NDC 35573-435

Sodium Fluoride 1.1%

Sodium Fluoride

Sodium Fluoride 1.1% is a Dental Gel, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Burel Pharmaceuticals Llc. The primary component is Sodium Fluoride.

Product ID35573-435_0de90332-2887-482b-8787-1fbbc6500c00
NDC35573-435
Product TypeHuman Prescription Drug
Proprietary NameSodium Fluoride 1.1%
Generic NameSodium Fluoride
Dosage FormGel, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2020-02-28
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameBurel Pharmaceuticals LLC
Substance NameSODIUM FLUORIDE
Active Ingredient Strength5 mg/g
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 35573-435-56

1 TUBE in 1 CARTON (35573-435-56) > 56 g in 1 TUBE
Marketing Start Date2020-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35573-435-56 [35573043556]

Sodium Fluoride 1.1% GEL, DENTIFRICE
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2020-02-28

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE5 mg/g

NDC Crossover Matching brand name "Sodium Fluoride 1.1%" or generic name "Sodium Fluoride"

NDCBrand NameGeneric Name
35573-435Sodium Fluoride 1.1%Sodium Fluoride 1.1%
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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