NDC 57367-033

THERABREATH TOOTHPASTE

Sodium Fluoride

THERABREATH TOOTHPASTE is a Dental Gel, Dentifrice in the Human Otc Drug category. It is labeled and distributed by 220 Laboratories Inc. The primary component is Sodium Fluoride.

Product ID57367-033_3cc1078d-c61a-4b3c-877f-e0cbb6e7b9e7
NDC57367-033
Product TypeHuman Otc Drug
Proprietary NameTHERABREATH TOOTHPASTE
Generic NameSodium Fluoride
Dosage FormGel, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2010-03-03
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler Name220 LABORATORIES INC
Substance NameSODIUM FLUORIDE
Active Ingredient Strength24 mg/10g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57367-033-18

113.5 g in 1 TUBE (57367-033-18)
Marketing Start Date2010-03-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57367-033-18 [57367003318]

THERABREATH TOOTHPASTE GEL, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-03-03
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE24 mg/10g

OpenFDA Data

SPL SET ID:bcb43ec7-5ef2-4a37-8a3c-1895cea58c36
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 416783

    • NDC Crossover Matching brand name "THERABREATH TOOTHPASTE" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    57367-033THERABREATH TOOTHPASTETHERABREATH TOOTHPASTE
    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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.