ApprovalTrail

Natural health product · NPN 80128140

ONRAL

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 November 21, 2023; licence last revised January 14, 2026.
Natural Product Number (NPN)
80128140
Licence holder
Syka Pharma inc.
Dosage form
Mouthwash
Route
Oromucosal
Licensing route
Compendial
First licensed
November 21, 2023
Licence last revised
January 14, 2026

Medicinal ingredients

Per dosage unit, as licensed.

IngredientAmount
4-Aminobenzoic acid, ethyl ester5 %

What it is licensed for

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

  • For the temporary relief of occasional minor irritation or injury of the mouth. For the temporary relief of occasional minor oral irritation/oral pain/sore mouth. For the temporary relief of pain associated with canker sores/aphthous stomatitis. For the temporary relief of pain associated with cold sores/fever blisters/oral herpes.

Non-medicinal ingredients

Glycérol; Citric acid; Polysorbate 80; Potassium sorbate; Orange flavour; PEG-400; Sorbitol; Purified water; Flavour; Xanthan Gum