NDC 58578-1234

CloSYS Fluoride Rinse

Sodium Fluoride

CloSYS Fluoride Rinse is a Oral Rinse in the Human Otc Drug category. It is labeled and distributed by Rowpar Pharmaceuticals, Inc.. The primary component is Sodium Fluoride.

Product ID58578-1234_3c5cd3d1-36e9-43d5-8f6d-cece42609efd
NDC58578-1234
Product TypeHuman Otc Drug
Proprietary NameCloSYS Fluoride Rinse
Generic NameSodium Fluoride
Dosage FormRinse
Route of AdministrationORAL
Marketing Start Date2016-02-18
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameRowpar Pharmaceuticals, Inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 g/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58578-1234-1

1 BOTTLE in 1 BOX (58578-1234-1) > 473 mL in 1 BOTTLE
Marketing Start Date2016-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58578-1234-1 [58578123401]

CloSYS Fluoride Rinse RINSE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-18

NDC 58578-1234-2 [58578123402]

CloSYS Fluoride Rinse RINSE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-18

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.05 g/100mL

OpenFDA Data

SPL SET ID:1a994f24-99ee-4b27-aab0-e816931a22c8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 240698
    • UPC Code
  • 0647692227010

    • NDC Crossover Matching brand name "CloSYS Fluoride Rinse" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    58578-1234CloSYS Fluoride RinseCloSYS Fluoride 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

    Trademark Results [CloSYS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CLOSYS
    CLOSYS
    88541180 not registered Live/Pending
    ROWPAR PHARMACEUTICALS, INC.
    2019-07-26
    CLOSYS
    CLOSYS
    88541166 not registered Live/Pending
    ROWPAR PHARMACEUTICALS, INC.
    2019-07-26
    CLOSYS
    CLOSYS
    86001673 4610938 Live/Registered
    Closys Corporation
    2013-07-03
    CLOSYS
    CLOSYS
    85013967 not registered Dead/Abandoned
    Closys Corporation
    2010-04-14
    CLOSYS
    CLOSYS
    79052710 3509051 Dead/Cancelled
    AROL S.p.A.
    2008-02-06
    CLOSYS
    CLOSYS
    78918668 3309871 Live/Registered
    Rowpar Pharmaceuticals, Inc.
    2006-06-28
    CLOSYS
    CLOSYS
    78909749 not registered Dead/Abandoned
    Closys Corporation
    2006-06-16
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.