Key takeaways:
Some medications are able to transition from prescription-only (Rx) to being sold over the counter (OTC). This is referred to as an Rx-to-OTC switch.
When an Rx-to-OTC switch occurs, it offers a convenient alternative. Commonly, these medications can help you treat allergies, joint pain, and heartburn. Medications for overactive bladder, acne, and birth control have also made the switch.
OTC versions of prescription medications aren’t always the same. Be sure to double check with your prescriber or pharmacist.
If you experience frequent heartburn, you may pick up a medication like omeprazole (Prilosec OTC) from your local pharmacy aisles for relief. But it wasn’t always this easy. Before 2003, omeprazole was only available with a prescription.
Sometimes, such as the case with omeprazole, prescription medications transition to being sold over the counter (OTC). This is referred to as a Rx-to-OTC switch. When this happens, it offers convenient options for you to self-treat a number of ailments — from itchy eyes to yeast infections.
So, how exactly does a Rx-to-OTC switch work? And which products have gone through the process?
The Rx-to-OTC switch process involves rigorous review and approval by the FDA. And the process can look slightly different, depending on whether it’s a full or partial switch. A full switch means the prescription and OTC products have the same approved uses. But uses can be different with a partial switch.
Through this process, the FDA determines if the medication will be safe and effective for OTC use. In other words, consumers should be able to understand how to use it to treat their symptoms without a prescriber. This includes simple, clear, and easy-to-understand labeling. In some cases, the prescription product may still be required for a specific use.
Below, we’ll discuss 13 examples of medications that have made the switch from prescription-only to OTC.
Nasonex (mometasone furoate) is a steroid nasal spray. It works by reducing inflammation and swelling in your nose. In March 2022, it made the switch from prescription-only to OTC. The steroid nasal sprays Flonase (fluticasone) and Nasacort (triamcinolone) had made the switch a few years earlier.
The prescription version of Nasonex is approved to prevent nasal symptoms (like congestion) from seasonal allergies in people ages 12 and older. It’s also used to treat nasal polyps in adults ages 18 and older.
The OTC version is called Nasonex 24 HR Allergy. It can be used for the temporary relief of nasal allergy symptoms in adults and children ages 2 and older.
Lastacaft (alcaftadine) eye drops are used to help relieve itchy eyes caused by allergies. It's an antihistamine approved for use in people ages 2 and older. Blocking histamine release is important to managing allergy symptoms.
Lastacaft’s switch happened in December 2021. And the OTC product is the same as the prescription version.
Astepro (azelastine) is an antihistamine nasal spray. The switch to OTC went into effect in 2021. It became the first non-steroid OTC nasal spray for allergies.
The prescription Astepro product is approved to treat seasonal allergy symptoms in people ages 5 and older. It can also treat symptoms like nasal congestion and a runny nose that aren’t related to allergies in people ages 12 and older.
The OTC version is called Astepro Allergy. It’s used to provide temporary relief of nasal allergy symptoms in people ages 6 and older.
Voltaren Gel (diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID). It comes as a topical gel you can apply to relieve arthritis pain caused by inflammation. You can use it on upper body areas (hands, wrists, elbows) or lower body areas (foot, ankle, knee).
Voltaren Gel made the switch to OTC in 2020. You can now find it on pharmacy shelves as Voltaren Arthritis Pain. The OTC version is the same as the prescription product.
Pataday (olopatadine) is an antihistamine and mast cell stabilizer eye drop used to relieve itchy eyes from allergies. Before making the switch, olopatadine eye drops were available as three different prescription products: Pazeo (extra-strength), Pataday (once-daily), and Patanol (twice-daily).
OTC versions of all three products were approved in 2020. And they were rebranded for OTC use under the following names: Pataday Once Daily Relief Extra Strength, Pataday Once Daily Relief, and Pataday Twice Daily Relief.
Zaditor (ketotifen) and Alaway (ketotifen) are two antihistamine and mast cell stabilizer eye drops that made the switch 14 years before Pataday.
