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  5. Over-the-Counter (OTC) Drug Product Review Process
  1. CDER Small Business & Industry Assistance (SBIA)

Over-the-Counter (OTC) Drug Product Review Process

Over-the-counter drugs are defined as drugs that are safe and effective for use by the general public without a prescription. OTC drug products are those drugs that are available to consumers without a prescription. More than 100,000 OTC drug products are marketed, encompassing about 800 significant active ingredients. There are more than 80 classes (therapeutic categories) of OTC drugs, ranging from acne drug products to weight control drug products. As with prescription drugs, the Center of Drug Evaluation and Research (CDER) oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks. The following links provide useful information about the OTC drug review process.

  • Drug Applications for Over-the-Counter Drugs. Links to information about OTC labeling and warning, guidances, Federal Register publications, and more.
  • Frequently Asked Questions on the Regulatory Process of OTC Drugs (4/5/2004)
  • Division of NonPrescription Products webpage, contact information, and addresses  
  • Status of OTC Rulemakings. The OTC drug category web site contains Federal Register notices organized by therapeutic category subtopics. Each web page also links to therapeutic category pages organized chronologically.
  • OTC Ingredient Status Report: This report lists every ingredient reviewed by the FDA for safety and effectiveness as an active ingredient in the OTC drug review. Once you have identified the monograph under which the ingredient was reviewed, refer to the "Index of Significant OTC Drug FEDERAL REGISTER Publications by OTC Report." This report is partially available on the FDA website.
  • Index of Significant OTC Drug FEDERAL REGISTER Publications by OTC Report disclaimer icon: The most recent listing available is dated August 3, 2006. This report provides the date and FEDERAL REGISTER citation for each monograph published. You can obtain individual ingredient information by requesting a copy of each FEDERAL REGISTER publication from the Drug Information Group (address to follow). Final monographs are also published in the "Code of Federal Regulations," available in most libraries, or can be accessed via the Internet.
  • FDA "Approved Drug Products with Therapeutic Equivalence Evaluations," commonly referred to as the "Orange book." The Orange book contains information about OTC drug products approved under the new drug review that may not be listed in existing OTC drug monographs.