Rx to OTC: 5 drugs that went from prescription to over-the-counter

Are you curious about how some medicines, once available only by prescription, end up on your local pharmacy shelves for anyone to purchase? The U.S. Food and Drug Administration (FDA) has a well-defined process for this transformation, known as the Prescription-to-Nonprescription (RX-to-OTC) switch. Let’s explore what this process entails and spotlight five notable drugs that have made the leap from prescription-only to over-the-counter (OTC) availability.

What’s an RX-to-OTC switch?

The FDA’s RX-to-OTC switch allows certain medications, once proven safe and effective for use without a healthcare provider’s supervision, to be sold directly to consumers. This transition can make important treatments more accessible and convenient for millions.

Types of Rx-to-OTC switches

• Full Switch: The medication moves completely to nonprescription (OTC) status under its New Drug Application (NDA), meaning it is sold only as an OTC product.
• Partial Switch: Only some uses of the drug become OTC after submitting a new NDA, while other uses remain prescription-only. For example, a medication may be sold OTC at lower strengths or for specific indications, but still require a prescription for higher doses or other conditions.

The process typically takes around 10 months, though the timeline can vary if additional data or studies are requested by the FDA.

5 drugs that made the Rx-to-OTC switch

• Differin®, a gel to treat acne, was approved as a prescription medicine in 1996. It became OTC in 2016 and was the first OTC acne product with a full prescription-strength retinoid, a type of compound that comes from vitamin A. According to Galderma, its maker, it was also “…the first new, FDA-approved active ingredient to be introduced to the OTC acne category in over three decades.”
• Narcan® was approved by the FDA in 1971 as an injection given by healthcare professionals. In 2015, a different version of it—a nasal spray—was approved by the FDA, but a prescription was needed to get it. The nasal spray can reverse an opioid overdose. In March 2023, it was approved as OTC and was on the market in September 2023.
• Nasonex is a nasal spray that lowers inflammation in the nose, treating the symptoms of allergies. It was approved in 1997. Nasonex became OTC in 2022 under the name “Nasonex® 24HR Allergy.”
• Opill® is a nonprescription oral birth control pill that is progestin only. It is the first FDA-approved OTC birth control pill and was approved as OTC in 2023. Opill was initially approved by the FDA in prescription form in 1973, but had not been available since 2005 because its maker stopped selling it.
• Voltaren® gel for treatment of joint pain from osteoarthritis was first approved in 2007. It became OTC in 2020 and is marketed as “Voltaren Arthritis Pain.” The gel is the same strength as the prescription.

Further reading

• What’s in a name? An overview of the drug naming process
• Drug shortages: Q3 2025 Update
• Pharmacy deserts: A growing problem in the U.S.

References

• Prescription-to-Nonprescription (Rx-to-OTC) Switches. Food and Drug Administration. June 28, 2022.
• FAQs About Rx-to-OTC Switch. Consumer Healthcare Products Association.
• Topical retinoid acne treatment approved for OTC use. AAP News. 2016.
• Galderma Announces FDA Approval of Full Prescription-Strength Differin® Gel For Over-the-Counter Acne Use. Galderma. July 8, 2016.
• West, Mary. What to know about retinoids. Medical News Today. July 29, 2021.
• FDA Approves First Over-the-Counter Naloxone Nasal Spray. Food and Drug Administration. March 29, 2023.
• Gragnolati, Amy B. Narcan Distribution: How the U.S. Is Making This Lifesaving Medication More Accessible. GoodRx. October 6, 2023.
• Murdock, Joshua. OTC Narcan Is Here: FDA Expands Access to Life-Saving Opioid Overdose Treatment. GoodRx. September 8, 2023.
• Mometasone Nasal Spray. Cleveland Clinic.
• Drug Approval Package. Nasonex (Mometasone Furoate). Food and Drug Administration.
• FDA Approves Nasonex 24HR Allergy (mometasone furoate) Nasal Spray for OTC Use. Drugs.com. March 17, 2022.
• Opill (0.075mg Oral Norgestrel Tablet) Information. Food and Drug Administration. January 16, 2024.
• Five Things to Know About Opill, the First FDA-Approved Over-the-Counter Birth Control Pill. NYU Langone Health. March 18, 2024.
• Hilkowitz, Mia. FDA approves first over-the-counter birth control pill in U.S. Indiana Daily Student. July 16, 2023.
• Voltaren Gel FDA Approval History. Drugs.com. April 7, 2021.
• Brody, Barbara. Voltaren Available Over the Counter: 9 Questions and Answers for Arthritis Patients. Creaky Joints. July 8, 2020.

Learn more

Want to learn more about how we help create pharmacy value and improve patient outcomes? Contact us by filling out the form below.