NDC 63956-004

Emmi-dent Fresh

Sodium Fluoride

Emmi-dent Fresh is a Dental Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Emag Ag. The primary component is Sodium Fluoride.

Product ID63956-004_44d1ed60-1de5-49e0-bfe4-45208180a4e9
NDC63956-004
Product TypeHuman Otc Drug
Proprietary NameEmmi-dent Fresh
Generic NameSodium Fluoride
Dosage FormPaste, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2019-07-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameEMAG AG
Substance NameSODIUM FLUORIDE
Active Ingredient Strength199 mg/75mL
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 63956-004-01

1 TUBE in 1 CARTON (63956-004-01) > 75 mL in 1 TUBE
Marketing Start Date2019-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63956-004-01 [63956000401]

Emmi-dent Fresh PASTE, DENTIFRICE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-15

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE199 mg/75mL

OpenFDA Data

SPL SET ID:1986a759-7dec-4287-884b-556cf314679e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1235783

    • NDC Crossover Matching brand name "Emmi-dent Fresh" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    63956-004Emmi-dent FreshEmmi-dent Fresh
    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
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