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Prescription Drugs or Over-the-Counter (OTC) Drugs?

A drug is a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

  • Do not require a doctor’s prescription
  • Can be purchased off-the-shelf in stores or online
  • Regulated by FDA through OTC Drug Monographs

OTC drug monographs cover acceptable ingredients, doses, formulations, and labeling. Monographs are continually updated, with additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance.

Sales of hand sanitizer in the U.S. spiked by 1,400% due to the coronavirus (COVID-19).


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.

Lowest fees available here. At this time, no Government fee is required. Therefore, we can get you started as soon as possible.

Annual renewal of registration must occur between October 1 and December 31 of each year


■ Sunscreen
■ Antidandruff shampoo
■ Toothpaste containing fluoride
■ Antiperspirant deodorant
■ Cold and cough products
Hand sanitizers

Because there are over 300,000 marketed OTC drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, instead of individual drug products.