NDC 48783-500

Enamelon Preventive Treatment

Stannous Fluoride

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

Product ID48783-500_1669758f-6982-45d9-a8e1-1a87b293d2ed
NDC48783-500
Product TypeHuman Otc Drug
Proprietary NameEnamelon Preventive Treatment
Generic NameStannous Fluoride
Dosage FormGel
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 Through2020-12-31

Packaging

NDC 48783-500-40

1 TUBE in 1 CARTON (48783-500-40) > 113 g in 1 TUBE
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 48783-500-40 [48783050040]

Enamelon Preventive Treatment GEL
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-01

Drug Details

Active Ingredients

IngredientStrength
STANNOUS FLUORIDE.004 g/g

OpenFDA Data

SPL SET ID:04c3f178-7905-404d-9ac2-67c453287ddf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 237847
  • NDC Crossover Matching brand name "Enamelon Preventive Treatment" or generic name "Stannous Fluoride"

    NDCBrand NameGeneric Name
    48783-500Enamelon Preventive TreatmentEnamelon Preventive Treatment
    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

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