390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240
OTC DRUGS
OTC DRUG ESTABLISHMENT

Before you export any Over-the-Counter (OTC) drug product to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.

Is your company manufacturing, exporting, importing, distributing Hand Sanitizers, Wet Wipes, Fluoride Toothpaste, Antiperspirants, Dandruff Shampoos, Sunscreens?

OTC DRUG ESTABLISHMENT REGISTRATION

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)

U.S. Agent Service

■ Label Review

■ Label Design

Hand sanitizers and Sunscreens are some of more than 300,000 Over-the-Counter (OTC) drug products that are marketed in the U.S. without the need for FDA pre-approval.

OTC drug products are available to consumers without a doctor’s prescription.

WHAT IS AN OTC DRUG MONOGRAPH?

Monographs define the safety, effectiveness, and labeling of all active ingredients.

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.

Acne
Alcohol
Allergy
Analgesic, External
Analgesic, Internal
Anorectal
Antacid
Anthelmintic
Antibiotic, First Aid
Anticaries
Anticholinergic
Antidiarrheal
Antiemetic
Antiflatulent
Antifungal
Antihistamine
Antimalarial
Antimicrobial
Antiperspirant
Antipyretic
Antirheumatic
Antitussive
Aphrodisiac
Astringent
Benign Prostatic Hypertrophy
Boil Treatment
Bronchodilator
Camphorated Oil
Cholecystokinetic
Cold & Cough
Colloidal Silver
Callus Remover
Corn Remover
Dandruff
Daytime Sedative
Decongestant, Nasal
Dental Care
Deodorant
Diaper Rash
Digestive Aid
Drink Overindulgence
Exocrine Pancreatic Insufficiency
Expectorant
External Analgesic
Fever Blister
First Aid Antibiotic
Food Overindulgence
Hair Growth & Loss
Hormone
Hypophosphatemia
Hyperphosphatemia
Ingrown Toenail
Insect Bite & Sting
Insect Repellent
Internal Analgesic
Internal Deodorant
Laxative
Leg Muscle Cramps
Male Genital Desensitizers
Menstrual
Nailbiting
Nasal Decongestant
Nighttime Sleep Aid
Ophthalmic
Oral Health Care
Oral Wound Healing
Otic
Overindulgence, Food & Drink
Pancreatic Insufficiency
Pediatric
Pediculicide
Poison Oak/Ivy
Poison Treatment
Prostatic Hypertrophy
Psoriasis
Seborrheic Dermatitis
Sedative, Daytime
Skin Bleaching
Skin Protectant
Sleep Aid, Nighttime
Smoking Deterrent
Stimulant
Stomach Acidifier
Sunscreen
Sweet Spirits Of Nitre
Thumbsucking
Topical Analgesic
Vaginal Contraceptive
Vaginal Drug Products
Vitamins & Minerals
Wart Remover
Weight Control.

Government Fees

OTC Monographs are not subject to user fee, yet. That could change, soon.
(Over-the-Counter Monograph Drug User Fee Act – OMUFA).

FDA plans to publish a Federal Register Notice (FRN) to establish fees with respect to OTC monograph drug facilities and OMORs for FY 2021 (Fiscal Year 2021 – October 1, 2020 to September 30, 2021).

FDA will collect two types of user fees under OMUFA: Facility Fees and OTC Monograph Order Request (OMOR) fees from certain manufacturers of OTC monograph drugs.

Annual Registration Renewal

All Drug Establishments must renew their registration between October 1 and December 31, 2020.