Is an NDC number required for a non-prescription drug label?

For a non-prescription drug label, an NDC (National Drug Code) number is not traditionally required. The NDC system is primarily utilized for prescription drugs and certain over-the-counter drugs that are marketed commercially. While many over-the-counter products do carry an NDC as a way to identify the product and facilitate tracking and reporting, it is not mandatory for all non-prescription formulations. This lack of a requirement allows non-prescription products to be marketed and sold without being assigned an NDC, as long as they comply with other labeling and safety regulations set forth by the FDA. Thus, choosing that an NDC number is not required for a non-prescription drug label aligns with current FDA standards and guidelines.