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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.



June 3, 2019

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s) Preparation
Hydrastis canadensis
  • Goldenseal
  • Orangeroot
  • Yellow-puccoon
  • Yellow root
Hydrastis canadensis Root and rhizome Dried

References: Proper name: USDA 2019; Common names: McGuffin et al. 2000, Wiersema and Le?n 1999; Source material: Blumenthal 2003, Hoffmann 2003, Bradley 1992.

Route of Administration


Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Dosage forms must be suited for buccal administration which allow for direct contact between the affected tissue and the medicinal ingredient (i.e. liquid preparations, gargles and mouthwashes).

Use(s) or Purpose(s)

Traditionally used in Herbal Medicine to help relieve mucous membrane inflammations of the mouth (Bradley 1992; Ellingwood 1983; Grieve 1971).

Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".



Adults 18 years and older


Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

0.6 - 3 grams of dried root and rhizome, per day (Bradley 1992).

Direction(s) for use

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)


Do not use this product if you are pregnant or breastfeeding (Barnes and al. 2007; Mills and Bone 2005; Boon and Smith 2004; Hoffmann 2003; Brinker 2001; Bradley 1992).

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

No statement required.


References Cited

References Reviewed