USP Quality Review

No. 54, Issued 5/96

OTC NAMES: AN INVITATION TO ERR?

Manufacturers invest considerable resources in creating brand name recognition for their products in an effort to inspire consumer trust and brand loyalty. With over-the-counter (OTC) drug products, consumers also may associate a certain therapeutic outcome with a product's brand name. For example, the brand names Chlor-Trimeton® and Benadryl®, and Mylanta® and Maalox® may suggest a definite therapeutic outcome to most consumers.

Brand name extension is the reuse of a well-known, successful brand name to introduce a new product that may contain an active ingredient different from the active ingredient in the original brand name product. The proliferation of these brand name extensions not only causes confusion but also presents a danger to the average patient/consumer.

Appropriate OTC product selection and use, previously possible by relying on a well-known brand name, apparently has become elusive. Consumers can become confused by similarly named but therapeutically distinct products and may not use them appropriately. At the same time, it appears that health care practitioners have become annoyed with the similarity of some OTC product names, packaging, and labeling. Product labeling is, at times, not explicit enough to emphasize the different indications and active ingredients of products with the same brand name.

The USP Practitioners' Reporting NetworkSM (USP PRNSM) has received reports on the use of brand name extension products where confusion about ingredients, strength, and concentration has led to product mix-ups, incorrect dosing, and contraindicated use, as in the following reports.