Nonprescription Drugs: Labelling Standards - Drug Product

A Summary of NHP/Drug Classification of TPD Category IV/Labelling Standard Ingredients

With the introduction of the Natural Health Products Directorate (NHPD) in 2004, several products previously regulated as drugs are now classified as natural health products. To facilitate the regulatory review process, a classification list has been developed to identify which of the TPD Category IV Monograph and Labelling Standard ingredients are considered to be either natural health products or drug products. Please note that if a product contains both a drug and a natural health product as active ingredients, then the overall product is deemed a drug and the Food & Drug Regulations apply.

Introduction to the TPD/NHPD Category IV Monographs and Labelling Standards

With the introduction of the Natural Health Products Directorate (NHPD) in 2004, several products previously regulated as drugs are now classified as natural health products. Please consult the Summary of NHP/Drug Classification of TPD Category IV/Labelling Standard Ingredients for a classification list which identifies which ingredients are considered to be either natural health products or drug products.

For those product claims which had been previously captured by a TPD Category IV Monograph or Labelling Standard but which contain active ingredients classified solely as natural health products, a link will take you to the revised NHPD monograph located on the Natural Health Products Directorate website.

For those product claims which had previously been captured by a TPD Category IV Monograph or Labelling Standard but which contain active ingredients classified as either drugs or natural health products, TPD and NHPD have undertaken to jointly revise the affected monograph in consultation with external stakeholders. The harmonized monographs will facilitate the regulatory review process and establish consistent guidelines for labelling requirements. A link will take you to the revised TPD/NHPD monograph located on the Natural Health Products Directorate website.

	Analgesics Labelling Standard Date: 1994-12-02
	Anorectal Drug Products Date: 1994-09-01
	Antacids Date: 1994-07-24
	Anthelmintics Date: 1996-05-17
	Antiflatulents Date: 1996-07-19
	Antifungal (Naftifine & Imidazole) Date: 1993-10-22
	Antifungals (topical) Date: 1995-01-30
	Bismuth Subsalicylate Date: 1996-05-17
	Caffeine Labelling Standard Date: 1992-09-22
	Chamomile Date: 1996-05-17
	Corn and Callous Removers Date: 2006-04-06
	Counterirritants Date: 1994-09-01
	Cyproheptadine Date: 1992-08-14
	Dental and Oral Care Products for Professional Use Date: 1997-03-19
	Dimenhydrinate Date: 1994-12-01
	Echinacea Root Date: 1997-06-01
	Ephedra Date: 1994-07-17
	Ephedrine/Pseudoephedrine Date: 1994-07-17
	Ethylene Oxide Gaseous Sterilants Date: 1995-09-05
	Famotidine Date: 1997-08-20
	Feverfew leaf Date: 1997-08-06
	Fluoride-Containing Treatment Gels and Rinses for Consumer Use Date: 2003-01-15
	Homeopathic Preparations Date: 1997-05-07
	Hydrocortisone Date: 1991-04-11
	Intestinal Flora Modifiers Date: 1995-06-05
	Intravaginal (Miconazole & Clotrimazole) Date: 1994-12-01
	Laxatives: Bulk Forming Date: 1994-09-01
	Laxatives: Carbon Dioxide Releasing Date: 1994-09-01
	Laxatives: General Date: 1994-09-01
	Laxatives: Hyperosmotic Date:1994-09-01
	Laxatives: Kit Bowel Cleansing System Date: 1994-09-01
	Laxatives: Lactulose Date: 1994-09-01
	Laxatives: Lubricant Date: 1994-09-01
	Laxatives: Saline Date: 1994-09-01
	Laxatives: Stimulant Date: 1997-10-03
	Laxatives: Stool Softener Date: 1994-09-01
	Lindane Lotion - Scabicide Date: 1989-12-12
	Lindane Shampoo - Pediculicide Date: 1989-12-12
	Mineral Supplements Date: 1996-12-06
	Nicotine Gum Date: 1997-05-17
	Nicotine Patches Date: 1997-11-12
	Non-Classical Antihistamines Date: 1998-04-01
	Oral Potassium Supplements Date: 1994-12-02
	Peppermint Date: 1996-05-17
	Peroxide Oral Care Products Date: 1995-09-29
	Poison Treatment Date: 1994-09-01
	Quaternary Ammonium Compounds for Use Against HIV Date: 1995-10-10
	Sleep Aids Date: 1993-07-12
	Topical Anaestheic/Analgesic/Antipruritic Date: 1994-09-01
	Topical Antibiotics Date: 1992-11-19
	Triethanolamine Salicylate (Trolamine) Date: 1995-09-13
	Ubiquinone Date: 1994-09-01
	Valerian Date: 1996-05-17
	Vitamin Supplements Date: 1995-01-24
	Wart Removers Date: 2006-04-06