NDC 58578-0749

CloSYS

Sodium Fluoride

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

Product ID58578-0749_79ef0664-7b40-6f38-e053-2a91aa0a366c
NDC58578-0749
Product TypeHuman Otc Drug
Proprietary NameCloSYS
Generic NameSodium Fluoride
Dosage FormPaste, Dentifrice
Route of AdministrationDENTAL; ORAL
Marketing Start Date2017-10-20
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameRowpar Pharmaceuticals, Inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength1 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58578-0749-1

1 TUBE in 1 BOX (58578-0749-1) > 96 g in 1 TUBE
Marketing Start Date2017-10-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58578-0749-1 [58578074901]

CloSYS PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-20

NDC 58578-0749-2 [58578074902]

CloSYS PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-20

NDC 58578-0749-3 [58578074903]

CloSYS PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-20

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE1.1 mg/g

OpenFDA Data

SPL SET ID:5f87abb7-0e9d-6369-e053-2a91aa0a2411
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 416783

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

    NDCBrand NameGeneric Name
    58578-0729CloSYSCloSYS
    58578-0749CloSYSCloSYS
    58578-0759CloSYSCloSYS
    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
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