NDC 68400-115

Gelato Neutral pH

Sodium Fluoride

Gelato Neutral pH is a Dental Gel in the Human Prescription Drug category. It is labeled and distributed by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.. The primary component is Sodium Fluoride.

Product ID68400-115_d5f6699c-aeb6-1447-e053-2995a90a8b66
NDC68400-115
Product TypeHuman Prescription Drug
Proprietary NameGelato Neutral pH
Generic NameSodium Fluoride
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2013-03-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength4 g/454g
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68400-115-15

454 g in 1 BOTTLE, PLASTIC (68400-115-15)
Marketing Start Date2018-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68400-115-15 [68400011515]

Gelato Neutral pH GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE4.086 g/454g

OpenFDA Data

SPL SET ID:2dda92cc-2e50-4fa8-a214-714750943b00
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245593
  • 656838

    • NDC Crossover Matching brand name "Gelato Neutral pH" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    68400-136Gelato Neutral pHGelato Neutral pH
    68400-115Gelato Neutral pHGelato Neutral pH
    68400-114Gelato Neutral pHGelato Neutral pH
    68400-324Gelato Neutral pHGelato Neutral pH
    68400-138Gelato Neutral PHGelato Neutral PH
    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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