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Sodium fluoride (toothpaste)

Sodium fluoride (toothpaste) suppliers and sourcing guide

Sodium fluoride is a white, water-soluble inorganic salt made by neutralizing hydrofluoric acid, or fluorosilicic acid from phosphate fertilizer production, with sodium hydroxide or sodium carbonate, then crystallizing and drying. Toothpaste and mouth rinse makers buy pharmacopeial-grade powder and dose it to a fluoride ion target. In fluoride toothpaste it is the declared OTC drug active, so the grade, assay and abrasive compatibility all matter.

Also known as
Sodium fluoride · NaF · CAS 7681-49-4
Facts checked
November 2026

Forms and grades of sodium fluoride (toothpaste)

Suppliers sell different products under the same name. Specify the one you need.

  • Pharmacopeial powder

    USP or Ph. Eur. sodium fluoride, the grade used as an OTC drug active in dentifrices and rinses.

  • Granular or fine powder

    Particle-size grades chosen for dissolving speed and dust control during batching.

  • Food or technical grade

    Grades for water fluoridation or industrial use; not interchangeable with pharmacopeial material for toothpaste.

What to check on the COA

Compare each result with your own specification when the lot arrives.

Assay
Sodium fluoride content by ion-selective electrode or titration against the compendial range.
Fluorosilicate and other anions
Limit tests for fluorosilicate, chloride and sulfate impurities.
Loss on drying
Moisture content, which affects how much fluoride each kilogram delivers.
Acidity or alkalinity
Compendial test of free acid or base.
Heavy metals
Lead and other metals by ICP-MS.

Storage, lots and expiry

Storage and shelf life

Store sodium fluoride in tightly closed, labeled plastic containers in a dry place, segregated from food ingredients and acids; it is toxic if swallowed in quantity. Control dust during weighing. Shelf life and retest are set by the supplier's specification.

Lots and expiry dates

Record the assay for each lot and adjust batch weights if needed to hit the fluoride target. Keep lot traceability through to finished goods, since available fluoride is tested on the finished toothpaste.

Regulatory status

Facts from regulators and standards bodies, each linked to its source.

  • 21 CFR 355.10 lists sodium fluoride at 0.188 to 0.254 percent, with an available fluoride ion concentration of at least 650 ppm, as an OTC anticaries active in gel or paste dentifrices containing 850 to 1,150 ppm theoretical total fluorine.

    Source: ecfr.gov (opens in a new tab)
  • Health Canada's Oral Health Products Monograph lists sodium fluoride at 0.188 to 0.254% w/w in dentifrices, with available fluoride ion of at least 650 mg/kg.

    Source: webprod.hc-sc.gc.ca (opens in a new tab)
  • Health Canada's Cosmetic Ingredient Hotlist does not permit sodium fluoride and other fluoride-containing substances in oral cosmetic products.

    Source: canada.ca (opens in a new tab)

This is general information, not regulatory advice. Status differs by country and by how the ingredient is used, so check the rules for your product and market.

Sodium fluoride (toothpaste) suppliers

Manufacturers and distributors whose own websites say they sell it.

We are checking sodium fluoride (toothpaste) suppliers now

Every listing is checked against the supplier’s own website before it goes live, so this list fills in over the coming weeks. The specs and COA checklist above are ready today.

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Frequently asked questions

What forms of sodium fluoride (toothpaste) can brands buy?

Common forms include pharmacopeial powder, granular or fine powder and food or technical grade. Ask each supplier for the specification sheet of the exact grade they quote.

What should the COA for sodium fluoride (toothpaste) include?

Expect assay, fluorosilicate and other anions, loss on drying, acidity or alkalinity and heavy metals, each with its method, specification and result for that lot.

How should sodium fluoride (toothpaste) be stored?

Store sodium fluoride in tightly closed, labeled plastic containers in a dry place, segregated from food ingredients and acids; it is toxic if swallowed in quantity. Control dust during weighing. Shelf life and retest are set by the supplier's specification.

What is the regulatory status of sodium fluoride (toothpaste)?

21 CFR 355.10 lists sodium fluoride at 0.188 to 0.254 percent, with an available fluoride ion concentration of at least 650 ppm, as an OTC anticaries active in gel or paste dentifrices containing 850 to 1,150 ppm theoretical total fluorine. Health Canada's Oral Health Products Monograph lists sodium fluoride at 0.188 to 0.254% w/w in dentifrices, with available fluoride ion of at least 650 mg/kg. Health Canada's Cosmetic Ingredient Hotlist does not permit sodium fluoride and other fluoride-containing substances in oral cosmetic products.

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