Over-the-counter (OTC) drugs are products that can be obtained without a prescription. These drugs can be found in the aisles of a pharmacy, grocery store, or gas station. Common OTC drugs include Advil and Tylenol for pain, Zyrtec and Claritin for allergies, and Robitussin for cough. Marketing an OTC drug, requires compliance with an OTC drug monograph, or under the authority of an approved product through a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or a Biologics License Application (BLA).
The Orange Book Database contains information on all FDA-approved drug products as well as patent and exclusivity information. It consists of four main parts including The Prescription Drug Product List, The OTC Drug Product List, The Drug Products with Approval under Section 505 of the FD&C Act Administered by the Center of Biologics Evaluation and Research List, and The Discontinued Drug Product List.