NDC 61041-212

XEROSTOM

Sodium Fluoride

XEROSTOM is a Oral Paste in the Human Otc Drug category. It is labeled and distributed by Bio Cosmetics S L. The primary component is Sodium Fluoride.

Product ID61041-212_00a25149-f05f-4629-9cad-e44790963fa1
NDC61041-212
Product TypeHuman Otc Drug
Proprietary NameXEROSTOM
Generic NameSodium Fluoride
Dosage FormPaste
Route of AdministrationORAL
Marketing Start Date2015-02-06
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameBio Cosmetics S L
Substance NameSODIUM FLUORIDE
Active Ingredient Strength2 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61041-212-03

6.5 g in 1 PACKET (61041-212-03)
Marketing Start Date2015-02-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61041-212-03 [61041021203]

XEROSTOM PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-02-06

NDC 61041-212-01 [61041021201]

XEROSTOM PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-11-08

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE2.2 mg/g

OpenFDA Data

SPL SET ID:7a28836b-8414-4ac8-a283-cdb989a9d167
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245598
    • UPC Code
  • 8426181972752

    • NDC Crossover Matching brand name "XEROSTOM" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    61041-211XEROSTOMXEROSTOM
    61041-212XEROSTOMXEROSTOM
    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

    Trademark Results [XEROSTOM]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XEROSTOM
    XEROSTOM
    78274022 2869566 Live/Registered
    Bio Cosmetics, S.L.
    2003-07-14
    XEROSTOM
    XEROSTOM
    78162753 2824989 Live/Registered
    Bio Cosmetics, S.L.
    2002-09-11
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