Non-prescription Drugs: Labelling Standards - Drug Product
A non-prescription drug (NPD) labelling standard outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof. Labelling standards are developed for drugs that have a well characterized safety and efficacy profile under specific conditions of use. A sponsor may reference a labelling standard 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 labelling standard, or when a labelling standard does not exist, the sponsor should apply for a DIN through a different submission class.
For questions related to labelling standards or to request a labelling standard that is unavailable online, please e-mail: nnhpd-dpsnso@hc-sc.gc.ca
Labelling Standards:
- Acetaminophen Labelling Standard [2016-09-15]
- Acetylsalicylic Acid Labelling Standard [2013-10-17]
- Adult Cough, Cold and Flu [2025-04-01]
- Anorectal Drug Products [1994-09-01]
- Antacids [1994-07-24]
- Anthelmintics [1996-05-17]
- Antiflatulents [1996-07-19]
- Antifungals (topical) [1995-01-30]
- Bismuth Subsalicylate [1996-05-17]
- Oral Paediatric Cough and Cold [2009-02-06]
- Cyproheptadine [1992-08-14]
- Dimenhydrinate [1994-12-01]
- Laxatives: Bulk Forming [2012-07-09]
- Laxatives: General [1994-09-01]
- Laxatives: Lactulose [1994-09-01] – please contact NNHPD
- Laxatives: Lubricant [1994-09-01]
- Laxatives: Stimulant [1997-10-03]
- Laxatives: Stool Softener [2015-07-28]
- Sleep Aids [1993-07-12]
- Topical Anaestheic/Analgesic/Antipruritic [2015-07-29]
- Topical Antibiotics [1992-11-19]
- Topical Nasal Decongestants [2014-05-30]
- Triethanolamine Salicylate (Trolamine) [1995-09-13]
For more information on labelling requirements: