NDC 0126-0135

Phos-Flur Ortho Defense

Sodium Fluoride

Phos-Flur Ortho Defense is a Dental Rinse in the Human Otc Drug category. It is labeled and distributed by Colgate Oral Pharmaceuticals, Inc.. The primary component is Sodium Fluoride.

Product ID0126-0135_3da7c2c8-f2d2-4605-b90d-9ba623d95048
NDC0126-0135
Product TypeHuman Otc Drug
Proprietary NamePhos-Flur Ortho Defense
Generic NameSodium Fluoride
Dosage FormRinse
Route of AdministrationDENTAL
Marketing Start Date2011-01-12
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameColgate Oral Pharmaceuticals, Inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength2 mg/10mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0126-0135-46

500 mL in 1 BOTTLE (0126-0135-46)
Marketing Start Date2011-01-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0126-0135-16 [00126013516]

Phos-Flur Ortho Defense RINSE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart355
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-01-12
Marketing End Date2015-12-23

NDC 0126-0135-46 [00126013546]

Phos-Flur Ortho Defense RINSE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-01-12
Marketing End Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE2 mg/10mL

OpenFDA Data

SPL SET ID:4ca1ffec-6348-4096-be9d-1232ccdba405
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1233862
  • 831877

    • NDC Crossover Matching brand name "Phos-Flur Ortho Defense" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    0126-0135Phos-Flur Ortho DefenseSODIUM FLUORIDE
    0126-0138Phos-Flur Ortho DefenseSODIUM FLUORIDE
    0126-0139Phos-Flur Ortho DefenseSODIUM FLUORIDE
    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
    0126-0074PrevidDent 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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