NDC 53050-011

Ora 2 stain clear

Sodium Fluoride

Ora 2 stain clear is a Dental Paste in the Human Otc Drug category. It is labeled and distributed by Sunstar Guangzhou Ltd.. The primary component is Sodium Fluoride.

Product ID53050-011_68e9f68c-5348-389e-e053-2a91aa0ae773
NDC53050-011
Product TypeHuman Otc Drug
Proprietary NameOra 2 stain clear
Generic NameSodium Fluoride
Dosage FormPaste
Route of AdministrationDENTAL
Marketing Start Date2012-08-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameSunstar Guangzhou Ltd.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 g/100g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53050-011-03

5 g in 1 TUBE (53050-011-03)
Marketing Start Date2017-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53050-011-03 [53050001103]

Ora 2 stain clear PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-04-01
Marketing End Date2020-03-06

NDC 53050-011-02 [53050001102]

Ora 2 stain clear PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-04-01
Marketing End Date2020-03-06

NDC 53050-011-01 [53050001101]

Ora 2 stain clear PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-04-05
Marketing End Date2020-03-06

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.1 g/100g

OpenFDA Data

SPL SET ID:68e9f68c-5347-389e-e053-2a91aa0ae773
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 435191

    • NDC Crossover Matching brand name "Ora 2 stain clear" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    53050-001Ora 2 stain clearOra 2 stain clear
    53050-011Ora 2 stain clearOra 2 stain clear
    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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