Non-prescription Drugs: Category IV Monographs

A non-prescription drug (NPD) Category IV Monograph outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof. Category IV Monographs are developed for drugs that have a well characterized safety and efficacy profile under specific conditions of use. A sponsor may reference a Category IV Monograph in a drug submission when the product and its labelling are consistent with the information set out in the document.

If an NPD does not meet the parameters specified in a Category IV Monograph or when a Category IV Monograph does not exist,, the sponsor should apply for a DIN through a different submission class.

Please note that if a therapeutic product contains an active ingredient that would be regulated under the Food and Drug Regulations and an active ingredient that would be regulated under the Natural Health Product Regulations, then the overall product is deemed a drug and the Food & Drug Regulations apply.

The Category IV Monographs include:

• Acne Therapy (2025)
• Anti-Dandruff Products (2018)
• Antiseptic Skin Cleansers (2024)
• Athlete's Foot Treatment (2024)
• Diaper Rash Products (2024)
• First Aid Antiseptics (2024)
• Male Genital Desensitizers (2025)
• Medicated Skin Care Products (2024)
• Oral Health Products (2024)
• Primary Sunscreen (2026)
• Secondary Sunscreen (2026)
• Throat Lozenges (2024)