NDC 59883-168

Pro-Den Rx

Sodium Fluoride

Pro-Den Rx is a Oral Gel in the Human Otc Drug category. It is labeled and distributed by Zila Therapeutics, Inc.. The primary component is Sodium Fluoride.

Product ID59883-168_7f549575-e740-4963-b105-ef4b4f850a2d
NDC59883-168
Product TypeHuman Otc Drug
Proprietary NamePro-Den Rx
Generic NameSodium Fluoride
Dosage FormGel
Route of AdministrationORAL
Marketing Start Date2008-11-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameZila Therapeutics, Inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 mL/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 59883-168-16

473 mL in 1 TUBE (59883-168-16)
Marketing Start Date2008-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59883-168-16 [59883016816]

Pro-Den Rx GEL
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-11-21
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.044 mL/mL

OpenFDA Data

SPL SET ID:7a1a6bfd-728d-4123-8381-dd405e84e753
Manufacturer
UNII

NDC Crossover Matching brand name "Pro-Den Rx" or generic name "Sodium Fluoride"

NDCBrand NameGeneric Name
59883-820Pro-Den RxPro-Den Rx
59883-824Pro-Den RxPro-Den Rx
59883-720Pro-Den RxPro-Den Rx
59883-821Pro-Den RxPro-Den Rx
59883-912Pro-Den RxPro-Den Rx
59883-168Pro-Den RxPro-Den Rx
59883-911Pro-Den RxPro-Den Rx
59883-920Pro-Den RxPro-Den Rx
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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