Over-the-Counter Drugs

Topic

A category of non-prescription medications. The FDA aims to move more drugs into this category to increase price transparency, competition, and access while bypassing PBMs.


First Mentioned

1/16/2026, 4:43:42 AM

Last Updated

1/16/2026, 4:48:44 AM

Research Retrieved

1/16/2026, 4:48:44 AM

Summary

Over-the-counter (OTC) drugs are medications sold directly to consumers without a prescription, regulated by agencies like the FDA to ensure safety and efficacy for use without professional medical supervision. They cover more than 80 classes of medications in the United States, including pain relievers, antihistamines, and more recently, emergency treatments like Narcan and oral contraceptives like Opill. Under the Donald Trump administration, FDA Commissioner Marty Makary has prioritized moving more prescription drugs to OTC status as a key strategy to lower drug prices and bypass the opaque system of Pharmacy Benefit Managers (PBMs). This process, known as an 'Rx-to-OTC switch,' is intended to increase market competition and consumer access while reducing healthcare costs.

Referenced in 1 Document
Research Data
Extracted Attributes
  • Common Examples

    Acetaminophen, Ibuprofen, Loratadine, Dextromethorphan

  • Alternative Name

    Non-prescription drugs

  • Number of Classes (US)

    More than 80

  • Primary Goal of Expansion

    Lowering drug prices and bypassing PBMs

  • Regulatory Authority (US)

    Food and Drug Administration (FDA)

Timeline
  • Nasonex 24HR Allergy nasal spray becomes available over-the-counter. (Source: Drugs.com)

    2022-01-01

  • Narcan, an opioid overdose reversal nasal spray, becomes available for OTC purchase. (Source: Drugs.com)

    2023-01-01

  • Opill, the first FDA-approved over-the-counter oral contraceptive in the U.S., is expected to be available. (Source: Drugs.com)

    2024-01-01

  • FDA Commissioner Marty Makary outlines a major initiative at the JP Morgan Healthcare Conference to move more drugs to OTC status to lower prices. (Source: Document 065d2e96-4d40-49bd-8511-d8d35f8b01f4)

    2025-01-13

Over-the-counter drug

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) and strengths of final products. The term over-the-counter (OTC) refers to a medication that can be purchased without a medical prescription. In contrast, prescription drugs require a prescription from a doctor or other health care professional and should only be used by the prescribed individual. Some drugs may be legally classified as over-the-counter (i.e. no prescription is required), but may only be dispensed by a pharmacist after an assessment of the patient's needs or the provision of patient education. Regulations detailing the establishments where drugs may be sold, who is authorized to dispense them, and whether a prescription is required vary considerably from country to country.

Web Search Results
  • Over-the-counter drug - Wikipedia

    Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) and strengths of final products. [...] The term over-the-counter (OTC) refers to a medication that can be purchased without a medical prescription. In contrast, prescription drugs require a prescription from a doctor or other health care professional and should only be used by the prescribed individual. Some drugs may be legally classified as over-the-counter (i.e. no prescription is required), but may only be dispensed by a pharmacist after an assessment of the patient's needs or the provision of patient education. Regulations detailing the establishments where drugs may be sold, who is authorized to dispense them, and whether a prescription is required vary considerably from country to country. ## Usage [edit] [...] [edit] In Canada, there are four drug schedules: Schedule 1: Requires a prescription for sale and is provided to the public by a licensed pharmacist. Schedule 2: Does not require a prescription but requires an assessment by a pharmacist prior to sale. These drugs are kept in an area of the pharmacy where there is no public access and may also be referred to as "behind-the-counter" drugs. Schedule 3: Does not require a prescription but must be kept in an area under the supervision of a pharmacist. These drugs are kept in an area of the retail outlet where self-selection is possible, but a pharmacist must be available to assist in the self-selection of medication if required. Unscheduled: Does not require a prescription and may be sold in any retail outlet.

  • Over-the-Counter (OTC) Medications - Drugs.com

    Skip to main content # 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. ## Search OTC drugs ## Popular OTC related searches Advil Claritin Differin Excedrin Migraine Gaviscon Imodium MiraLAX Motrin IB Orajel Pepcid AC Pepto-Bismol Prilosec OTC Robitussin Tums Tylenol Zyrtec ## More information about OTC products ### What is an Rx-to-OTC switch? [...] ### 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.

