Cetylpyridinium Chloride (CPC) in Over-the-Counter (OTC) Drugs
The DailyMed database of the U.S. Food and Drugs Administration (FDA) lists at least 125 OTC oral healthcare products containing CPC (as of September 2012). These OTC products include oral wash, oral rinse, as well as ingestable products (e.g. CPC lozenges). In addition, cough syrups containing CPC are also available as OTC medications (e.g. Kilcof Cough Mixture).
The mission of the Center for Drug Evaluation and Research (CDER) at the FDA is to ensure that drugs marketed in the United States are safe and effective. The CDER has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs. The FDA publishes “recipe books” or “monographs” about specific OTC drugs. Each OTC drug monograph covers acceptable ingredients, doses, formulations, labeling, and, in some cases, testing parameters.
The FDA monograph on oral antiseptic drug products reviewed the data regarding CPC and concluded the following (pg. 6094): “The agency believes that the information contained in its adverse reaction files, 30 years of safe marketing of an OTC mouthwash containing cetylpyridinium chloride (NDA 14- 598), and the safety data evaluated by the Oral Cavity Panel are sufficient to conclude that 0.025 to 0.1 percent cetylpyridinium chloride is safe as an OTC oral antiseptic when labeled for short-term use (not to exceed 7 days).”
In addition, the National Library of Medicine Toxicology Data Network (TOXNET) reviewed the range of toxicity of CPC, and stated that, “Significant toxicity is rare after exposure to low concentration products that are typically available in the home.”
The fatal dose in humans ingesting cationic detergents has been estimated to be 1 to 3 g. Therefore, a person using a typical oral ingestible product that provides 0.25 mg CPC per dose will need to take 4000 doses at one time to feel any toxic effects.
A review of clinical studies on cetylpyridinium chloride (CTC), published in the International Journal on Dental Hygiene, found that mouthwashes containing CPC "provide a small but significant additional benefit when compared with toothbrushing only or toothbrushing followed by a placebo rinse" in reducing plaque and gingivitis-inflammation.
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