NDC 64893-800

SmileGuard Just 4 Me

Sodium Fluoride

SmileGuard Just 4 Me is a Dental Paste in the Human Otc Drug category. It is labeled and distributed by Dr. Fresh, Inc.. The primary component is Sodium Fluoride.

Product ID64893-800_71bf5e23-492c-bd5b-e053-2a95a90ab67f
NDC64893-800
Product TypeHuman Otc Drug
Proprietary NameSmileGuard Just 4 Me
Generic NameSodium Fluoride
Dosage FormPaste
Route of AdministrationDENTAL
Marketing Start Date2011-08-17
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameDr. Fresh, Inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 g/100g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 64893-800-01

1 TUBE in 1 POUCH (64893-800-01) > 24 g in 1 TUBE
Marketing Start Date2011-08-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64893-800-01 [64893080001]

SmileGuard Just 4 Me PASTE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.15 g/100g

OpenFDA Data

SPL SET ID:6c664c11-5c2b-4a95-8494-c9e2dbc3e64c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 891775
    • UPC Code
  • 0672935303145

    • NDC Crossover Matching brand name "SmileGuard Just 4 Me" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    64893-800SmileGuard Just 4 MeSmileGuard Just 4 Me
    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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