Plan B (levonorgestrel) is a form of emergency contraception. It was first approved in 1999 as a prescription product that included two tablets, taken 12 hours apart. But the sooner you take Plan B, the more effective it’ll be. This made it a prime candidate for an Rx-to-OTC switch to improve faster access to the medication.
Plan B made the switch to OTC in 2006. But only women ages 18 and older could purchase it. Three years later, Plan B One-Step was approved OTC for women ages 17 and older. With Plan B One-Step, you only need to take one tablet. As of 2013, you can purchase it without age restrictions.
Opill (norgestrel) is a once-daily birth control pill. Norgestrel is a type of progestin (a lab-made form of the sex hormone progesterone). It was originally FDA approved in 1973 and remained on the market as a prescription-only medication until 2005. Due to a lack of popularity, the manufacturer stopped producing it.
Nearly two decades later in 2023, the FDA approved Opill as the first OTC birth control pill. This OTC switch was a huge step in helping more women have better access to effective contraception.
Xyzal (levocetirizine) is an oral antihistamine. Levocetirizine is similar to the active component of another OTC antihistamine called Zyrtec (cetirizine), which made the switch to OTC in 2007.
The prescription version of Xyzal is approved to treat allergy symptoms and chronic hives in people ages 6 and older. OTC versions of the tablets and liquid were approved in 2017 to help alleviate allergy symptoms only.
In addition to Zyrtec, Claritin (loratadine) and Allegra (fexofenadine) are other antihistamines that had previously switched to OTC.
Differin Gel (adapalene) is a topical treatment for acne. It belongs to a group of medications called retinoids, which are derived from vitamin A. Differin Gel became the first retinoid approved for OTC use when it made the switch in 2016.
However, only the lower strength (0.1%) gel was approved for OTC use. The higher strength (0.3%) gel still requires a prescription.
Prilosec (omeprazole) is a proton pump inhibitor (PPI). It works by reducing acid production in your stomach. Prilosec became the first PPI approved for OTC use in 2003. Six years later, the PPIs Zegerid (omeprazole/sodium bicarbonate) and Prevacid (lansoprazole) also made the switch for frequent heartburn.
The prescription version of Prilosec is approved to treat several medical conditions in adults and children that require medical supervision. Examples of these include certain types of ulcers and gastroesophageal reflux disease (GERD). It’s available in 10 mg, 20 mg, and 40 mg dosages.
Prilosec OTC is only approved for the short-term treatment of frequent heartburn in adults. And it’s only available as 20 mg tablets and capsules. If you’re still experiencing heartburn after taking Prilosec OTC for 14 days, speak with your prescriber.
Nexium (esomeprazole) is the latest PPI to make the switch. Similar to Prilosec, the prescription version of Nexium has different approved uses and dosages than the OTC product.
Nexium 24 HR, the OTC version, is also only approved for frequent heartburn in adults. And it’s only available as a 20 mg dosage.
Oxytrol (oxybutynin) is a topical patch to help control the symptoms of an overactive bladder. It works by relaxing the muscles in your bladder.
Oxytrol’s situation was unusual for an Rx-to-OTC switch. That’s because the OTC product was only approved for use in women. In fact, the OTC version is called Oxytrol For Women. Men with the same symptoms still require a prescription.
One of the reasons for this is that overactive bladder symptoms may be a sign of a more serious condition in men, like prostate cancer. At the time, there were concerns that self-treating these symptoms with Oxytrol might delay diagnosis in men.
Narcan (naloxone) is a nasal spray used to reverse an opioid overdose. It was originally FDA approved in 1971 as an injection that was administered by paramedics and healthcare professionals in hospital settings. With the growing number of opioid overdoses since then, researchers focused on making Narcan easier to use and access.
In 2015, the nasal spray version of Narcan was FDA approved but required a prescription to obtain. In the years that followed, many laws were passed across the U.S. to help people access Narcan without needing to see a prescriber. And in 2023, the FDA approved Narcan for OTC sale. A few months later, RiVive was approved as the second OTC naloxone product. RiVive is also a nasal spray, but contains a slightly different dose of naloxone than Narcan.
