NDC 71401-0007

2080 K Original

Sodium Fluoride

2080 K Original is a Dental Paste in the Human Otc Drug category. It is labeled and distributed by Ak America. The primary component is Sodium Fluoride.

Product ID71401-0007_1442bcf2-3fd6-4e8b-ad9e-4773449fca39
NDC71401-0007
Product TypeHuman Otc Drug
Proprietary Name2080 K Original
Generic NameSodium Fluoride
Dosage FormPaste
Route of AdministrationDENTAL
Marketing Start Date2017-01-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameAK AMERICA
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 g/120g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 71401-0007-1

1 TUBE in 1 PACKAGE (71401-0007-1) > 120 g in 1 TUBE
Marketing Start Date2017-01-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71401-0007-1 [71401000701]

2080 K Original PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-02
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.12 g/120g

OpenFDA Data

SPL SET ID:cbc91185-b8ee-4b6c-9b8d-d8f7ec30b9b5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245598
  • NDC Crossover Matching brand name "2080 K Original" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    71401-00072080 K Original2080 K Original
    67225-00072080 K Original2080 K Original
    0135-0234AQUAFRESHsodium fluoride
    0126-0021ColgateSODIUM FLUORIDE
    0126-0034Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape FluorideSODIUM FLUORIDE
    0126-0032Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint FluorideSODIUM FLUORIDE
    0041-1421Oral-BSodium Fluoride
    0126-0131Phos-FlurSodium Fluoride
    0126-0135Phos-Flur Ortho DefenseSODIUM FLUORIDE
    0126-0138Phos-Flur Ortho DefenseSODIUM FLUORIDE
    0126-0139Phos-Flur Ortho DefenseSODIUM FLUORIDE
    0126-0074PrevidDent 5000 Booster Plus SpearmintSodium Fluoride
    0126-0016PreviDentSodium fluoride
    0126-0075PreviDentSodium fluoride
    0126-0076PreviDentSodium fluoride
    0126-0179PreviDentSodium Fluoride
    0126-0286PreviDentSodium Fluoride
    0126-0287PreviDentSodium Fluoride
    0126-0072PreviDent 5000 Booster Plus FruitasticSodium Fluoride
    0126-0033PreviDent Alcohol FreeSodium Fluoride
    0126-0088PreviDent Fresh MintSodium Fluoride
    0126-0289PreviDent OrthoDefenseSODIUM FLUORIDE
    0126-0288PreviDent Very BerrySodium Fluoride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.