NDC 36800-481

Topco Associates LLC Maximum Strength

Fluoride

Topco Associates LLC Maximum Strength is a Dental Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Sodium Fluoride; Potassium Nitrate.

Product ID36800-481_8878c78d-128e-429b-868d-4364f9fcb364
NDC36800-481
Product TypeHuman Otc Drug
Proprietary NameTopco Associates LLC Maximum Strength
Generic NameFluoride
Dosage FormPaste, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2011-01-20
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameTopco Associates LLC
Substance NameSODIUM FLUORIDE; POTASSIUM NITRATE
Active Ingredient Strength0 g/100g; g/100g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 36800-481-49

1 TUBE in 1 CARTON (36800-481-49) > 113 g in 1 TUBE (36800-481-42)
Marketing Start Date2012-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-481-42 [36800048142]

Topco Associates LLC Maximum Strength PASTE, DENTIFRICE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-01-20

NDC 36800-481-49 [36800048149]

Topco Associates LLC Maximum Strength PASTE, DENTIFRICE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-11-15

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.24 g/100g

OpenFDA Data

SPL SET ID:ac398ff0-0010-4e13-8b89-dc986fd7f974
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1038929
  • NDC Crossover Matching brand name "Topco Associates LLC Maximum Strength" or generic name "Fluoride"

    NDCBrand NameGeneric Name
    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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