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7 Differences Between Over-the-Counter and Prescription Medications Everyone Should Know

Veneta LuskStacia Woodcock, PharmD
Written by Veneta Lusk | Reviewed by Stacia Woodcock, PharmD
Updated on November 12, 2024

Key takeaways:

  • Over-the-counter (OTC) medications allow you to self-treat conditions such as allergies, headaches, joint pain, and more. Prescription medications require an order from a healthcare professional.

  • You can buy OTC treatments at supermarkets, drugstores, and other retail locations. Prescription medications must be purchased from a licensed pharmacy.

  • Some medications are available both OTC and by prescription, but the formulations aren’t always the same. It’s best to check with your pharmacist or other healthcare professional to determine which version of a medication you should take.

A customer in a pharmacy aisle reaching for an OTC medication.
Yuri_Arcurs/iStock via Getty Images Plus

If you have a headache or heartburn, you may wonder if you need an over-the-counter (OTC) medication or a prescription treatment. You can find OTC options at grocery stores, drugstores, convenience stores, gas stations, and more. But for more serious or long-lasting symptoms, your healthcare professional may advise you to take a prescription medication, which must be dispensed at a pharmacy. 

In recent years, many treatments that once required a prescription have become available OTC. This is because of a process called the Rx-to-OTC switch — with “Rx” being shorthand for “prescription”. Below are examples of medications that have undergone the Rx-to-OTC switch: 

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Prescription and OTC versions of the same medication may differ slightly. So even when you have the choice between going to the grocery store or the pharmacy for your medication, it’s a good idea to talk to your healthcare professional. And you can find out more about the distinctions between OTC and prescription medications below.

What does over the counter mean?

Over-the-counter, or OTC, medications can be accessed without a prescription. They’re different from medications that are kept behind-the-counter (BTC), which you have to get from pharmacy staff members but don’t require a prescription. OTC medications are available at a variety of retail locations and can be picked up off of store shelves or purchased online.

In addition to grocery stores and convenience stores, OTC medications are also available at pharmacies. Keep in mind that in addition to counseling you about prescriptions, pharmacists also can offer advice on OTC and BTC medications. So don’t hesitate to ask questions if you’re unsure about the best OTC treatment option for your needs.

In most cases, it’s OK for more than one person to use the same OTC medications, such as a bottle of ibuprofen for everyone in a household to take as needed.

What is a prescription medication?

Prescription medications require an order from a healthcare professional. Each prescription is written for a specific person, so a prescription medication shouldn’t be shared with anyone else. Prescription medications are usually filled at a pharmacy for use at home, but sometimes they’re filled and/or administered in a healthcare setting, such as in a hospital or a prescriber’s office.

Why are some medications OTC while others are only available by prescription?

The FDA decides whether a medication should be available OTC or by prescription based on its safety profile. Factors that determine this decision include:

  • Chance of interactions with other medications

  • Overdose risk

  • Side effects

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Prescription medications often have a higher potency than OTC options and potential interactions with certain foods or other medications. Meanwhile, OTC treatments typically have low toxicity and a low risk of serious side effects. These medications are also easy to take for self-diagnosed conditions. They have clear labeling that includes directions for taking them as well as information about uses and warnings.

How do OTC and prescription medications differ?

Understanding the differences between OTC and prescription medications can help you decide if you need a prescription from a healthcare professional or if you can pick up something from the store. Here are seven important distinctions between OTC and prescription medications.

1. FDA approval process

Whether a medication is available OTC or by prescription depends on the safety of its active ingredients. 

It’s important to understand that both prescription and OTC products must meet FDA standards for safety, quality, and effectiveness. But the FDA regulates OTC and prescription medications in different ways. Prescription medications go through the new drug application (NDA) process, which requires pharmaceutical companies to submit clinical trial data and information about the manufacturing process. Prescription medication manufacturers also have to submit details about how the medication works in the human body, guidelines for dosages, and information on safety and side effects.

OTC medications can be approved by the FDA to go on the market through the OTC drug monograph process or the NDA process. These pathways determine a medication’s: 

  • Acceptable ingredients

  • Dosages

  • Formulations

  • Labeling requirements 

As long as an OTC medication completes one of those processes, it can be marketed and sold without any further review or approval from the FDA. OTC medications must meet certain standards to ensure that they are safe and effective, such as:

  • Having benefits that outweigh any risks

  • Having low potential for misuse

  • Being usable for self-diagnosed conditions

  • Carrying labeling that is clear and understandable

2. Conditions they treat

OTC medications are typically intended for conditions that are easy to self-diagnose and safe to self-treat. Prescription medications treat health conditions that are complex or hard to self-diagnose. They are also easy to misuse.

