About FDA
What are over-the-counter (OTC) drugs and how are they approved?
OTC drugs are drugs that have been found to be safe and appropriate for use without the supervision of a health care professional such as a physician, and they can be purchased by consumers without a prescription. These drugs are sometimes approved under applications like new prescription drugs, but more often they are legally marketed without an application by following a regulation called an OTC drug monograph.
An OTC drug monograph tells what kind of ingredients may be used to treat certain diseases or conditions without a prescription, and the appropriate dose and instructions for use. OTC products that meet a monograph’s requirements may be marketed without FDA review. OTC products that do not fit under an existing monograph must be approved under an application like the applications for prescription products.
- Where can I find information about adverse reactions to a medicine prescribed for my child?
- Where can I find information about medicines prescribed for my child?
- Materials from Webinar on Access to Investigational Drugs
- FDA Basics Webinar: "Mini-Sentinel," FDA's New Tool for Monitoring the Safety of FDA-Approved Medical Products
- How FDA Evaluates Regulated Products: Drugs
- FDA Webinar on Prescription Drug Shortages
- FDA Webinar on "Bad Ads" Program
- FDA Basics Webinar on Generic Drugs
- FDA Basics Videos: Tim Coté on Orphan Drugs
- What is an FDA Drug Safety Communication?
- What is counterfeit medicine?
- FDA Basic Video: Interview with John Jenkins on New Drugs (Video)
- What are unapproved drugs and why are they on the market?
- How can I stay better informed about drugs? Is there a reliable website FDA recommends?
- How do I discard medicine that I no longer need, do I just throw it in the garbage?
- How do I report a bad reaction to medicine or medication error to FDA?
- Does FDA approve the proprietary names of prescription drugs?
- What does FDA require drug manufacturers to do to prevent contaminated drugs? If contamination occurs, how must they correct the problem?
- How does FDA help consumers when drug shortages happen?
- Does FDA approve the information given out by pharmacies when I pick up my medicine?
- How does FDA decide when a drug is not safe enough to stay on the market?
- How do I find out if a drug is approved? Is there a Web site I can go to?
- What is the approval process for a new prescription drug?
- What is a Warning Letter?
- Can FDA ban direct-to-consumer drug advertising?
How helpful was this information?