NDC 43498-250

Burkhart

Stannous Fluoride

Burkhart is a Dental Gel in the Human Otc Drug category. It is labeled and distributed by Burkhart Dental Supply Inc. The primary component is Stannous Fluoride.

Product ID43498-250_8b360da0-0063-454b-9bfb-af43cf2d00ca
NDC43498-250
Product TypeHuman Otc Drug
Proprietary NameBurkhart
Generic NameStannous Fluoride
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2013-01-05
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameBurkhart Dental Supply Inc
Substance NameSTANNOUS FLUORIDE
Active Ingredient Strength0 g/120g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43498-250-04

120 g in 1 TUBE (43498-250-04)
Marketing Start Date2013-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43498-250-04 [43498025004]

Burkhart GEL
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-09-01

Drug Details

Active Ingredients

IngredientStrength
STANNOUS FLUORIDE.116 g/120g

OpenFDA Data

SPL SET ID:048c9978-e32e-4f77-9a4e-40acd5fcdfaf
Manufacturer
UNII

NDC Crossover Matching brand name "Burkhart" or generic name "Stannous Fluoride"

NDCBrand NameGeneric Name
43498-108BurkhartBurkhart
43498-103BurkhartBurkhart
43498-106BurkhartBurkhart
43498-109BurkhartBurkhart
43498-104BurkhartBurkhart
43498-100BurkhartBurkhart
43498-200BurkhartBurkhart
43498-102BurkhartBurkhart
43498-105BurkhartBurkhart
43498-107BurkhartBurkhart
43498-101BurkhartBurkhart
43498-201BurkhartBurkhart
43498-250BurkhartBurkhart
43498-251BurkhartBurkhart
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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