NDC 59883-821

Pro-Den Rx

Sodium Fluoride

Pro-Den Rx is a Oral Gel in the Human Otc Drug category. It is labeled and distributed by Den-mat Holdings, Llc. The primary component is Sodium Fluoride.

Product ID59883-821_8349a34e-ac6f-79c3-e053-2a91aa0a857a
NDC59883-821
Product TypeHuman Otc Drug
Proprietary NamePro-Den Rx
Generic NameSodium Fluoride
Dosage FormGel
Route of AdministrationORAL
Marketing Start Date2008-11-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameDEN-MAT HOLDINGS, LLC
Substance NameSODIUM FLUORIDE
Active Ingredient Strength4 g/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59883-821-02

1 TUBE in 1 CARTON (59883-821-02) > 56 g in 1 TUBE
Marketing Start Date2008-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59883-821-02 [59883082102]

Pro-Den Rx GEL
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-11-21

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE4.3 g/g

OpenFDA Data

SPL SET ID:bcda408e-4e54-4909-aae6-97b26b40830b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 392038
  • 1101883

    • NDC Crossover Matching brand name "Pro-Den Rx" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    59883-820Pro-Den RxPro-Den Rx
    59883-824Pro-Den RxPro-Den Rx
    59883-720Pro-Den RxPro-Den Rx
    59883-821Pro-Den RxPro-Den Rx
    59883-912Pro-Den RxPro-Den Rx
    59883-168Pro-Den RxPro-Den Rx
    59883-911Pro-Den RxPro-Den Rx
    59883-920Pro-Den RxPro-Den Rx
    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.