More than 700 products sold over the counter today use ingredients or dosage strengths available only by prescription 30 years ago. As a result, American medicine cabinets contain a growing choice of nonprescription medicines to treat an expanding range of ailments.
Monographs define the safety, effectiveness, and labeling of all active ingredients. Click here for OTC ingredient list – alphabetical by monograph.
A New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is required, when a product does not conform to a final monograph.
There are more than 80 therapeutic categories of OTC drugs, ranging from acne drug products to weight control drug products.
Antibiotic, First Aid
Benign Prostatic Hypertrophy
Cold & Cough
Exocrine Pancreatic Insufficiency
First Aid Antibiotic
Hair Growth & Loss
Insect Bite & Sting
Leg Muscle Cramps
Male Genital Desensitizers
Nighttime Sleep Aid
Oral Health Care
Oral Wound Healing
Overindulgence, Food & Drink
Sleep Aid, Nighttime
Sweet Spirits Of Nitre
Vaginal Drug Products
Vitamins & Minerals
Establishment owners and operators (registrants) upon first engaging in the manufacture, preparation, propagation, compounding, or processing of OTC drugs, (including human drugs, veterinary drugs, and biological drug products) must register their establishments and submit listing information for all drugs in commercial distribution.
Registrants are also required to submit registration information for their establishments on or before December 31 of each year.
Failure to register is a prohibited act. An OTC drug is misbranded if it is manufactured in an establishment not duly registered.
A foreign company or registrant must provide the name, address, and phone number of the foreign registrant’s 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.
The FDA recognizes the DUNS Number as an acceptable Unique Facility Identifier (UFI) for the purpose of registrations. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) Inc. DUNS numbers can be obtained or confirmed by visiting D&B’s website.
ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, importers, or distributors:
▪ OTC Drug Establishment Registration
▪ Drug Product Listing
▪ New Drug Application (NDA)
▪ Label Review
▪ Label Design
- Company Registration
- Product Listing
- U.S. Agent Service
FDA collects two types of user fees under Over-The-Counter Monograph Drug User Fee Program (OMUFA):
- Facility Fees
- OTC Monograph Order Request (OMOR) fees from certain manufacturers of OTC monograph drugs.
Monograph Drug Facility (MDF) Facility Fee: $26,153.
Contract Manufacturing Organization (CMO) Facility Fee: $17,435.
Manufacturers of hand sanitizers and alcohol wipes are no longer exempt.