NDC 11527-704

Sodium Fluoride 5000 ppm Sensitive

Sodium Fluoride1.1%, Potassium Nitrate 5%

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

• Product ID: 11527-704_c850c90a-b9bc-44b7-b30c-3f297f3ae164
• NDC: 11527-704
• Product Type: Human Prescription Drug
• Proprietary Name: Sodium Fluoride 5000 ppm Sensitive
• Generic Name: Sodium Fluoride1.1%, Potassium Nitrate 5%
• Dosage Form: Gel, Dentifrice
• Route of Administration: DENTAL
• Marketing Start Date: 2020-03-26
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Sheffield Pharmaceuticals LLC
• Substance Name: SODIUM FLUORIDE; POTASSIUM NITRATE
• Active Ingredient Strength: 6 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 11527-704-42

1 TUBE in 1 CARTON (11527-704-42) > 100 mL in 1 TUBE

• Marketing Start Date: 2020-03-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 11527-704-42 [11527070442]

Sodium Fluoride 5000 ppm Sensitive GEL, DENTIFRICE

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-26

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	5.8 mg/mL

OpenFDA Data

• SPL SET ID: 02f4cf0b-188c-4522-b759-ffe4a9d150e8
• Manufacturer:
  • Sheffield Pharmaceuticals LLC
• UNII:
  • RU45X2JN0Z
  • 8ZYQ1474W7

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

NDC	Brand Name	Generic Name
11527-704	Sodium Fluoride 5000 ppm Sensitive	Sodium Fluoride1.1%, Potassium Nitrate 5%
11527-745	Sodium Fluoride 5000 ppm Enamel Protect	Sodium Fluoride1.1%, Potassium Nitrate 5%