NDC 57511-0119

Just Right 5000

1.1% Sodium Fluoride Toothpaste

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

Product ID57511-0119_728ce5e0-c60e-1364-e053-2a91aa0a3e2d
NDC57511-0119
Product TypeHuman Otc Drug
Proprietary NameJust Right 5000
Generic Name1.1% Sodium Fluoride Toothpaste
Dosage FormGel, Dentifrice
Route of AdministrationTOPICAL
Marketing Start Date2018-01-01
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 57511-0119-8

91 g in 1 TUBE (57511-0119-8)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57511-0119-8 [57511011908]

Just Right 5000 GEL, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE1.11 g/100g

OpenFDA Data

SPL SET ID:5aa80253-a729-26fc-e053-2a91aa0adc23
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 392038
  • NDC Crossover Matching brand name "Just Right 5000" or generic name "1.1% Sodium Fluoride Toothpaste"

    NDCBrand NameGeneric Name
    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
    57511-0005Allday 50001.1% Sodium Fluoride Toothpaste
    57511-0101FluoriMax 50001.1% Sodium Fluoride Toothpaste
    57511-0504FluoriMax 50001.1% Sodium Fluoride Toothpaste

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