Over-the-Counter Drugs — An Introduction

OTC - An Introduction

OTC or over-the-counter drugs, also known as nonprescription medicines, are those medicines that can be used by general public safely and effectively just by following the directions on the label and/or as directed by a health care provider. These are often available on the shelves of pharmacies and non-pharmacy outlets like convenience marts, supermarkets, hypermarkets and grocery stores, so as to make them easily accessible for patients.

OTC ingredients and labels are reviewed and regulated by the U.S. Food and Drug Administration’s (FDA) Division of Drug Information (CDER). The Office of Drug Evaluation IV (ODE IV) has three divisions, namely:

  • The Division of Nonprescription Drug Products (DNDP)
  • The Division of Medical Imaging Products (DMIP)
  • The Division of Pediatric and Maternal Health (DPMH)

The DNDP regulates all the OTC medicines, and makes sure that their benefits surpass their risks. Therefore, these drugs are properly labeled, and can be used safely without medical supervision. There are more than 80 classes of OTC drugs, including more than 100,000 OTC drug products along with 800 active ingredients that are available without prescription.

Each class of drug has an OTC drug monograph, which contains acceptable ingredients, formulation, labeling and doses. New products that conform to an existing OTC drug monograph can be marketed without further review from the FDA. Drugs that do not conform to existing OTC monograph are required to get OTCapproval from the FDA through the New Drug Approval (NDA) system.


Besides, there is another class of OTC drugs, which is the restricted class of OTC drugs and includes emergency contraception, pseudoephedrine and some Schedule V controlled substances. These are kept behind the pharmacy counters and are only dispensed by the pharmacist after proper identification, age verification and patient education. Cholesterol, asthma, blood pressure, birth control medications and some other drugs are being considered by the U.S. FDA to be included in the restricted class of OTC drugs. This Rx-to-OTC switch ruling is at present under review.

Moreover, there is an educational program, Medicines in My Home (MIMH), which is an interactive multimedia program aimed at teaching how to choose OTC products to the consumers from adolescence through adulthood. Presentations, resources and print materials are available in different ‘rooms’ of the program that can be used online or downloaded by teachers, students and adults.

Each OTC medicine carries an OTC medicine label, which is like a brochure that introduces a user to an easily understandable Drugs Facts label. The brochure contains the importance of reading and using the label. Below is the list of different sections that are available on the brochure:

  • Active ingredients present in the medicine
  • Uses of the medicines
  • Warnings
  • Inactive ingredients
  • Purpose
  • Directions
  • Expiration Date
  • Lot or Batch Number
  • Name and address of manufacturer, packer, or distributor
  • Net quantity of contents
  • What to do in case of overdose
  • Information on how to store the medicine and other necessary information

It should be noted that dietary supplements that are regulated as food products do not carry the Drugs Facts label, but the Supplement Facts panel.
Some of the indications for which OTC drugs are available are:

  • Pain medications like NSAIDs: Acetaminophen, naproxen, ibuprofen
  • Fever reducers (antipyretics): Acetaminophen, ibuprofen
  • Sunscreen
  • Cough medicines: Guaifenesin, menthol throat lozenges
  • Decongestants: Pseudoephedrine, phenylephrine
  • Sore throat medicines: Dyclonine, phenol, acetaminophen, naproxen
  • Allergies: Diphenhydramine, chlorpheniramine fexofenadine, fluticasone
  • Diarrhea: Loperamide
  • Anti-dandruff

Nevertheless, there are potential risks associated with OTC medicines like side effects, drug and food interactions, or harm occurring due to excessive dosing. Hence, patients are required to read the ‘Drug Facts’ labels that is found along with all OTC products. Older patients, pregnant women, parents of younger children and all other consumers should always consult with their pharmacists and other health care providers before taking any OTC product and must clear their doubts regarding drug usage.