Is an NDC number required on over-the-counter (OTC) products?

An NDC number is not universally required on over-the-counter (OTC) products. While NDC (National Drug Code) numbers are used to identify drugs and are generally assigned to all medications, including OTC products, their use on retail packaging is not mandated for all OTC drugs. The requirement for an NDC number can depend on various factors including regulatory updates and specific product categories.

Generally, while most manufacturers assign NDC numbers to their OTC products for identification and tracking purposes, it is not a legal requirement to have the NDC on the packaging of all OTC medications available to consumers. Some products might be sold or packaged without an NDC number, especially if they fall into certain exemptions or categories. Thus, stating that an NDC number is not required accurately reflects the regulatory landscape for OTC products.