Scroll Top
ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States

Over-the-Counter (OTC) Drugs

Over-the-Counter (OTC) Drugs?

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

Unlike a prescription drug, an over-the-counter (OTC) drug

Does 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.

Current OTC Monographs List

Anorectal Drug Products

Antacid Products

Antidiarrheal Drug Products

Antiemetic Drug Products

Anthelmintic Drug Products

Antiperspirant Drug Products

Cholecystokinetic Drug Products

Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products

Corn and Callus Remover Drug Products

Deodorant Drug Products

Drug Products Containing Certain Active Ingredients

Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis

Ingrown Toenail Relief Drug Products

Internal Analgesic, Antipyretic, and Antirheumatic Drug Products

Nighttime Sleep Aid Drug Products

Ophthalmic Drug Products

Oral Healthcare Drug Products

Orally Administered Menstrual Drug Products

Pediculicide Drug Products

Poison Treatment Drug Products

Sunscreen Drug Products

Skin Protectant Drug Products

Stimulant Drug Products

Topical Acne Drug Products

Topical Otic Drug Products

Wart Remover Drug Products

Products conforming to a monograph may be marketed without further FDA clearance.


There are more than 80 therapeutic categories of OTC drugs, ranging from acne drug products to weight control drug products.

  • Sunscreen
  • Antidandruff shampoo
  • Toothpaste containing fluoride
  • Antiperspirant deodorant
  • Cold and cough products
  • Laxative
  • Skin protectant
  • Vaginal contraceptive
  • Weight control
  • Hand sanitizers

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

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


Are considered illegal, among other acts:

Introduction or delivery for introduction into interstate commerce of any drug that is adulterated or misbranded.

Adulteration or misbranding of any drug in interstate commerce.

Receipt in interstate commerce of any drug that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.


Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of an OTC drug product for commercial distribution is required to register with the U.S. Food and Drug Administration.

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


Expect to pay these annual Service Fees, when seeking and requesting the assistance of ITB HOLDINGS LLC.

A foreign company or registrant must provide the name, address, and phone number of its U.S. Agent such as ITB HOLDINGS LLC.

The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Establishment Identification (FEI) Number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.

Clear Filters
Item added to cart View Cart Checkout



Annual Service Fee.

Company Registration.

Product Listing.

U.S. Agent Service.

User Fee is not included.

We expect you to provide:

  • Full company name, complete physical address
  • Company DUNS Number
  • Product FDA compliant label, active and inactive ingredients.

The following fees are effective under the Over-The-Counter Monograph Drug User Fee Program (OMUFA).

User Fees are paid to the U.S. Treasury.

These new User Fees also apply to establishments manufacturing, processing hand sanitizers and alcohol wipes.

▪ Monograph Drug Facility (MDF) Facility Fee:
$34,166 (FY 2024).
$26,153 (FY 2023).

▪ Contract Manufacturing Organization (CMO) Facility Fee:
$22,777 (FY 2024).
$17,435 (FY 2023).

OMUFA fees are expected to increase substantially, each fiscal year.


If a facility does not pay the annual facility fee within 20 calendar days of the due date, the FDA will place such company on a publicly available arrears list.

Furthermore, all OTC monograph drug products produced at that facility (or containing an ingredient manufactured at that facility) will be deemed misbranded under section 502(ff) of the FD&C Act.

Avoid the detention of your products by the U.S. Customs or the U.S. FDA.