NDC 69939-323

Orbitol

Sodium Monofluorophosphate

Orbitol is a Topical Paste in the Human Otc Drug category. It is labeled and distributed by Cosmopharm Ltd.. The primary component is Sodium Monofluorophosphate.

Product ID69939-323_40c5a555-8a66-4b98-9091-4a0ae921b9b9
NDC69939-323
Product TypeHuman Otc Drug
Proprietary NameOrbitol
Generic NameSodium Monofluorophosphate
Dosage FormPaste
Route of AdministrationTOPICAL
Marketing Start Date2016-02-08
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameCOSMOPHARM LTD.
Substance NameSODIUM MONOFLUOROPHOSPHATE
Active Ingredient Strength1 g/100g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69939-323-02

145 g in 1 TUBE (69939-323-02)
Marketing Start Date2016-02-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69939-323-03 [69939032303]

Orbitol PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-08
Marketing End Date2016-02-24

NDC 69939-323-02 [69939032302]

Orbitol PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-08
Marketing End Date2019-09-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.74 g/100g

OpenFDA Data

SPL SET ID:d9d86dbd-ade5-4d49-947b-f616c0d3629d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1737795

    • NDC Crossover Matching brand name "Orbitol" or generic name "Sodium Monofluorophosphate"

    NDCBrand NameGeneric Name
    69939-310OrbitolOrbitol
    69939-306OrbitolOrbitol
    69939-309OrbitolOrbitol
    69939-311OrbitolOrbitol
    69939-313OrbitolOrbitol
    69939-323OrbitolOrbitol
    29500-0819ADVANCED FLUORIDE ANTICAVITYSODIUM MONOFLUOROPHOSPHATE
    29500-9181ADVANCED FLUORIDE ANTICAVITYSODIUM MONOFLUOROPHOSPHATE
    29500-2238Advanced Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATE
    29500-9223Advanced Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATE
    0135-0619Aquafreshsodium monofluorophosphate
    0135-0487BIOTENEsodium monofluorophosphate
    0135-0577biotenesodium monofluorophosphate
    35000-135CO Oh So Dazzling Sweet MintSODIUM MONOFLUOROPHOSPHATE
    35000-916ColgateSODIUM MONOFLUOROPHOSPHATE
    35000-919ColgateSODIUM MONOFLUOROPHOSPHATE
    35000-929COLGATESODIUM MONOFLUOROPHOSPHATE
    35000-959COLGATESODIUM MONOFLUOROPHOSPHATE
    35000-960ColgateSODIUM MONOFLUOROPHOSPHATE
    0126-0027Colgate Cavity ProtectionSodium Monofluorophosphate
    35000-257COLGATE Great Regular FlavorSODIUM MONOFLUOROPHOSPHATE
    35000-913COLGATE Great Regular FlavorSODIUM MONOFLUOROPHOSPHATE
    35000-961Colgate Optic WhiteSODIUM MONOFLUOROPHOSPHATE
    35000-934Colgate Optic White Beauty RadiantSODIUM MONOFLUOROPHOSPHATE
    35000-925Colgate Optic White High Impact FluorideSODIUM MONOFLUOROPHOSPHATE
    35000-951Colgate Optic White PlatinumSODIUM MONOFLUOROPHOSPHATE
    35000-952Colgate Optic White Platinum Anticavity FluorideSODIUM MONOFLUOROPHOSPHATE
    35000-747Colgate Optic White Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATE
    35000-748Colgate Optic White ProSeries Enamel StrenghtSODIUM MONOFLUOROPHOSPHATE
    35000-749Colgate Optic White ProSeries Vividly FreshSODIUM MONOFLUOROPHOSPHATE
    35000-758Colgate Optic White SparklingSODIUM MONOFLUOROPHOSPHATE
    35000-893Colgate Optic White Stain PreventionSODIUM MONOFLUOROPHOSPHATE
    16555-996DENBLANSODIUM MONOFLUOROPHOSPHATE
    10237-673Dude Perfect Fluoride Toothpastes and Spinbrush Combo PackSodium Monofluorophosphate
    21130-417Kids Strawberry FTPSodium Monofluorophosphate
    20276-551Lucky Super SoftSodium monofluorophosphate
    20276-552Lucky Super SoftSodium monofluorophosphate
    20276-553Lucky Super SoftSodium monofluorophosphate
    20276-554Lucky Super SoftSodium monofluorophosphate
    30142-223Natural Adult FluorideSodium monofluorophosphate
    23636-1001NBF GingivalSODIUM MONOFLUOROPHOSPHATE
    0363-2008Ology FluorideSodium Monofluorophosphate
    30142-146Simple TruthSodium Monofluorophosphate

    Trademark Results [Orbitol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ORBITOL
    ORBITOL
    86461128 4844221 Live/Registered
    JS Medimax Inc.
    2014-11-21
    ORBITOL
    ORBITOL
    78941125 3363819 Live/Registered
    Sano-Brunos Enterprises Ltd.
    2006-07-31
    ORBITOL
    ORBITOL
    78355278 2925231 Dead/Cancelled
    Neways, Inc.
    2004-01-21
    ORBITOL
    ORBITOL
    75459086 2253353 Dead/Cancelled
    Neways, Inc.
    1998-03-30
    ORBITOL
    ORBITOL
    71475223 0412999 Dead/Expired
    SINCLAIR REFINING COMPANY
    1944-10-11
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