NDC 53567-0101

SuperSmile Professional Whitening

Fluoride

SuperSmile Professional Whitening is a Dental Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Robell Research, Inc.. The primary component is Sodium Monofluorophosphate.

Product ID53567-0101_e123425c-cbac-47c2-b511-b07c4b14dee5
NDC53567-0101
Product TypeHuman Otc Drug
Proprietary NameSuperSmile Professional Whitening
Generic NameFluoride
Dosage FormPaste, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2011-06-28
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameROBELL RESEARCH, INC.
Substance NameSODIUM MONOFLUOROPHOSPHATE
Active Ingredient Strength1 g/100g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53567-0101-6

227 g in 1 TUBE (53567-0101-6)
Marketing Start Date2011-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53567-0101-6 [53567010106]

SuperSmile Professional Whitening PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-06-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.76 g/100g

OpenFDA Data

SPL SET ID:43e5e8f9-1bb1-4154-b6a3-36af8c870c4d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 545626

    • NDC Crossover Matching brand name "SuperSmile Professional Whitening" or generic name "Fluoride"

    NDCBrand NameGeneric Name
    53567-0101SuperSmile Professional WhiteningSuperSmile Professional Whitening
    53567-6044SuperSmile Professional WhiteningSuperSmile Professional Whitening
    0404-3339AccleanFluoride
    0404-3963AccleanFluoride
    0404-4447AccleanFluoride
    0404-4448AccleanFluoride
    0404-5676AccleanFluoride
    0404-9034AccleanFluoride
    0404-9035AccleanFluoride
    0404-9405AccleanFluoride
    37808-167HEBFluoride
    30142-148KrogerFluoride
    30142-149KrogerFluoride
    30142-621Kroger CompanyFluoride
    36800-185Live BetterFluoride
    34362-0237Peppermint TwistFluoride
    11822-5020Rite AidFluoride
    11822-6020Rite AidFluoride
    34362-0232The Natural DentistFluoride
    34362-0233The Natural DentistFluoride
    34362-0270The Natural DentistFluoride
    36800-186Top CareFluoride
    36800-681Top CareFluoride
    36800-481Topco Associates LLCFluoride
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