NDC 43498-103

Burkhart

Sodium Fluoride

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

Product ID43498-103_7a5b826d-142a-4535-bb81-55c2670adff0
NDC43498-103
Product TypeHuman Prescription Drug
Proprietary NameBurkhart
Generic NameSodium Fluoride
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2012-12-14
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameBurkhart Dental Supply Inc
Substance NameSODIUM FLUORIDE
Active Ingredient Strength6 g/454g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43498-103-15

454 g in 1 BOTTLE, PLASTIC (43498-103-15)
Marketing Start Date2013-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43498-103-15 [43498010315]

Burkhart GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE5.6 g/454g

OpenFDA Data

SPL SET ID:79fa0a42-bb69-49db-9997-1679a75bac26
Manufacturer
UNII

NDC Crossover Matching brand name "Burkhart" or generic name "Sodium 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
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

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