Biotene Toothpaste

Yes: licensed in Canada

The product licence is active. Whether the product is actually on the market is a separate, voluntary notice; the official record shows it.

Licence status Active; licensed September 18, 2012; licence last revised October 17, 2025.

Natural Product Number (NPN): 80035511
Licence holder: Haleon Canada ULCMississauga, Ontario, Canada
Dosage form: Paste
Route: Dental
Licensing route: Compendial
First licensed: September 18, 2012
Licence last revised: October 17, 2025

Medicinal ingredients

Per dosage unit, as licensed.

Ingredient	Amount	Source and potency
Sodium fluoride	0.254 % (w/w)	Fluoride; 0.115 % (w/w) Theoretical total fluoride ion
Sodium fluoride	—	Fluoride; 0.188 % (w/w) Available fluoride ion

What it is licensed for

The licence’s own wording. Directions, doses, cautions and warnings are on the official record and the label.

Fluoride toothpaste. Prevents, fights or protects against cavities or caries; or reduces the incidence of cavities; or helps prevent tooth decay. Effective fluoride protection or effective decay preventive fluoride. Penetrates tooth enamel to help rebuild weak spots. Helps remineralize tooth enamel. Protects teeth from acid wear/erosion. Anti-cavity/Anti-caries. Reduces the incidence of cavities/caries. Helps delay/ slow the tooth decay process at the earliest stage before it can become a cavity

Non-medicinal ingredients

Hydrated Silica; Sodium Saccharin; Mint Flavour; Sucralose; Titanium dioxide; Xanthan Gum; PEG-8; Glycerin; Water; Sodium Hydroxide; Cocamidopropopyl betaine; d-Sorbitol

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “biotene”. A notice may cover another product or only some lots: read it to see what it covers.

Biotene Dry Mouth Toothpaste (2015-07-13)July 16, 2015 · Natural health products · Product safety · Type II