NDC 61041-211

XEROSTOM

Sodium Fluoride

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

Product ID61041-211_07ceb03e-9994-498c-a020-d7f17f9da10b
NDC61041-211
Product TypeHuman Otc Drug
Proprietary NameXEROSTOM
Generic NameSodium Fluoride
Dosage FormMouthwash
Route of AdministrationORAL
Marketing Start Date2013-11-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameBio Cosmetics
Substance NameSODIUM FLUORIDE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 61041-211-09

1 BOTTLE in 1 CARTON (61041-211-09) > 250 mL in 1 BOTTLE
Marketing Start Date2013-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61041-211-09 [61041021109]

XEROSTOM MOUTHWASH
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-11-15

NDC 61041-211-31 [61041021131]

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

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.559 mg/mL

OpenFDA Data

SPL SET ID:28a1a9c9-9c9a-4e43-b12c-85ded19ed926
Manufacturer
UNII

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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