  • Over-the-Counter Medicines - MedlinePlus

    URL of this page: # Over-the-Counter Medicines Also called: Non-prescription drugs, OTC medicines On this page ### Basics Summary Start Here Diagnosis and Tests ### Learn More Related Issues Specifics ### See, Play and Learn No links available ### Research Statistics and Research Journal Articles ### Resources Find an Expert ### For You Teenagers Patient Handouts ## Summary Over-the-counter (OTC) medicines are drugs you can buy without a prescription. Some OTC medicines relieve aches, pains, and itches. Some prevent or cure diseases, like tooth decay and athlete's foot. Others help manage recurring problems, like migraines and allergies. [...] In the United States, the Food and Drug Administration decides whether a medicine is safe and effective enough to sell over-the-counter. This allows you to take a more active role in your health care. But you also need to be careful to avoid mistakes. Make sure to follow the instructions on the drug label. If you don't understand the instructions, ask your pharmacist or health care provider. Also keep in mind that that there are still risks to taking OTC medicines:

  • Over-the-Counter Medicines | National Institute on Drug Abuse (NIDA)

    # Over-the-Counter Medicines Image ©iStock.com/cgering Over-the-counter (OTC) medicines are those that can be sold directly to people without a prescription. OTC medicines treat a variety of illnesses and their symptoms, including pain, coughs and colds, diarrhea, constipation, acne, and others. Some OTC medicines have active ingredients with the potential for misuse at higher-than-recommended dosages. Learn about the health effects of OTC medicines Dextromethorphan (DMX) and Loperamide and read the DrugFacts on Over-the-Counter Medicines. ## Looking for Treatment? Use the SAMHSA Treatment Locator or call 1-800-662-HELP (4357). ## More on this Topic DrugFacts ### Over-the-Counter Medicines DrugFacts | En español Infographic ### Monitoring the Future 2021 Survey Results

  • [PDF] Over-the-Counter Drugs and Cough/Cold Preparations - Medi-Cal Rx

    ml Magnesium Hydroxide Suspension, oral 400 mg/5 ml ml Polyethylene glycol 3350 Powder 238 gm 510 gm gm gm Sennosides Syrup 8.8 mg/5 ml ml Tablets 8.6 mg ea Sennosides / Docusate Sodium Tablets or Capsules 8.6 mg-50 mg ea Medi-Cal Rx Contract Drugs List – Over-the-Counter Drugs and Cough/Cold Preparations 14 09/01/2025 Drug Name Dosage Strength/ Package Size Billing Unit UM Type Code I Gastro-Intestinal Drugs: Laxatives Simethicone Chewable tablets 80 mg ea Drops, suspension 40 mg/0.6 ml ml Sodium Phosphate, Mono Dibasic Enema ml Hormones: Contraceptives Drug Name Dosage Strength/ Package Size Billing Unit UM Type Code I Hormones: Contraceptives Levonorgestrel Tablets 1.5 mg ea QL Restricted to a maximum quantity of one tablet per dispensing with a maximum of six dispensings in any [...] Contract Drugs List – Over-the-Counter Drugs and Cough/Cold Preparations 30 09/01/2025 Drug Name Dosage Strength/ Package Size Billing Unit UM Type Code I Topical, Local, and Oral Preparations: Dermatological Preparations Neomycin/Bacitracin/ Polymyxin B Ointment 3.5-400-5k gm Ointment pack 3.5-400-5k ea Neomycin/Bacitracin/ Pramoxine Cream 3.5-10k-10 gm Permethrin Cream rinse 1 % 59 ml ml Polymyxin b sulfate and Bacitracin Zinc Ointment 10,000U-500U/gm gm Pyrethrins, Piperonyl Butoxide, Petroleum Distillate Liquid 60 ml 120 ml ml ml Tolnaftate Cream 1 % gm Topical and Local Preparations: Vaginal Preparations Drug Name Dosage Strength/ Package Size Billing Unit UM Type Code I Topical and Local Preparations: Vaginal Preparations Butoconazole Nitrate Vaginal cream (prefilled applicator) 2 % [...] 125 mcg (5000u) 250 mcg (10,000u) 1,250 mcg (50,000u) ea ea ea ea ea ea Medi-Cal Rx Contract Drugs List – Over-the-Counter Drugs and Cough/Cold Preparations 21 09/01/2025 Drug Name Dosage Strength/ Package Size Billing Unit UM Type Code I Metabolic Supplements: Vitamins Vitamin E (Dl, tocopheryl acetate) Capsules 90 mg (200u) 180 mg (400u) 450 mg (1000u) ea ea ea Vitamins-mineral Capsules Combination product, prenatal ea Tablets ea Tablets, chewable Nonprescription only ea Miscellaneous: Antihistamine and Decongestant Combinations Drug Name Dosage Strength/ Package Size Billing Unit UM Type Code I Miscellaneous: Antihistamine and Decongestant Combinations Brompheniramine/ Phenylephrine/ Dextromethorphan Liquid 1-2.5-5 mg/5 ml ml AL Restricted to individuals 2 years of age and older.