NDC 61578-205

CTx4 Gel 5000 Mint

Sodium Fluoride

CTx4 Gel 5000 Mint is a Dental Gel, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Oral Biotech. The primary component is Sodium Fluoride.

Product ID61578-205_08101317-6b6b-4243-8e77-19f151f4b856
NDC61578-205
Product TypeHuman Prescription Drug
Proprietary NameCTx4 Gel 5000 Mint
Generic NameSodium Fluoride
Dosage FormGel, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2012-05-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameOral BioTech
Substance NameSODIUM FLUORIDE
Active Ingredient Strength5000 ug/g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61578-205-01

56.699 g in 1 TUBE, WITH APPLICATOR (61578-205-01)
Marketing Start Date2022-05-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61578-205-01 [61578020501]

CTx4 Gel 5000 Mint GEL, DENTIFRICE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-05-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE5000 ug/g

OpenFDA Data

SPL SET ID:56321686-b62d-4971-88d7-064d84d349d3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1486572
  • 1486566

    • NDC Crossover Matching brand name "CTx4 Gel 5000 Mint" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    61578-205CTx4 Gel 5000 MintCTx4 Gel 5000 Mint
    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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