Drugplain

PRO-SYS .11 g/100g

Sodium Fluoride and Potassium Nitrate · PASTE, DENTIFRICE · Benco Dental

No Recall HistoryCurrently in Shortage
Plain English

PRO-SYS is a prescription paste, dentifrice containing sodium fluoride and potassium nitrate at .11 g/100g, taken dental. Manufactured by Benco Dental.

Key Facts

Brand Name
PRO-SYS
Generic Name
Sodium Fluoride and Potassium Nitrate
NDC Code (Product)
66975-700
Manufacturer
Benco Dental
Strength
.11 g/100g
Dosage Form
PASTE, DENTIFRICE
Route
DENTAL, ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M021
Marketing Start
12/01/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia170 reports
fatigue159 reports
nausea158 reports
vomiting156 reports
pain154 reports
weight increased154 reports
nasopharyngitis152 reports
type 2 diabetes mellitus145 reports
peripheral swelling144 reports
urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Indications PRO-SYS Professional is a self-applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity.

Dosage & Administration

Directions: Use as Directed This prescription dentifrice is recommended for adults and pediatric patients six years and older. • Apply a thin ribbon of PRO-SYS Professional along the length of the toothbrush no more than "pea size" total dose. Brush for two minutes. • After brushing: ADULTS-Expectorate; do not eat or drink for 30 minutes. CHILDREN SIX YEARS OF AGE OR OLDER-Expectorate and rinse mouth with water. • Use at bedtime in place of your regular toothpaste or as directed by your dental professional.

Warnings

Warnings Do not swallow For topical use only As with all medications, keep out of reach of children

Frequently Asked Questions

What is PRO-SYS used for?

PRO-SYS contains Sodium Fluoride and Potassium Nitrate. It is a paste, dentifrice taken dental. Consult your doctor for specific uses.

Is PRO-SYS a controlled substance?

PRO-SYS is not classified as a controlled substance by the DEA.

What is the generic name for PRO-SYS?

The generic name for PRO-SYS is Sodium Fluoride and Potassium Nitrate. There are 9 other brand versions of Sodium Fluoride and Potassium Nitrate.

What is the NDC code for PRO-SYS .11 g/100g?

The NDC (National Drug Code) for PRO-SYS .11 g/100g is 66975-700, listed by Benco Dental.