About FDA

Why are some drugs available as both a prescription and an over-the-counter drug?

A medication that is marketed as both a prescription medication and an OTC medicine may contain the same active ingredient; however, the dosage strength and form, the dosing regimen or the indications may differ between the prescription and the OTC versions. For example, the prescription version of the drug may come in a higher strength and may have to be taken more often than the OTC version of the drug.  When a medicine is available as both prescription and OTC, it is usually first approved as a prescription drug, and the company later applies to have an OTC version approved.

Rate this page

1 (Not Helpful) → 5 (Very Helpful)

(Limit your feedback to 1000 characters.)

(Limit your feedback to 1000 characters.)

If you would like to ask a specific question, please visit our "Contact Us" page for more information about how to contact FDA.

Please note that any information you submit may become public or subject to release under the Freedom of Information Act (FOIA). For more information, read about our privacy policies and the FOIA.

Page Last Updated: 09/28/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.