Unapproved Over-the-Counter (OTC)
Drugs Still Marketed?

FDA has been reviewing the safety and effectiveness of marketed OTC drugs for many years. The OTC Drug Review has been a massive project evaluating nearly 1,000 active ingredients used in the estimated 300,000 marketed OTC drug products. Most of these drugs have been used for decades and have never been reviewed under the criteria set forth in the law. Those ingredients found acceptable appear in OTC drug monographs; for example, aluminum hydroxide is included in the OTC antacid monograph. Those ingredients found unacceptable cannot be shipped in interstate commerce after the effective date of the regulation. Most manufacturers reformulate their products, but in some cases no ingredients are found acceptable and the entire OTC category is removed, for example, OTC smoking cessation products.

This orderly process has sometimes caused some confusion in the marketplace. While the regulations prevent further interstate shipment of unacceptable ingredients and products after the effective date, FDA does not ordinarily call for removal of products already marketed. Hence, drug manufacturers need not recall products that have not been included in the monographs. In some cases, products may linger in the marketplace until supplies are exhausted. This decision by FDA is primarily based upon the lack of available resources for the agency to conduct an effective program for removal of the products already in the marketplace. In most cases, other programs are considered to be of higher priority. The vast majority of OTC ingredients that have to be removed are found to be ineffective and pose little safety risk. In view of these actions, FDA wants to inform the general public, including health professionals, of the status of the ingredients and products found unacceptable. The following summary list highlights agency actions.

Anticholinergics in cough-cold products

Includes atropine sulfate, belladonna alkaloids, etc. to "relieve excessive secretions of the nose and eyes."

Antifungal diaper rash products

Antifungals should be used only under a doctor's supervision.

Antifungal nail products

Includes camphorated metacresol, chloroxylenol, nystatin, etc.

Aphrodisiacs

Includes cantharides, ginseng, yohimbine, etc.

Boil treatments

Includes ichthammol, juniper tar, calomel, etc.

Digestive aids

Includes cellulase, garlic, ox bile extract, pancreatin, etc.

Exocrine pancreatic insufficiency drug products

Hair growers and hair loss prevention remedies

Includes cantharides, ginseng, yohimbine, etc.

Ingrown toenail relief

Includes chlorbutanol, chloroxylenol, sodium sulfide, etc.

Nailbiting or thumbsucking deterrents

Includes denatonium benzoate and sucrose octaacetate.

Ophthalmic anti-infectives

Includes yellow mercuric oxide, and boric acid for eyelid infections.

Oral treatment of fever blisters and cold sores

Includes lysine and Lactobacillus acidophilus.

Oral wound healing agents

Includes allantoin and carbamide peroxide in anhydrous glycerin for "minor oral injury."

Products for oral use as insect repellents

Thiamine hydrochloride (vitamin B₁) has been used.

Products to relieve the symptoms of benign prostatic hypertrophy

Includes amino acids "to relieve symptoms of urinary urgency and frequency," etc.

Products marketed as daytime sedatives

Includes antihistamines, bromides, etc. for claims such as "simple nervous tension, helps you relax."

Products to treat and/or prevent nocturnal leg muscle cramps

Includes quinine sulfate.

Products for the treatment of hyperphosphatemia/hypophosphatemia

Not amenable to self-diagnosis and self-treatment.

Products to prevent swimmer's ear

Smoking deterrents

Includes silver acetate, lobelia alkaloids, ginger, etc.

Stomach acidifiers

Includes betaine hydrochloride, diluted hydrochloric acid, and pepsin to treat achlorhydria and hypochlorhydria.

Theophylline-containing products to treat symptoms of asthma

People with asthma require individualized dosing by a doctor.

Topical hormone products

Includes estrogens, progestins, androgens, etc. for claims such as "removing wrinkles."

INGREDIENTS FOUND UNACCEPTABLE NOT INCLUDED ABOVE:

Sweet spirits of nitre

Benefits insignificant in view of risks.

Camphorated oil drug products

Often mistaken for castor oil, resulting in a large number of accidental ingestions.