NDC 57511-0101

FluoriMax 5000

1.1% Sodium Fluoride Toothpaste

FluoriMax 5000 is a Topical Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Elevate Oral Care. The primary component is Sodium Fluoride.

Product ID57511-0101_728ce5e0-c624-1364-e053-2a91aa0a3e2d
NDC57511-0101
Product TypeHuman Otc Drug
Proprietary NameFluoriMax 5000
Generic Name1.1% Sodium Fluoride Toothpaste
Dosage FormPaste, Dentifrice
Route of AdministrationTOPICAL
Marketing Start Date2015-02-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameElevate Oral Care
Substance NameSODIUM FLUORIDE
Active Ingredient Strength1 g/100g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 57511-0101-3

96 g in 1 TUBE (57511-0101-3)
Marketing Start Date2015-02-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57511-0101-3 [57511010103]

FluoriMax 5000 PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-02-02
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE1.1 g/100g

OpenFDA Data

SPL SET ID:81c2c9f2-1a2e-474e-b150-4e336f213699
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 392038
  • NDC Crossover Matching brand name "FluoriMax 5000" or generic name "1.1% Sodium Fluoride Toothpaste"

    NDCBrand NameGeneric Name
    57511-0101FluoriMax 50001.1% Sodium Fluoride Toothpaste
    57511-0504FluoriMax 50001.1% Sodium Fluoride Toothpaste
    57511-0005Allday 50001.1% Sodium Fluoride Toothpaste
    57511-0001Just Right 50001.1% Sodium Fluoride Toothpaste
    57511-0002Just Right 50001.1% Sodium Fluoride Toothpaste
    57511-0003Just Right 50001.1% Sodium Fluoride Toothpaste
    57511-0108Just Right 50001.1% Sodium Fluoride Toothpaste
    57511-0119Just Right 50001.1% Sodium Fluoride Toothpaste
    57511-0120Just Right 50001.1% Sodium Fluoride Toothpaste
    57511-0122Just Right 50001.1% Sodium Fluoride Toothpaste

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