NDC 72551-246

TheraBreath Healthy Smile Oral Rinse

Sodium Fluoride

TheraBreath Healthy Smile Oral Rinse is a Oral Rinse in the Human Otc Drug category. It is labeled and distributed by Dr. Harold Katz, Llc. The primary component is Sodium Fluoride.

Product ID72551-246_847721d3-46f5-f068-e053-2a91aa0add11
NDC72551-246
Product TypeHuman Otc Drug
Proprietary NameTheraBreath Healthy Smile Oral Rinse
Generic NameSodium Fluoride
Dosage FormRinse
Route of AdministrationORAL
Marketing Start Date2018-10-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameDr. Harold Katz, LLC
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 g/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72551-246-01

473 g in 1 BOTTLE, PLASTIC (72551-246-01)
Marketing Start Date2019-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72551-246-03 [72551024603]

TheraBreath Healthy Smile Oral Rinse RINSE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-03-19

NDC 72551-246-02 [72551024602]

TheraBreath Healthy Smile Oral Rinse RINSE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-01

NDC 72551-246-01 [72551024601]

TheraBreath Healthy Smile Oral Rinse RINSE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.0005 g/g

OpenFDA Data

SPL SET ID:7f0e6864-5577-e368-e053-2a91aa0a57ca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 240698
  • NDC Crossover Matching brand name "TheraBreath Healthy Smile Oral Rinse" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    72551-246TheraBreath Healthy Smile Oral RinseTheraBreath Healthy Smile Oral Rinse
    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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