NDC 0135-0590

AQUAFRESH CAVITY PROTECTION

Sodium Fluoride

AQUAFRESH CAVITY PROTECTION is a Dental 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 ID0135-0590_406bcedb-ab48-4b75-8e0a-0fa02064deda
NDC0135-0590
Product TypeHuman Otc Drug
Proprietary NameAQUAFRESH CAVITY PROTECTION
Generic NameSodium Fluoride
Dosage FormPaste
Route of AdministrationDENTAL
Marketing Start Date2016-10-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameSODIUM FLUORIDE
Active Ingredient Strength1 mg/g
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0135-0590-01

1 TUBE in 1 CARTON (0135-0590-01) > 158.8 g in 1 TUBE
Marketing Start Date2016-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0135-0590-04 [00135059004]

AQUAFRESH CAVITY PROTECTION PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-11-01

NDC 0135-0590-01 [00135059001]

AQUAFRESH CAVITY PROTECTION PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-01

NDC 0135-0590-02 [00135059002]

AQUAFRESH CAVITY PROTECTION PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-11-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE1.15 mg/g

OpenFDA Data

SPL SET ID:5484999c-8e6f-430d-99a5-6893a2489467
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1044547

    • NDC Crossover Matching brand name "AQUAFRESH CAVITY PROTECTION" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    0135-0590AQUAFRESH CAVITY PROTECTIONAQUAFRESH CAVITY PROTECTION
    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 [AQUAFRESH]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AQUAFRESH
    AQUAFRESH
    86552488 not registered Dead/Abandoned
    Inman, Nick
    2015-03-04
    AQUAFRESH
    AQUAFRESH
    85044552 not registered Dead/Abandoned
    GlaxoSmithKline LLC
    2010-05-21
    AQUAFRESH
    AQUAFRESH
    78460244 2929043 Dead/Cancelled
    GLAXOSMITHKLINE LLC
    2004-08-02
    AQUAFRESH
    AQUAFRESH
    78448194 2985544 Live/Registered
    GLAXOSMITHKLINE CONSUMER HEALTHCARE (US) IP LLC
    2004-07-09
    AQUAFRESH
    AQUAFRESH
    78385905 2935093 Dead/Cancelled
    GLAXOSMITHKLINE LLC
    2004-03-17
    AQUAFRESH
    AQUAFRESH
    78027834 not registered Dead/Abandoned
    Valterra Products, Inc.
    2000-09-27
    AQUAFRESH
    AQUAFRESH
    76242063 2706176 Live/Registered
    GLAXOSMITHKLINE CONSUMER HEALTHCARE (US) IP LLC
    2001-04-17
    AQUAFRESH
    AQUAFRESH
    76241924 2699482 Dead/Cancelled
    SmithKline Beecham Corporation
    2001-04-17
    AQUAFRESH
    AQUAFRESH
    76241913 2706175 Live/Registered
    GLAXOSMITHKLINE CONSUMER HEALTHCARE (US) IP LLC
    2001-04-17
    AQUAFRESH
    AQUAFRESH
    76035013 2754841 Live/Registered
    GLAXOSMITHKLINE CONSUMER HEALTHCARE (US) IP LLC
    2000-04-21
    AQUAFRESH
    AQUAFRESH
    75914718 2503053 Dead/Cancelled
    SmithKline Beecham Corporation
    2000-02-10
    AQUAFRESH
    AQUAFRESH
    75914704 2503052 Dead/Cancelled
    SmithKline Beecham Corporation
    2000-02-10
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