NDC 58578-0759

CloSYS

Sodium Fluoride

CloSYS is a 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 ID58578-0759_6d54e12b-51a5-40e8-91f9-cee40d740e71
NDC58578-0759
Product TypeHuman Otc Drug
Proprietary NameCloSYS
Generic NameSodium Fluoride
Dosage FormPaste, Dentifrice
Route of AdministrationORAL
Marketing Start Date2020-01-06
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 58578-0759-1

1 TUBE in 1 BOX (58578-0759-1) > 96 g in 1 TUBE
Marketing Start Date2020-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58578-0759-2 [58578075902]

CloSYS PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-06

NDC 58578-0759-1 [58578075901]

CloSYS PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-06

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.916 mg/g

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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