NDC 0135-0577

biotene

Sodium Monofluorophosphate

biotene is a Oral Paste in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Sodium Monofluorophosphate.

Product ID0135-0577_517f89aa-dd25-44de-ae8e-824379ca0c28
NDC0135-0577
Product TypeHuman Otc Drug
Proprietary Namebiotene
Generic NameSodium Monofluorophosphate
Dosage FormPaste
Route of AdministrationORAL
Marketing Start Date2016-09-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameSODIUM MONOFLUOROPHOSPHATE
Active Ingredient Strength1 mg/g
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0135-0577-01

1 TUBE in 1 CARTON (0135-0577-01) > 121.9 g in 1 TUBE
Marketing Start Date2016-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0135-0577-01 [00135057701]

biotene PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-09-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.4 mg/g

OpenFDA Data

SPL SET ID:a47a6502-efb2-4072-9562-cbe293531c2b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 545626

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

    NDCBrand NameGeneric Name
    0135-0487BIOTENEsodium monofluorophosphate
    0135-0557BIOTENEsodium fluoride
    0135-0558BIOTENEsodium fluoride
    0135-0577biotenesodium monofluorophosphate
    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
    35000-135CO Oh So Dazzling Sweet MintSODIUM MONOFLUOROPHOSPHATE
    35000-916ColgateSODIUM MONOFLUOROPHOSPHATE
    35000-919ColgateSODIUM MONOFLUOROPHOSPHATE
    35000-929COLGATESODIUM MONOFLUOROPHOSPHATE
    0126-0027Colgate Cavity ProtectionSodium Monofluorophosphate
    35000-257COLGATE Great Regular FlavorSODIUM MONOFLUOROPHOSPHATE
    35000-913COLGATE Great Regular FlavorSODIUM MONOFLUOROPHOSPHATE
    35000-934Colgate Optic White Beauty RadiantSODIUM MONOFLUOROPHOSPHATE
    35000-925Colgate Optic White High Impact 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 [biotene]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BIOTENE
    BIOTENE
    87463758 not registered Live/Pending
    GlaxoSmithKline Consumer Healthcare (US) IP LLC
    2017-05-25
    BIOTENE
    BIOTENE
    85823689 4376505 Live/Registered
    GLAXOSMITHKLINE CONSUMER HEALTHCARE (US)
    2013-01-15
    BIOTENE
    BIOTENE
    75194938 2300272 Dead/Cancelled
    Graymills Corporation
    1996-11-08
    BIOTENE
    BIOTENE
    74231821 1739407 Live/Registered
    GLAXOSMITHKLINE CONSUMER HEALTHCARE (US) IP LLC
    1991-12-19
    BIOTENE
    BIOTENE
    74151030 1676537 Live/Registered
    EGGLAND'S BEST, LLC
    1991-03-25
    BIOTENE
    BIOTENE
    73463315 1329910 Live/Registered
    Laclede Professional Products, Inc.
    1984-01-30
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