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Are regulated by FDA through OTC Drug Monographs




Over-the-counter drugs are substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

These products

Do not require a doctor’s prescription

Can be purchased off-the-shelf in stores or online

Are regulated by FDA through OTC Drug Monographs



Antidandruff shampoo

Toothpaste containing fluoride

Antiperspirant deodorant

Cold and cough products

Hand sanitizers

OTC medicines provide affordable treatment options for both consumers and the U.S. healthcare system, with $146 billion in annual savings.

Revenue in the OTC Pharmaceuticals market amounts to $28.29 billion in 2023, with expected annual growth of 4.88% (2023-2027). The global OTC Drugs market is projected to grow to $233.6 billion in 2028.

In the past 30 years, the FDA has converted more than 700 prescription drug (Rx) products to OTC status, and on average, U.S. households spend about $338 per year on OTC products.

U.S. consumers make 26 trips a year to purchase OTC products. They only visit doctors, on average, three times a year. While there are approximately 54,000 pharmacies in the United States, there are more than 750,000 retail outlets that sell OTC products.


Sun exposure can cause sunburn, skin aging (such as skin spots, wrinkles, or “leathery skin”), eye damage, and skin cancer (Melanoma), the most common of all cancers.

The percentage of people who develop melanoma has more than doubled in the past 30 years, in the United States.

  • Ten percent of all people with melanoma have a family history of melanoma.
  • Non-Hispanic whites have the highest incident rate of melanoma with 28 cases per 100,000 people.
  • 7 per 100,000 in American Indians/Alaska Natives.
  • 5 per 100,000 in Hispanics.
  • 1 per 100,000 in non-Hispanic blacks and Asians/Pacific Islanders populations.

In 2023, it is estimated that:

  • There will be 186,680 cases of melanoma diagnosed, with 89,070 noninvasive cases (in situ) and 97,610 invasive cases. Of the invasive cases,
    • 58,120 cases will occur in men.
    • 39,490 cases will occur in women.
  • There will be 7,990 deaths from the disease.
    • 5,420 will be men.
    • 2,570 will be women.

FDA recommends use of broad spectrum sunscreen with sun protection factor (SPF) values of 15 or higher, even on cloudy days.

OTC sunscreen monograph establishes the conditions under which the FDA permits these products to be marketed without approved new drug applications, because they are generally recognized as safe and effective (GRASE), and not misbranded.

Two ingredients – zinc oxide and titanium dioxide – are GRASE for use in sunscreens. However, two ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens due to safety issues.

Products that combine sunscreens with insect repellents are not generally recognized as safe and effective (GRASE).

Pain Relievers and Fever Reducers (Internal Analgesics)

When you’re in pain, finding relief fast is top priority. However, if your pain lasts longer than ten days, it is important to reach out to your doctor or other healthcare professional.

OTC internal analgesics include the following active ingredients: acetaminophen, aspirin, ibuprofen, ketoprofen, and naproxen sodium.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are medicines used to temporarily treat minor to moderate pain and inflammation related to everything from arthritis, muscle aches, backaches, headaches, toothaches, sprains, strains, and menstrual cramps. They can also be used to reduce flu or common cold fevers and body aches.

NSAIDs are one of two major types of oral over-the-counter (OTC) pain relievers, the other being acetaminophen. Acetaminophen is in more than 600 over-the-counter (OTC) and prescription (Rx) medicines.

According to the FDA, unintentional overdoses represent a very low portion of serious adverse events. The overwhelming majority of fatalities related to acetaminophen overdose (83 percent for Rx and 84 percent for OTCs) are intentional suicides.


An OTC Monograph is a “rule book” for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, route of administration, labeling, and testing under which an OTC drug is generally recognized as safe and effective (GRASE).


Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of an otc drug product for commercial distribution is required to register with FDA.

Products that do not conform to an FDA Monograph require a New Drug Application (NDA).

We expect you to provide

  • Full company name, complete physical address
  • Company DUNS Number
  • Product FDA compliant label, active and inactive ingredients.
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These new fees are additional and required. User Fees are paid to the U.S. Treasury.

Manufacturers of hand sanitizers and alcohol wipes are no longer exempt.

Monograph Drug Facility (MDF) Facility Fee

Contract Manufacturing Organization (CMO) Facility Fee