Successfully marketing over-the-counter (OTC) drug products in the United States requires compliance with strict FDA regulations. Two fundamental steps that companies must complete are FDA OTC Drug Registration and FDA NDC Registration. These registrations are essential to ensure the legal distribution, traceability, and safety of OTC drugs, making them indispensable for manufacturers, importers, and distributors.

FDA OTC Drug Registration is a mandatory process where companies involved in the manufacturing, repackaging, relabeling, or importing of OTC drug products register their facilities with the U.S. Food and Drug Administration (FDA). This registration is regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA).

The registration must be updated annually during the FDA’s designated window, typically between October 1 and December 31. This ensures that the FDA maintains accurate, current records of all establishments handling OTC drug products. The information submitted includes facility details and a comprehensive list of the OTC drugs produced or handled.

The purpose of this registration is to enable the FDA to monitor manufacturing practices, conduct facility inspections, and manage product recalls effectively. Noncompliance with FDA OTC Drug Registration can lead to enforcement actions such as import refusals, product seizures, and warning letters, potentially causing significant disruptions in the supply chain.

In addition to facility registration, every OTC drug product must have a National Drug Code (NDC) assigned through FDA NDC Registration. The NDC is a unique numeric identifier that facilitates the identification, tracking, and management of drug products in the U.S.

The NDC consists of three segments:

Labeler Code: Identifies the company responsible for the drug.

Product Code: Defines the product’s strength, dosage form, and formulation.

Package Code: Specifies packaging details, such as size and type.

The NDC system is widely used by pharmacies, wholesalers, insurers, and healthcare providers for inventory management, billing, and dispensing. Without a valid NDC, an OTC drug cannot be legally marketed or sold in the U.S., which underscores the critical importance of FDA NDC Registration.

While FDA OTC Drug Registration confirms the legitimacy and regulatory compliance of the facilities involved, FDA NDC Registration provides a unique identifier for each OTC drug product. Together, these registrations ensure that OTC products meet FDA standards, are traceable, and are legally marketable.

Benefits include:

Legal authorization to distribute OTC drug products in the U.S.

Enhanced consumer safety through effective tracking and recall capability.

Streamlined supply chain management and reimbursement processes.

Protection against regulatory actions and penalties.

Skipping either registration exposes companies to significant risks, including regulatory enforcement, financial losses, and damage to brand reputation.

For any business dealing with OTC drug products, completing FDA OTC Drug Registration and FDA NDC Registration is fundamental to regulatory compliance and market success. These registrations guarantee that both facilities and products meet FDA requirements, promoting safety, transparency, and legal distribution. Staying compliant not only helps avoid costly penalties but also builds consumer trust and supports business growth. Working with regulatory experts can simplify the registration processes and ensure that companies maintain adherence to all FDA regulations efficiently.