NDC 11527-745

Sodium Fluoride 5000 ppm Enamel Protect

Sodium Fluoride1.1%, Potassium Nitrate 5%

Sodium Fluoride 5000 ppm Enamel Protect is a Dental Gel, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Sheffield Pharmaceuticals Llc. The primary component is Potassium Nitrate; Sodium Fluoride.

Product ID11527-745_3fa71e96-0c84-4ce6-8aa8-6689b876c480
NDC11527-745
Product TypeHuman Prescription Drug
Proprietary NameSodium Fluoride 5000 ppm Enamel Protect
Generic NameSodium Fluoride1.1%, Potassium Nitrate 5%
Dosage FormGel, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2021-01-08
Marketing CategoryUNAPPROVED DRUG OTHER /
Labeler NameSheffield Pharmaceuticals LLC
Substance NamePOTASSIUM NITRATE; SODIUM FLUORIDE
Active Ingredient Strength58 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 11527-745-34

1 TUBE in 1 CARTON (11527-745-34) > 100 mL in 1 TUBE
Marketing Start Date2021-01-08
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Sodium Fluoride 5000 ppm Enamel Protect" or generic name "Sodium Fluoride1.1%, Potassium Nitrate 5%"

NDCBrand NameGeneric Name
11527-745Sodium Fluoride 5000 ppm Enamel ProtectSodium Fluoride1.1%, Potassium Nitrate 5%
11527-704Sodium Fluoride 5000 ppm SensitiveSodium Fluoride1.1%, Potassium Nitrate 5%

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