NDC 63956-003

Emmi-dent Whitening

Sodium Fluoride

Emmi-dent Whitening is a Dental Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Emag Ag. The primary component is Sodium Fluoride.

Product ID63956-003_21527bb7-b2ba-4c58-998e-7a6a22120feb
NDC63956-003
Product TypeHuman Otc Drug
Proprietary NameEmmi-dent Whitening
Generic NameSodium Fluoride
Dosage FormPaste, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2019-07-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameEMAG AG
Substance NameSODIUM FLUORIDE
Active Ingredient Strength320 mg/75mL
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 63956-003-03

1 TUBE in 1 CARTON (63956-003-03) > 75 mL in 1 TUBE
Marketing Start Date2019-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63956-003-03 [63956000303]

Emmi-dent Whitening PASTE, DENTIFRICE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-30

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE320 mg/75mL

OpenFDA Data

SPL SET ID:dbc0cfe0-24ef-4ee2-b975-4044624a592f
Manufacturer
UNII

NDC Crossover Matching brand name "Emmi-dent Whitening" or generic name "Sodium Fluoride"

NDCBrand NameGeneric Name
63956-003Emmi-dent WhiteningEmmi-dent Whitening
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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