NDC 0135-0558

BIOTENE Gentle Mint

Sodium Fluoride

BIOTENE Gentle Mint 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 Fluoride.

Product ID0135-0558_3033b740-6281-4439-b9b5-16ea97652940
NDC0135-0558
Product TypeHuman Otc Drug
Proprietary NameBIOTENE Gentle Mint
Generic NameSodium Fluoride
Dosage FormPaste
Route of AdministrationORAL
Marketing Start Date2013-07-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameSODIUM FLUORIDE
Active Ingredient Strength2 mg/g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0135-0558-01

1 TUBE in 1 CARTON (0135-0558-01) > 121.9 g in 1 TUBE
Marketing Start Date2013-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0135-0558-01 [00135055801]

BIOTENE Gentle Mint PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-07-15

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE1.5 mg/g

OpenFDA Data

SPL SET ID:1101c17f-c848-4cd5-a7cd-679b59dbe1bf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1044547
  • 416783

    • NDC Crossover Matching brand name "BIOTENE Gentle Mint" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    0135-0558BIOTENE Gentle MintBIOTENE Gentle Mint
    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 [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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