NDC 52644-003

Oral Defense

Sodium Fluoride

Oral Defense is a Dental Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Oral Defense. The primary component is Sodium Fluoride.

Product ID52644-003_d9a9c8ea-b2da-4f23-ad65-23b174df6f9d
NDC52644-003
Product TypeHuman Otc Drug
Proprietary NameOral Defense
Generic NameSodium Fluoride
Dosage FormPaste, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2011-07-12
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameOral Defense
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 g/118g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52644-003-01

1 TUBE in 1 BOX (52644-003-01) > 118 g in 1 TUBE (52644-003-00)
Marketing Start Date2011-07-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52644-003-00 [52644000300]

Oral Defense PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-07-12

NDC 52644-003-01 [52644000301]

Oral Defense PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-01-28
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.14 g/118g

OpenFDA Data

SPL SET ID:4cf196f6-a726-4879-a4d8-7e0c08c0a7a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1044547
    • UPC Code
  • 0093743538701

    • NDC Crossover Matching brand name "Oral Defense" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    52644-001Oral DefenseOral Defense
    52644-003Oral DefenseOral Defense
    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

    Trademark Results [Oral Defense]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ORAL DEFENSE
    ORAL DEFENSE
    78870773 3394932 Live/Registered
    Oral Defense LLC
    2006-04-27
    ORAL DEFENSE
    ORAL DEFENSE
    75885140 not registered Dead/Abandoned
    BioGlobe Technologies, Inc.
    2000-01-06
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