NDC 52644-002

Oral Defense Fluoride Rinse

Sodium Fluoride

Oral Defense Fluoride Rinse is a Oral Mouthwash in the Human Otc Drug category. It is labeled and distributed by Oral Defense, Llc. The primary component is Sodium Fluoride.

Product ID52644-002_bc01abf8-ac41-40c1-a4ab-1d4ba7c64a42
NDC52644-002
Product TypeHuman Otc Drug
Proprietary NameOral Defense Fluoride Rinse
Generic NameSodium Fluoride
Dosage FormMouthwash
Route of AdministrationORAL
Marketing Start Date2010-08-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameOral Defense, LLC
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 g/474mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52644-002-00

474 mL in 1 BOTTLE, PLASTIC (52644-002-00)
Marketing Start Date2010-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52644-002-02 [52644000202]

Oral Defense Fluoride Rinse MOUTHWASH
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-08-31
Inactivation Date2019-11-27

NDC 52644-002-00 [52644000200]

Oral Defense Fluoride Rinse MOUTHWASH
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-08-31
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.2418 g/474mL

OpenFDA Data

SPL SET ID:59a1f399-3609-4eef-b635-1f526cd75819
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 240698

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

    NDCBrand NameGeneric Name
    52644-002Oral Defense Fluoride RinseOral Defense Fluoride Rinse
    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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