NDC 51289-400

Fluoride Gel

Sodium Fluoride

Fluoride Gel is a Dental Paste in the Human Otc Drug category. It is labeled and distributed by Yangzhou Hengyuan Daily Chemical Plastic Co.,ltd. The primary component is Sodium Fluoride.

Product ID51289-400_37083c7b-abe9-5cd6-e054-00144ff8d46c
NDC51289-400
Product TypeHuman Otc Drug
Proprietary NameFluoride Gel
Generic NameSodium Fluoride
Dosage FormPaste
Route of AdministrationDENTAL
Marketing Start Date2015-05-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameYangzhou Hengyuan Daily Chemical Plastic Co.,Ltd
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 g/100g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 51289-400-05

1000 TUBE in 1 BOX (51289-400-05) > 7 g in 1 TUBE
Marketing Start Date2015-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51289-400-01 [51289040001]

Fluoride Gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-05-25
Inactivation Date2020-01-31

NDC 51289-400-02 [51289040002]

Fluoride Gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-05-25
Inactivation Date2020-01-31

NDC 51289-400-03 [51289040003]

Fluoride Gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-03-07
Inactivation Date2020-01-31

NDC 51289-400-05 [51289040005]

Fluoride Gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-01
Inactivation Date2020-01-31

NDC 51289-400-04 [51289040004]

Fluoride Gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.22 g/100g

OpenFDA Data

SPL SET ID:33ab7045-39e6-3066-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245598
  • NDC Crossover Matching brand name "Fluoride Gel" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    71035-400Fluoride GelFluoride Gel
    51289-400Fluoride GelFluoride Gel
    73343-002Fluoride GelFluoride Gel
    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.