NDC 59883-031

FLUORIDEX

Sodium Fluoride

FLUORIDEX is a Dental Paste, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Dent-mat Holdings, Llc.. The primary component is Potassium Nitrate; Sodium Fluoride.

Product ID59883-031_740694d0-55c7-154c-e053-2991aa0a3a56
NDC59883-031
Product TypeHuman Prescription Drug
Proprietary NameFLUORIDEX
Generic NameSodium Fluoride
Dosage FormPaste, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2016-12-21
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameDENT-MAT HOLDINGS, LLC.
Substance NamePOTASSIUM NITRATE; SODIUM FLUORIDE
Active Ingredient Strength50 mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59883-031-04

1 TUBE in 1 BOX (59883-031-04) > 112 g in 1 TUBE
Marketing Start Date2016-12-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59883-031-04 [59883003104]

FLUORIDEX PASTE, DENTIFRICE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-12-21

NDC 59883-031-05 [59883003105]

FLUORIDEX PASTE, DENTIFRICE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-22

Drug Details

Active Ingredients

IngredientStrength
POTASSIUM NITRATE50 mg/g

OpenFDA Data

SPL SET ID:601774d5-f4de-01bc-e053-2991aa0a7f4f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 637365
  • 847014