OTC stands for “Over-The-Counter”. Non-prescription drugs, also called over-the-counter drugs, are health products that can be bought without a doctor’s prescription. Canada regulates these types of products to ensure they are safe for use and reduce health risks to the public.

How do you sell an OTC drug in Canada?

Non-prescription OTC drugs require a valid Drug Identification Number (DIN) to be sold in Canada.

A Drug Identification Number (DIN) is a computer-generated eight digit number assigned by Health Canada to a drug product prior to being marketed in Canada. It uniquely identifies all drug products sold in a dosage form in Canada and is located on the label of prescription and over-the-counter drug products that have been evaluated and authorized for sale in Canada. A DIN lets the user know that the product has undergone and passed a review of its formulation, labeling and instructions for use. A drug product sold in Canada without a DIN is not in compliance with Canadian law.

What is the Drugs Facts Table and how does it apply to Non-prescription drugs?

Through Health Canada’s Plain Language Labelling Initiative, there are new requirements for health product labelling and packaging, including a requirement for a Drug Facts Table (Facts Table) on the outer label of non-prescription drugs. The standardized format of the Drug Facts Table will help consumers find important product information quickly and easily.

How to Apply for a DIN Number?

To apply for a DIN number, you must be an authorized manufacturer holding a Drug Establishment License (DEL). You or your delegated representative must submit a completed Drug Identification Number Application Form to Health Canada directly. After review and approval, Health Canada will assign a DIN-NNN-NNNN format, providing you with the authorization to manufacture and sell the drug.

What are the benefits of Having a DIN Number?

Having a unique Drug Identification Number (DIN) assigned to your product allows it to be tracked and its safety monitored by Health Canada. With this unique number, you can register your product in the Canadian marketplace, which allows retailers to purchase it without any concern or question of authenticity or safety. In addition, having a DIN also helps protect your brand name since you will be the only manufacturer associated with the specific DIN number.

What documents are required for obtaining a DIN number?

When applying for a DIN number, you will need to provide several documents. These documents include a completed application form, the product labeling text, evidence of Good Manufacturing Practice (GMP) approval, product safety and efficacy data reports, proof of payment of fees, and any supporting documents requested by Health Canada. All documents must be complete and accurate for your application to be approved.

What processing time and fees are Involved in obtaining a DIN Number?

Processing time for a DIN number can vary depending on the complexity of your application. Generally speaking, it may take 4-6 weeks to receive a response from Health Canada. There are also fees associated with obtaining a DIN number, including an initial set-up fee and an annual renewal fee for manufacturers. It is important to research the fees involved before submitting your application as changes may occur over time.

Why are DIN numbers significant?

Drug identification numbers, or DINs, are unique numbers that regulatory bodies assign to identify medications. DINs track and manage drug information throughout the supply chain, from manufacturing to distribution to patient use. This standardized system ensures that every medication has a unique identifier that can be easily tracked and traced, making it easier to identify and manage drug interactions, side effects, and adverse reactions. DINs are essential for healthcare professionals because they help prevent medication errors and ensure patients receive the correct treatment. With the increasing complexity of drug interactions and the rise of online pharmacies, DINs have become even more critical in recent years. By providing a standardized method for identifying medications, DINs help ensure that patients receive the proper medication in the correct dosage, reducing the risk of adverse reactions and improving patient outcomes.

How do DINs streamline the prescription process?

One of the most significant benefits of DINs is how they streamline the prescription process. With a unique identifier for each medication, healthcare professionals can quickly and easily access information about a particular drug, including dosage, side effects, and interactions with other medicines. This information can be accessed through various channels, including electronic health records, drug databases, and prescription drug monitoring programs. DINs also help speed up the prescription process by reducing the risk of errors and ensuring that prescriptions are filled accurately. With a unique identifier for each medication, pharmacists can quickly verify that they are dispensing the correct medication and dosage. This reduces the risk of medication errors and helps ensure that patients receive the proper medication at the right time.

