Sodium Fluoride

What Is It?

Sodium Fluoride occurs as a white crystalline solid. Sodium Fluoride is used in the formulation of dentifrices, mouthwashes and breath fresheners.

Why Is It Used?

Sodium Fluoride aids in the prevention of dental cavities as an anticaries agent. It also polishes the teeth, reduces oral odor, and otherwise cleanses and deodorizes the teeth and mouth.

Scientific Facts

Sodium Fluoride is also known as sodium monofluoride. Sodium Fluoride is found in the form of cubic or tetragonal crystals.

Safety Information

The Food and Drug Administration (FDA) permits Sodium Flouride to be used as an indirect food additive. Sodium Fluoride is also permitted for use as an ingredient in Over-the-Counter (OTC) anticaries drug products. Cosmetic Ingredient Review (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.

The relationship between the consumption of fluoridated drinking-water and morbidity or mortality due to cancer has been examined in a large number of epidemiological studies, performed in many countries. There is no consistent evidence of an association between the consumption of controlled fluoridated drinking-water and increased morbidity or mortality due to cancer. Epidemiological studies show no evidence of an association between the consumption of fluoridated drinking-water by mothers and increased risk of spontaneous abortion or birth defects.

Link to FDA Code of Federal Regulations for Sodium Fluoride

Sodium Fluoride may be used in oral hygiene products marketed in the European Union at a maximum concentration of 0.15% calculated as F. When mixed with other fluorine compounds, total F concentration must not exceed 0.15% (see Annex III). When Sodium Fluoride is used in products they must be labeled “contains sodium fluoride”.


Sodium Fluoride, and other fluoride containing ingredients are not permitted in dentifrices, mouthwashes or breath drops marketed in Canada.

More Scientific Information

Sodium Fluoride is an inorganic salt, the sodium salt of hydrofluoric acid. Fluorides are released into the environment naturally through the weathering and dissolution of minerals, in emissions from volcanoes and in marine aerosols. Fluorides are also released into the environment via coal combustion and process waters and waste from various industrial processes, including steel manufacture, primary aluminum, copper and nickel production, phosphate ore processing, phosphate fertilizer production and use, glass, brick and ceramic manufacturing, and glue and adhesive production. The use of fluoride-containing pesticides as well as the controlled fluoridation of drinking-water supplies also contribute to the release of fluoride from man-made sources.


Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration

Find out more about the regulation of Food Additives by the Food and Drug Administration