NDC 66975-053

Iris 60 Second APF

Sodium Fluoride

Iris 60 Second APF is a Dental Gel in the Human Prescription Drug category. It is labeled and distributed by Benco Dental. The primary component is Sodium Fluoride.

Product ID66975-053_c01e22ae-662c-468d-b11d-a095770427cd
NDC66975-053
Product TypeHuman Prescription Drug
Proprietary NameIris 60 Second APF
Generic NameSodium Fluoride
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2012-12-14
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameBenco Dental
Substance NameSODIUM FLUORIDE
Active Ingredient Strength6 g/454g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 66975-053-15

454 g in 1 BOTTLE, PLASTIC (66975-053-15)
Marketing Start Date2016-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66975-053-15 [66975005315]

Iris 60 Second APF GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE5.6 g/454g

OpenFDA Data

SPL SET ID:8f5d420b-3348-4002-9a09-b05e8cbb35c9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245593

    • NDC Crossover Matching brand name "Iris 60 Second APF" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    66975-054Iris 60 Second APFIris 60 Second APF
    66975-052Iris 60 Second APFIris 60 Second APF
    66975-050Iris 60 Second APFIris 60 Second APF
    66975-051Iris 60 Second APFIris 60 Second APF
    66975-053Iris 60 Second APFIris 60 Second APF
    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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