NDC 0126-0016

PreviDent 5000 Dry Mouth

Sodium Fluoride

PreviDent 5000 Dry Mouth is a Dental Gel, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Colgate Oral Pharmaceuticals Inc.. The primary component is Sodium Fluoride.

Product ID0126-0016_50488c66-4136-4137-842c-444cb65535ae
NDC0126-0016
Product TypeHuman Prescription Drug
Proprietary NamePreviDent 5000 Dry Mouth
Generic NameSodium Fluoride
Dosage FormGel, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2009-07-06
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameColgate Oral Pharmaceuticals Inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength6 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0126-0016-61

100 mL in 1 BOTTLE (0126-0016-61)
Marketing Start Date2009-07-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0126-0016-61 [00126001661]

PreviDent 5000 Dry Mouth GEL, DENTIFRICE
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-07-06

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE6.1 mg/mL

OpenFDA Data

SPL SET ID:d93ee76f-454b-40bf-9357-39a2ae3b6ccb
Manufacturer
UNII
UPC Code
  • 0301260016610