NDC 0135-0547

SENSODYNE Repair and Protect Extra Fresh

Stannous Fluoride

SENSODYNE Repair and Protect Extra Fresh 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 Stannous Fluoride.

Product ID0135-0547_3dec0f2d-e250-4b6d-9240-b6327a1dca51
NDC0135-0547
Product TypeHuman Otc Drug
Proprietary NameSENSODYNE Repair and Protect Extra Fresh
Generic NameStannous Fluoride
Dosage FormPaste
Route of AdministrationORAL
Marketing Start Date2021-06-28
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameSTANNOUS FLUORIDE
Active Ingredient Strength1 mg/g
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0135-0547-02

1 TUBE in 1 CARTON (0135-0547-02) > 96.4 g in 1 TUBE
Marketing Start Date2021-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0135-0547-02 [00135054702]

SENSODYNE Repair and Protect Extra Fresh PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-02-04

Drug Details

Active Ingredients

IngredientStrength
STANNOUS FLUORIDE1.1 mg/g

OpenFDA Data

SPL SET ID:34260c69-d829-46c0-b12a-5136ee073ba1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 416784

    • NDC Crossover Matching brand name "SENSODYNE Repair and Protect Extra Fresh" or generic name "Stannous Fluoride"

    NDCBrand NameGeneric Name
    0126-0165Gel-Kam Fruit and BerryStannous Fluoride
    0126-0192Gel-Kam MintStannous Fluoride
    0135-0598parodontaxstannous fluoride
    0135-0599parodontaxstannous fluoride
    0135-0601parodontaxstannous fluoride
    0135-0547SENSODYNEstannous fluoride
    0135-0548SENSODYNEstannous fluoride
    0135-0575SENSODYNEstannous fluoride
    0135-0621SENSODYNEstannous fluoride
    0135-0622SENSODYNEstannous fluoride
    0135-0572Sensodyne Complete Protectionstannous fluoride
    0135-0573Sensodyne Complete Protectionstannous fluoride

    Trademark Results [SENSODYNE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SENSODYNE
    SENSODYNE
    97652079 not registered Live/Pending
    Block Drug Company, Inc.
    2022-10-28
    SENSODYNE
    SENSODYNE
    90542698 not registered Live/Pending
    Block Drug Company, Inc.
    2021-02-23
    SENSODYNE
    SENSODYNE
    90541828 not registered Live/Pending
    Block Drug Company, Inc.
    2021-02-23
    SENSODYNE
    SENSODYNE
    90375748 not registered Live/Pending
    Block Drug Company, Inc.
    2020-12-11
    SENSODYNE
    SENSODYNE
    90068948 not registered Live/Pending
    Stafford-Miller (Ireland) Limited
    2020-07-23
    SENSODYNE
    SENSODYNE
    90068933 not registered Live/Pending
    Stafford-Miller (Ireland) Limited
    2020-07-23
    SENSODYNE
    SENSODYNE
    85737852 4482097 Live/Registered
    GlaxoSmithKline LLC
    2012-09-25
    SENSODYNE
    SENSODYNE
    78733418 3428309 Live/Registered
    BLOCK DRUG COMPANY, INC.
    2005-10-14
    SENSODYNE
    SENSODYNE
    78084878 not registered Dead/Abandoned
    Dentco, Inc.
    2001-09-21
    SENSODYNE
    SENSODYNE
    77165130 3441885 Live/Registered
    BLOCK DRUG COMPANY, INC.
    2007-04-25
    SENSODYNE
    SENSODYNE
    77119656 not registered Dead/Abandoned
    Block Drug Company, Inc.
    2007-03-01
    SENSODYNE
    SENSODYNE
    76268954 2630956 Dead/Cancelled
    SMITHKLINE BEECHAM CORPORATION
    2001-06-08
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.