NDC 59883-031

FLUORIDEX

Sodium Fluoride

FLUORIDEX is a Dental Paste, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Dent-mat Holdings, Llc.. The primary component is Potassium Nitrate; Sodium Fluoride.

Product ID59883-031_740694d0-55c7-154c-e053-2991aa0a3a56
NDC59883-031
Product TypeHuman Prescription Drug
Proprietary NameFLUORIDEX
Generic NameSodium Fluoride
Dosage FormPaste, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2016-12-21
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameDENT-MAT HOLDINGS, LLC.
Substance NamePOTASSIUM NITRATE; SODIUM FLUORIDE
Active Ingredient Strength50 mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59883-031-04

1 TUBE in 1 BOX (59883-031-04) > 112 g in 1 TUBE
Marketing Start Date2016-12-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59883-031-04 [59883003104]

FLUORIDEX PASTE, DENTIFRICE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-12-21

NDC 59883-031-05 [59883003105]

FLUORIDEX PASTE, DENTIFRICE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-22

Drug Details

Active Ingredients

IngredientStrength
POTASSIUM NITRATE50 mg/g

OpenFDA Data

SPL SET ID:601774d5-f4de-01bc-e053-2991aa0a7f4f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 637365
  • 847014
  • NDC Crossover Matching brand name "FLUORIDEX" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    59883-016FLUORIDEXFLUORIDEX
    59883-031FLUORIDEXFLUORIDEX
    59883-004FluoridexFluoridex
    59883-020FLUORIDEXFLUORIDEX
    59883-030FLUORIDEXFLUORIDEX
    59883-015FLUORIDEXFLUORIDEX
    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 [FLUORIDEX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FLUORIDEX
    FLUORIDEX
    75980521 2521163 Live/Registered
    DEN-MAT HOLDINGS, LLC
    1998-07-27
    FLUORIDEX
    FLUORIDEX
    75527076 not registered Dead/Abandoned
    Discus Dental Impressions, Inc.
    1998-07-27

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