The United States' federal Food and Drug Administration's monograph on oral antiseptic drug products reviewed the data regarding CPC and made this conclusion: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).
[10]The National Library of Medicine Toxicology Data Network (TOXNET) reviewed the range of toxicity of CPC and stated "Significant toxicity is rare after exposure to low concentration products that are typically available in the home.
[3] In combination with chlorhexidine and zinc lactate, CPC has been found to be effective in treating halitosis.
[15] Crest stated that because of the low incidence of staining, there was no need to label Pro-Health mouthwash as a potential tooth stainer.
[16] However, after numerous complaints[17] and a federal class-action lawsuit,[6] which was later dismissed,[18] the mouthwash now contains a label warning consumers of its potential to stain teeth.
[19] There is in-vitro evidence that cetylpyridinium chloride interferes with mitochondrial function at levels "that may be relevant to human exposures."