FDA.reportPublic FDA data

SuperSmile Professional

Product NDC
53567-6044
11-digit product format
535676044
Labeler code
53567
Product ID
53567-6044_1d9c0c38-cbc7-4aef-b188-ecc3898bb42d
Type
HUMAN OTC DRUG
Nonproprietary name
Toothpaste
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Robell Research, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-06-28
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53567-6044-22020-01-31C16284748780-19d75b9d0-5b72-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53567-6044-2SuperSmile ProfessionalWhitening227 g in 1 TUBEPASTE, DENTIFRICE2274

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QSUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
MONOFLUOROPHOSPHATE IONACTIVE MOIETY4964UZ79MISUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKSUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
CALCIUM PEROXIDEINACTIVE INGREDIENT7FRO2ENO91SUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NASUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
SACCHARININACTIVE INGREDIENTFST467XS7DSUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
SODIUM LAURYL SULFOACETATEINACTIVE INGREDIENTD0Y70F2B9JSUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
SODIUM PERBORATEINACTIVE INGREDIENTY52BK1W96CSUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RSUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53567-6044SUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]4Legacy NDC, 1 package rows20121010_6313d26c-aa25-45c8-845a-a560bccc57c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1247591sodium monofluorophosphate 0.83 % (fluoride 0.11 % ) ToothpastePSN6313d26c-aa25-45c8-845a-a560bccc57c54
1247591sodium monofluorophosphate 0.0083 MG/MG ToothpasteSCD6313d26c-aa25-45c8-845a-a560bccc57c54
1247591sodium monofluorophosphate 0.83 % ToothpasteSY6313d26c-aa25-45c8-845a-a560bccc57c54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53567-6044-253567604402227 g in 1 TUBE227 gHistorical