How do DINs improve patient safety?

Patient safety is a top priority in healthcare, and DINs are crucial in ensuring patients receive safe and effective treatment. DINs help prevent medication errors and reduce the risk of adverse reactions by providing a standardized method for identifying medications. This is particularly important for patients taking multiple medications, as the risk of drug interactions and adverse events is higher in these cases. DINs also help improve patient safety by clearly and concisely communicating drug information to patients. With a unique identifier for each medication, patients can be confident that they receive the correct medication and dosage, reducing the risk of confusion and medication errors.

How DINs help prevent medication errors?

One of the most significant benefits of DINs is their ability to help prevent medication errors. With a unique identifier for each medication, healthcare professionals can quickly and easily access essential drug information, including dosage, side effects, and interactions with other medicines. This information can be used to identify potential issues and help prevent medication errors before they occur. DINs also help prevent medication errors by reducing the risk of confusion between medications. With a unique identifier for each drug, healthcare professionals can quickly and easily verify that they are prescribing the correct medication and dosage. This reduces the risk of confusion between medicines with similar names or packaging, which can lead to medication errors and adverse reactions.

What will be the role of DINs in the digital age?

DINs have been around for several decades, but their importance has grown in recent years with the rise of digital healthcare technologies. With the increasing use of electronic health records, drug databases, and other digital tools, DINs have become essential for managing drug information and ensuring patient safety. DINs are also becoming more widespread in the pharmaceutical industry, with many companies adopting the system to improve supply chain management and ensure product safety. This trend is expected to continue in the coming years, with DINs becoming even more critical as the healthcare industry continues to evolve and embrace new technologies.

What is the importance of accurate and up-to-date DINs?

The accuracy and completeness of DINs are essential for ensuring patient safety and effective healthcare management. As new drugs are developed and existing medications are updated, DINS must be updated and maintained to reflect these changes. Regulatory bodies, such as Health Canada and the FDA, ensure that DINs are accurate and up-to-date. These organizations assign DINs to new medications and update existing DINs as needed. They also work closely with healthcare professionals and pharmaceutical companies to ensure that DINs are used effectively and accurately throughout the drug supply chain.

OTC Drug Compliance DIN Number Canada - Quality Smart Solutions

Health Canada bulletin on NHP site license renewal

Are you meeting Health Canada’s site license renewal requirements?

Over the past few weeks, many natural health product (NHP) companies have been caught off guard by an increase in site license suspensions or renewal

July 11, 2025

Health Canada’s interim report on sodium targets for processed food

Health Canada issues interim report on sodium targets for processed food

Introduction Sodium reduction in processed foods is no longer optional. It is a critical step for industry players to safeguard consumer health and meet Health

July 9, 2025

FDA food labeling compliance program update 2025

FDA Updates Food Labeling Compliance Program

The FDA Food labeling compliance program has just been updated to help food manufacturers and importers meet U.S. labeling requirements more effectively. On June 20, 2025, the U.S. Food and Drug Administration (FDA) announced a revised Compliance Program Manual (CPM) for general food labeling.

June 26, 2025

Medical device compliance process – FDA 510k pre-submission vs PMA

FDA 510(k) pre-submissions vs PMA: What’s the difference?

When preparing to launch a medical device in the U.S., one of the first and most important decisions

June 23, 2025

Over-the-Counter Drug Compliance Solutions (OTC) | OTC Drugs

Why are our OTC Drug Compliance Solutions Important?

Products we have successfully licensed!

Turnkey Solutions for OTC Drug Compliance & Your DIN Number

Frequently Asked Questions - OTC Drugs & DIN Numbers

Are you meeting Health Canada’s site license renewal requirements?

Health Canada issues interim report on sodium targets for processed food

FDA Updates Food Labeling Compliance Program

FDA 510(k) pre-submissions vs PMA: What’s the difference?