Over-the-Counter (OTC) Medications

The United States has more than 80 classes of over-the-counter (OTC) medications. OTC drugs are considered safe and effective for public use without requiring consultation from a healthcare professional. Consumers can follow the directions on the Drug Facts Label for proper use.

OTC medicines treat a wide range of symptoms and conditions, including pain, coughs and colds, diarrhea, heartburn, constipation, acne, fungal infections, and weight management. These medications are readily available in pharmacies, grocery stores, convenience stores, and through online retailers.

Common OTC medications include pain relievers such as acetaminophen (Tylenol) and ibuprofen (Advil, Motrin IB), cough suppressants like dextromethorphan (Robitussin), and antihistamines such as loratadine (Claritin 24H). Recent additions include Narcan, an opioid overdose reversal nasal spray available since 2023, and Opill, the first FDA-approved over-the-counter oral contraceptive in the U.S., expected to be available in 2024.

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More information about OTC products

What is an Rx-to-OTC switch?

Many OTC drugs have undergone a prescription to over-the-counter switch -- also known as "Rx-to-OTC switch" -- meaning they were previously available only with a prescription but now can be bought as a nonprescription product. For example, proton-pump inhibitors like esomeprazole (Nexium 24HR) and stomach acid blockers like famotidine (Pepcid AC), both used for heartburn, are examples of products that have made the Rx-to-OTC switch. Nasonex 24HR Allergy, as nasal spray for symptoms due to hay fever became available OTC in 2022. The emergency contraceptive pill ("the morning-after pill") known as Plan B One Step is now available OTC without age restriction and can be found on the shelves in many pharmacies in the U.S.

In 2023, several medications were approved for OTC use, including: Narcan and RiVive, naloxone nasal sprays for the emergency treatment of opioid (narcotic) overdose, and Opill, a progestin only oral birth control pill and the first birth control pill available without a prescription in the U.S.

Which drugs are kept behind the pharmacy counter?

A more restricted class of OTC drugs also exists. These products, while considered OTC, are kept behind the pharmacy counter and are dispensed by a pharmacist.

Some products, such as pseudoephedrine (Sudafed), an oral decongestant which is subject to abuse, may require proper identification and a signature, or a prescription from your doctor, depending upon state laws. Some states allow codeine-containing cough syrup, a schedule 5 controlled substance, to be purchased from behind the counter, but most states require a prescription.

Phenylephrine, another oral decongestant, but one that is not kept behind the counter, was found to be ineffective at the current OTC dose by the FDA at a September 2023 meeting. However, there was no concern over safety issues with the active ingredient. While the FDA has not removed phenylephrine from the U.S. market, at least one national pharmacy, CVS, will no longer sell products that contain phenylephrine as the sole ingredient.

Some types of insulin, such as Novolin N (insulin isophane) and Humulin R (insulin regular) are also available from a pharmacist behind the pharmacy counter (so the pharmacist can counsel you on their use). Insulin, while a life-saving therapy, can also be dangerous if used inappropriately and lead to high or low blood sugars.

Always check with your doctor before you switch types of insulin.

Rules for behind-the-counter medicines often vary by state or local regulation, and may include restrictions like age, proof of identification, or quantity dispensed. Your pharmacist can tell you the specific laws for your state.

How does the FDA review over-the-counter (OTC) drugs?

The review of OTC medications is primarily handled by the U.S. Food and Drug Administration's (FDA) Division of Drug Information (CDER), the Office of Drug Evaluation, and the Nonprescription Drug Advisory Committee. These teams evaluate and review OTC ingredients and labels.

An OTC drug monograph is established for each class of product. The monograph contains acceptable ingredients, doses, formulations, and labeling. New products that conform to an existing OTC drug monograph may be marketed without further FDA review. Those OTC products that do not conform to an OTC monograph must undergo approval through the FDA's New Drug Approval System.

Are over-the-counter (OTC) drugs safe to use?

Most OTC medicines are safe to use when the package directions are followed, but they can still carry a risk, even though they do not require a prescription. There is the possibility of side effects, drug interactions, or harm due to excessive doses.

Consumers should read the "Drug Facts" label that is found on all OTC products or in the package and follow those instructions. For any questions you have about an OTC medicines, herbal product or dietary supplement, ask your doctor or pharmacist. Pregnant women should speak with their doctor first before taking any medication, vitamin, or herbal supplement, even if it's an OTC product.