OTC Drug Compliance | Drug Identification Number DIN in North America

Get complete OTC Drug Compliance Solutions, such as DIN registration (Canada), PLL Compliance, NDC Registration (USA), Drug Label Compliance, Drug Facility Registration and Renewal, and more. 

Drug categories include over-the-counter (OTC), Prescription drugs, Radiopharmaceuticals, Biologics, and Gene Therapies. OTC Drugs, which is also called non-prescription drugs, are health products that are sold in the Canadian and USA market and can be bought without a medical prescription.  These drugs are safe and effective for use. 

Health Canada regulates OTC drugs to ensure they are safe to use and reduce health risks to Canadians. In USA, FDA conducts a regulatory review of OTC drugs based on active pharmaceutical ingredients and labeling not by assessing individual drug formulations. There are almost 300,000 OTC drug products in the US market.

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Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with Health Canada

Why the Need for OTC Drug Compliance Solutions

OTC Drugs to be sold in Canada require a Drug Identification Number (DIN). This number on a product label indicates the drug has met all requirements for quality, safety, and effectiveness. Canadian firms that are engaged in manufacturing, packaging, labeling, and importing non-prescription drugs must be licensed for these activities. Similarly, any company intending to produce OTCs in USA is required to ensure that their product meets the standards for safety and efficacy. They should ensure whether they are compliant with GMPs and meet the labeling requirements as set out in 21 CFR part 201.66. The process of meeting the requirements of Health Canada and FDA can be complex in many cases.  Let Quality Smart Solutions help you prepare your OTC application accurately and efficiently.

otc drug identification din number
Monograph Categories

There are several monograph categories for OTC Drugs in Canada, such as Labeling Standard, TPD Category IV, and NSAIDs. Meeting their requirements is difficult.

Regulatory Pathways

To market OTC drugs in USA, you need to go through two Regulatory Pathways, OTC Drug Monograph Application Process and the OTC New Drug Application (NDA) process.

Good Manufacturing Practices

Any firm (domestic or foreign) manufacturing, distributing, or importing OTD drugs require to show evidence that they are following GMP.

Establishment License

To manufacture, sell, or import non-prescription drugs, businesses must obtain an establishment license.

Product Types we have Licenced

Sports Nutrition
Sunscreens
Hand Sanitizers
Multi Vitamins
Super Green Health Products
Energy Boost Products
Gummies

Turnkey Solutions for OTC Drug Compliance in Canada

Our Canadian OTC Regulatory Experts are backed with extensive knowledge and years of experience. We offer OTC compliance consulting services for all types of companies to lessen regulatory risk and assure a speedy way for the launch of your OTC drug. 

OTC Drug Compliance Solutions in USA

At Quality Smart Solutions, we have the capability to offer assistance in all phases of the drug facility registration, drug development cycle, such as business planning, product development, meeting USA drug label compliance, and more.

Frequently Asked Questions

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.
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.
A Medical Device Establishment Licence (MDEL) is a licence issued to manufacturers of Class I medical devices as well as importers or distributors of all device classes. The MDEL permits them to import or distribute a medical device in Canada. An MDEL provides Health Canada assurance that medical devices sold or imported into Canada meet the safety requirements set out in the Medical Devices Regulations, and that procedures are in place to protect the public should a problem with a device be identified. The MDEL listing contains information about the licensed establishment including their company ID, licence number, company name, address, authorized activities and associated class of device(s).

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