Product NDC
50438-600
11-digit product format
504380600
Labeler code
50438
Product ID
50438-600_28e530b4-133e-43fe-b17f-43302454eddb
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
2015-06-04
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
50438-600-012020-01-31C16284748780-19d75b9d0-7114-f424-e053-dadaa90a57ce616e8d16-933b-4350-b9c8-f6c908668dfa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50438-600-01Royal Antibacterial (coconut and lime)221 mL in 1 BOTTLEGEL2211

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50438-600ROYAL ANTIBACTERIAL (COCONUT AND LIME) (TRICLOSAN) GEL [FILO AMERICA]1Legacy NDC, 1 package rows20150604_616e8d16-933b-4350-b9c8-f6c908668dfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020118triclosan 0.15 % Medicated Liquid SoapPSN616e8d16-933b-4350-b9c8-f6c908668dfa1
1020118triclosan 1.5 MG/ML Medicated Liquid SoapSCD616e8d16-933b-4350-b9c8-f6c908668dfa1
1020118triclosan 0.15 % Medicated Liquid SoapSY616e8d16-933b-4350-b9c8-f6c908668dfa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50438-600-0150438060001221 mL in 1 BOTTLE221 mlHistorical