3. Who can use them

Prescription medications are intended to be used only by the person to whom they were prescribed. OTC medications are often shared by several people, such as when a family has a bottle of Advil (ibuprofen) or Tylenol (acetaminophen) for household use. Though, it’s important to note that, while OTC medications in tablet or topical form are generally safe to share, OTC products such as nasal sprays are best kept for individual use.

4. Cost

The costs of prescription and OTC medications can vary. For prescription medications, the amount you pay often depends on whether you have insurance. 

With insurance, the price of a prescription medication also depends on:

  • Whether you have met your deductible

  • The amount of your copay or coinsurance

  • Available manufacturer discounts

If you don’t have insurance or are not using your insurance to purchase a prescription medication, the cost can depend on your access to patient assistance programs or savings with a GoodRx coupon.

Sometimes, it’s possible to get certain prescription medications or refills with a phone call to a healthcare professional, but an in-person or virtual visit with a prescriber is often required. So you’ll have to factor what you pay for a medical visit into the cost of your prescription as well.

OTC medications can cost less than prescription medications, but this is not always the case. You may be able to save money on OTC medications with coupons or by buying a store-brand version instead of a name-brand version. You can also use a health savings account (HSA), flexible spending account (FSA) or health reimbursement arrangement (HRA) to purchase OTC products, which reduces your spending through tax savings.

5. Access

Prescription medications typically can be dispensed only from a pharmacy by a licensed pharmacist. OTC medications, on the other hand, are usually freely available at many different kinds of retailers. 

However, there are some OTC treatments — such as cold or allergy medications that contain pseudoephedrine (Sudafed) — that are kept behind the counter. These medications typically have quantity limits or age restrictions and require identification to purchase them. 

6. Labeling

Labeling requirements also differ for prescription and OTC medications. When you’re prescribed a medication, your healthcare professional determines your dose, quantity, and how you should take the medication. This information is included on the prescription and the medication label.

Unlike prescription medications, OTC medications must have consumer-friendly labeling that’s easy to understand. This way, a person can treat their symptoms by reading and following the guidelines on the label. OTC labeling must include details about:

  • Active ingredients and amounts

  • What the medication treats

  • Directions for use

  • Warnings about potential side effects or interactions

7. Potency

Prescription medications are usually more powerful than OTC treatments. That’s one reason why they require the official recommendation and guidance of a healthcare professional to make sure they’re taken safely. 

OTC medications have a wider safety margin than prescription medications. They’re usually used to treat common, minor illnesses, such as allergies or constipation.

Some OTC medications are available at a higher strength with a prescription. For example, topical hydrocortisone cream is available OTC in 1% potency or lower. But there are 2% and 2.5% formulations that require a prescription.

The bottom line

Often, you can pick up an over-the-counter (OTC) medication to treat common problems such as headaches, heartburn, or allergies. In other cases, you’ll need to see a healthcare professional for a prescription medication. Whether a medication is OTC or prescription depends on its safety profile. And there are some other notable differences to consider.

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Veneta Lusk
Written by:
Veneta Lusk
Veneta Lusk is a personal finance and healthcare writer with 15 years of experience. She holds a bachelor of arts in journalism from the University of North Carolina at Chapel Hill.
Cindy George, MPH
Cindy George is the senior personal finance editor at GoodRx. She is an endlessly curious health journalist and digital storyteller.
Stacia Woodcock, PharmD
Stacia Woodcock, PharmD, is a pharmacy editor for GoodRx. She earned her Doctor of Pharmacy degree from the University of Kentucky and is licensed in New York and Massachusetts.

References

Congressional Research Service. (2021). ​​FDA regulation of over-the-counter (OTC) drugs: Overview and issues for Congress.

U.S. Food and Drug Administration. (2016). Approved drugs: Questions and answers.

View All References (5)

U.S. Food and Drug Administration. (2016). How FDA strives to ensure the safety of OTC products.

U.S. Food and Drug Administration. (2017). Prescription drugs and over-the-counter (OTC) Drugs: Questions and answers.

U.S. Food and Drug Administration. (2017). The FDA's drug review process: Ensuring drugs are safe and effective.

U.S. Food and Drug Administration. (2023). Over-the-counter OTC | nonprescription drugs.

U.S. Food and Drug Administration. (2024). The over-the-counter drug facts label.

GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.

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