NDC 70766-004

Amerfresh Tooth

Sodium Fluoride

Amerfresh Tooth is a Dental Powder in the Human Otc Drug category. It is labeled and distributed by Yangzhou Sion Commodity Co.,ltd. The primary component is Sodium Fluoride.

Product ID70766-004_80e3b705-65c8-0cc5-e053-2991aa0a6d97
NDC70766-004
Product TypeHuman Otc Drug
Proprietary NameAmerfresh Tooth
Generic NameSodium Fluoride
Dosage FormPowder
Route of AdministrationDENTAL
Marketing Start Date2018-04-20
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameYangzhou SION Commodity Co.,Ltd
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 g/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70766-004-01

40 PACKAGE in 1 CARTON (70766-004-01) > 454 g in 1 PACKAGE
Marketing Start Date2018-04-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70766-004-02 [70766000402]

Amerfresh Tooth POWDER
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-20

NDC 70766-004-01 [70766000401]

Amerfresh Tooth POWDER
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-20

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.1 g/100g

OpenFDA Data

SPL SET ID:ff4d62a9-2f0b-495f-aa52-9030193d7148
Manufacturer
UNII

NDC Crossover Matching brand name "Amerfresh Tooth" or generic name "Sodium Fluoride"

NDCBrand NameGeneric Name
70766-004Amerfresh ToothAmerfresh Tooth
70766-005AmerFresh ToothAmerFresh Tooth
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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