NDC 53045-235

Ionite APF Neutral

Sodium Fluoride

Ionite APF Neutral is a Dental; Oral; Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Dharma Research, Inc.. The primary component is Sodium Fluoride.

Product ID53045-235_062028c9-c82d-49d7-b0ef-27cb99d69e7f
NDC53045-235
Product TypeHuman Prescription Drug
Proprietary NameIonite APF Neutral
Generic NameSodium Fluoride
Dosage FormGel
Route of AdministrationDENTAL; ORAL; TOPICAL
Marketing Start Date2013-01-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameDharma Research, inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength4 g/490g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53045-235-17

490 g in 1 BOTTLE (53045-235-17)
Marketing Start Date2013-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53045-235-17 [53045023517]

Ionite APF Neutral GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE4.41 g/490g

OpenFDA Data

SPL SET ID:ad7a660b-274c-417e-bdf3-1d5addf06ad1
Manufacturer
UNII

NDC Crossover Matching brand name "Ionite APF Neutral" or generic name "Sodium Fluoride"

NDCBrand NameGeneric Name
53045-235Ionite APF NeutralIonite APF Neutral
53045-237Ionite APF NeutralIonite APF Neutral
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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