Rx-to-OTC switches offer convenient access to medications. They allow you to self-treat symptoms of allergies, heartburn, and more without needing to see your prescriber.
But not all over-the-counter (OTC) products are the same as their prescription versions. In some cases, the prescription medication is required to treat a more serious medical condition. And many OTC products are only meant for short-term use. If you need to take them longer, you should contact your healthcare provider.
A-S Medication Solutions. (2023). Plan B one-step [package insert].
Alcon. (2020). Alcon announces FDA approval of the OTC switch of pataday once daily relief extra strength.
Alcon Laboratories, Inc. (2022). Pataday once daily relief [package insert]. DailyMed.
Alcon Laboratories, Inc. (2023). Pataday once daily relief [package insert]. DailyMed.
Alcon Laboratories, Inc. (2023). Pataday twice a day relief [package insert]. DailyMed.
Allergan, Inc. (2020). Lastacaft [package insert].
Allergan, Inc. (2022). Lastacaft [package insert]. DailyMed.
Allergan, Inc. (2016). Oxytrol for women [package insert]. DailyMed.
Allergan, Inc. (2023). Oxytrol [package insert]. DailyMed.
Apotex Corp. (2023). Mometasone furoate spray [package insert]. DailyMed.
AstraZeneca Pharmaceuticals LP. (2023). Nexium [package insert].
AvKARE. (2024). Azelastine hydrochloride - azelastine spray, metered [package insert].
Bausch & Lomb Incorporated. (2022). Alaway [package insert]. DailyMed.
Bayer Healthcare LLC. (2023). Astepro allergy [package insert]. DailyMed.
Chattem, Inc. (2024). Childrens Xyzal allergy [package insert]. DailyMed.
Chattem, Inc. (2024). Xyzal allergy 24hr [package insert]. DailyMed.
Galderma Laboratories, L.P. (2022). Differin [package insert]. DailyMed.
Galderma Laboratories, L.P. (2023). Differin - adapalene gel [package insert].
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. (2023). Nexium 24HR [package insert]. DailyMed.
Haleon US Holdings LLC. (2024). Voltaren arthritis pain [package insert]. DailyMed.
L. Perrigo Company. (2023). Nasonex [package insert]. DailyMed.
Meijer, Inc. (2022). 24 Hr omeprazole [package insert]. DailyMed.
Micro Labs Limited. (2021). Levocetirizine dihydrochloride [package insert]. DailyMed.
Murry, K. M. (2023). New drug application 17031 supplement 41 application for full prescription-to-nonprescription switch of norgestrel tablets 0.075 mg. U.S. Food and Drug Administration.
National Association for Continence. (n.d.). Overactive bladder in men.
Office on Women’s Health. (2020). Approval of emergency contraception.
Preferred Pharmaceuticals, Inc. (2023). Diclofenac sodium [package insert]. DailyMed.
Remedyrepack Inc. (2023). Omeprazole - omeprazole capsule, delayed release [package insert].
U.S. Food and Drug Administration. (2015). Prilosec OTC (omeprazole) information.
U.S. Food and Drug Administration. (2002). New drug application (NDA): 016636.
U.S. Food and Drug Administration. (2022). Plan B One-Step (1.5 mg levonorgestrel) information.
U.S. Food and Drug Administration. (2022). Prescription-to-nonprescription (Rx-to-OTC) switches.
U.S. Food and Drug Administration. (2023). FDA approves second over-the-counter naloxone nasal spray product.
U.S. Food and Drug Administration. (2023). New drug application (NDA): 017031.
U.S. Food and Drug Administration. (2023). New drug application (NDA): 208411.
U.S. Food and Drug Administration. (2023). Prescription to over-the-counter (OTC) switch list.
Walmart Inc. (2022). Equate omeprazole [package insert]. DailyMed.
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