NDC 42368-005

Synedent FLX

Sodium Fluoride

Synedent FLX is a Oral Mouthwash in the Human Otc Drug category. It is labeled and distributed by Synedgen Inc.. The primary component is Sodium Fluoride.

Product ID42368-005_a0201a4f-b41c-2c1d-e053-2995a90a9d62
NDC42368-005
Product TypeHuman Otc Drug
Proprietary NameSynedent FLX
Generic NameSodium Fluoride
Dosage FormMouthwash
Route of AdministrationORAL
Marketing Start Date2019-09-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameSynedgen Inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 g/100mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 42368-005-00

59.1 mL in 1 BOTTLE, PLASTIC (42368-005-00)
Marketing Start Date2019-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42368-005-01 [42368000501]

Synedent FLX MOUTHWASH
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-01

NDC 42368-005-00 [42368000500]

Synedent FLX MOUTHWASH
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-30

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.02 g/100mL

OpenFDA Data

SPL SET ID:a0159047-5f4b-6190-e053-2a95a90a6d0e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 240698

    • NDC Crossover Matching brand name "Synedent FLX" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    42368-005Synedent FLXSynedent FLX
    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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