NDC 61578-204

CTx4 Gel 1100 Citrus

Sodium Fluoride

CTx4 Gel 1100 Citrus is a Dental Gel, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Oral Biotech. The primary component is Sodium Fluoride.

Product ID61578-204_44cbd3db-47a6-4030-a1c0-851a8494516b
NDC61578-204
Product TypeHuman Otc Drug
Proprietary NameCTx4 Gel 1100 Citrus
Generic NameSodium Fluoride
Dosage FormGel, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2012-05-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameOral BioTech
Substance NameSODIUM FLUORIDE
Active Ingredient Strength1100 ug/g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61578-204-01

56.699 g in 1 TUBE, WITH APPLICATOR (61578-204-01)
Marketing Start Date2012-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61578-204-01 [61578020401]

CTx4 Gel 1100 Citrus GEL, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-05-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE1100 ug/g

OpenFDA Data

SPL SET ID:244e1894-4b82-4246-b6d9-2269257495b7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 416783

    • NDC Crossover Matching brand name "CTx4 Gel 1100 Citrus" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    61578-204CTx4 Gel 1100 CitrusCTx4 Gel 1100 Citrus
    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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