NDC 48783-520

Enamelon

Stannous Fluoride

Enamelon is a Dental Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Premier Dental Products Company. The primary component is Stannous Fluoride.

Product ID48783-520_503bfe9b-75f3-4aaa-8e1c-16a91853af96
NDC48783-520
Product TypeHuman Otc Drug
Proprietary NameEnamelon
Generic NameStannous Fluoride
Dosage FormPaste, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2014-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NamePremier Dental Products Company
Substance NameSTANNOUS FLUORIDE
Active Ingredient Strength0 g/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 48783-520-08

1 TUBE in 1 CARTON (48783-520-08) > 21.2 g in 1 TUBE
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 48783-520-43 [48783052043]

Enamelon PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-01

NDC 48783-520-08 [48783052008]

Enamelon PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-01

Drug Details

Active Ingredients

IngredientStrength
STANNOUS FLUORIDE.00454 g/g

OpenFDA Data

SPL SET ID:1626375a-f78b-4192-b7f3-ca932acab7fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 416784

    • NDC Crossover Matching brand name "Enamelon" or generic name "Stannous Fluoride"

    NDCBrand NameGeneric Name
    48783-520EnamelonEnamelon
    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 [Enamelon]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ENAMELON
    ENAMELON
    86107188 not registered Dead/Abandoned
    Premier Dental Products Company
    2013-10-31
    ENAMELON
    ENAMELON
    78713734 3833080 Dead/Cancelled
    200 Kelsey Associates, LLC
    2005-09-15
    ENAMELON
    ENAMELON
    77720752 4621342 Live/Registered
    Premier Dental Products Company
    2009-04-23
    ENAMELON
    ENAMELON
    75703942 not registered Dead/Abandoned
    Enamelon, Inc.
    1999-05-11
    ENAMELON
    ENAMELON
    75640682 not registered Dead/Abandoned
    Enamelon, Inc.
    1999-02-12
    ENAMELON
    ENAMELON
    75640681 not registered Dead/Abandoned
    Enamelon, Inc.
    1999-02-12
    ENAMELON
    ENAMELON
    75640677 2296210 Dead/Cancelled
    Enamelon, Inc.
    1999-02-12
    ENAMELON
    ENAMELON
    75640676 2296209 Dead/Cancelled
    Enamelon, Inc.
    1999-02-12
    ENAMELON
    ENAMELON
    75417630 not registered Dead/Abandoned
    Enamelon, Inc.
    1998-01-14
    ENAMELON
    ENAMELON
    75023365 not registered Dead/Abandoned
    Enamelon, Inc.
    1995-11-22
    ENAMELON
    ENAMELON
    74801538 2091936 Dead/Cancelled
    Enamelon, Inc.
    1992-12-15
    ENAMELON
    ENAMELON
    74450714 not registered Dead/Abandoned
    Enamelon, Inc.
    1993-10-04
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