NDC 59883-016

FLUORIDEX

Sodium Fluoride

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

Product ID59883-016_82f8ac58-f95d-255b-e053-2a91aa0aceb7
NDC59883-016
Product TypeHuman Prescription Drug
Proprietary NameFLUORIDEX
Generic NameSodium Fluoride
Dosage FormPaste, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2016-12-30
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameDEN-MAT HOLDINGS, LLC.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength5 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59883-016-04

1 TUBE in 1 BOX (59883-016-04) > 112 g in 1 TUBE
Marketing Start Date2016-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59883-016-04 [59883001604]

FLUORIDEX PASTE, DENTIFRICE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-12-30

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE5 mg/g

OpenFDA Data

SPL SET ID:5fd60635-4b66-15e3-e053-2991aa0ab23a
Manufacturer
UNII