FDA's 2018 benzocaine action: nothing for teething, nothing under 2, and a warning on every oral product that stays

What it says#

On May 22, 2018 the FDA announced that over-the-counter oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed, asked the companies selling them to stop, and said it would initiate regulatory action to remove them if the companies did not comply. At the same time it asked the makers of every other OTC oral benzocaine product to add new warnings. The Drug Safety Communication dated the next day, May 23, 2018, states the rule plainly: OTC oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years, and should be used in adults and children 2 and older only if the label carries the warnings. The products at issue are gels, sprays, ointments, solutions and lozenges sold under brand names the FDA lists, Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, and as store brands and generics.

The label changes the FDA asked for are three: a warning about methemoglobinemia; contraindications, which the FDA calls its strongest warnings, directing parents and caregivers not to use the product for teething and not to use it in children under 2; and revised directions saying the same. The FDA also required the manufacturers of all approved prescription local anesthetics to standardize the methemoglobinemia warning in their prescribing information, and gave them 30 days to respond to its letter. The prescription products it lists are articaine, bupivacaine, chloroprocaine, lidocaine, mepivacaine, prilocaine, ropivacaine and tetracaine.

Methemoglobinemia is the reason. The communication describes it as a condition in which the amount of oxygen carried through the blood is greatly reduced; it can be life-threatening and result in death. Signs can appear within minutes to one to two hours after benzocaine is used, after a first use or after prior uses: pale, gray or blue skin, lips and nail beds; shortness of breath; fatigue; confusion; headache; lightheadedness; and a fast heart rate. Anyone with these signs should receive medical attention immediately. People with asthma, bronchitis or emphysema, heart disease, the elderly and smokers are at greater risk of complications, as are people with certain inborn deficiencies the communication names, including glucose-6-phosphate dehydrogenase deficiency; nitrites and nitrates in medications, food and water add to the methemoglobin benzocaine forms. For clinicians it adds that methemoglobinemia after a benzocaine spray is not dose-related and has followed a single spray, that a standard two-wavelength pulse oximeter can give unreliable oxygen saturation readings in this condition and an FDA-cleared multiple-wavelength co-oximeter should be used to measure it, and that resuscitation equipment and medications, including methylene blue, should be readily available where local anesthetics are used in procedures.

The evidence the FDA cites is a case count. It estimates more than 400 cases of benzocaine-associated methemoglobinemia reported to the agency or published since 1971, and says there are likely more it does not know about. Its review of 119 cases reported or published in the eight and a half years from February 2009 to October 2017 found most were serious and required treatment; 22 occurred in patients younger than 18 and 11 of those in children younger than 2; four patients died, including one infant. The FDA had communicated about the risk in 2006, 2011 and 2014 and, in its words, continued to receive cases after the 2014 communication. A laboratory comparison it ran found benzocaine generated much more methemoglobin than lidocaine in a red blood cell model.

What the FDA recommends instead is not a drug. For teething it points parents and caregivers to the American Academy of Pediatrics: gently rub or massage the child's gums with a finger, or give a firm rubber teething ring, not a frozen one. Topical pain relievers rubbed on the gums are not useful, the communication says, because they wash out of the baby's mouth within minutes, and the FDA repeats its earlier caution against certain homeopathic teething tablets. For adults with mouth pain it suggests a dilute salt water rinse and OTC pain relievers, and refers to the American Dental Association's advice on mouth sores. Where an OTC benzocaine product is used by someone 2 or older, the FDA's advice is to use the smallest amount that relieves the pain, not more than four times a day, and to watch for the signs above.

Who it applies to#

Parents and caregivers of infants and toddlers first: the under-2 line is absolute, and the teething products the office used to be asked about are the products the FDA asked to have withdrawn. Adults and children 2 and older who use an OTC benzocaine gel or lozenge for a sore throat, a canker sore or an irritated gum are covered by the warnings and the four-times-a-day advice.

Dentists sit on both sides of it. Hurricaine and Topex, brands familiar from the operatory, are on the FDA's list of OTC oral benzocaine products, and the communication notes that benzocaine sprays are not FDA-approved to numb the mucous membranes of the mouth and throat or to suppress the gag reflex during procedures. The injectable anesthetics in every dental cabinet, articaine, lidocaine, mepivacaine, prilocaine and bupivacaine among them, now carry the standardized methemoglobinemia warning, and the FDA asks health care professionals to warn patients of the possibility of methemoglobinemia and its signs when recommending or prescribing a local anesthetic. What the action is not is a ban on benzocaine or a restriction on a dentist's professional use of topical anesthetic in patients 2 and older; it is a labeling and marketing action for the OTC products and a labeling requirement for the prescription ones.

What changed#

The FDA had warned about benzocaine and methemoglobinemia three times before, in a 2006 public health advisory on sprays, in two Drug Safety Communications on April 7, 2011 covering gels and liquids on the gums and sprays in procedures, and in 2014, when it permitted manufacturers of oral benzocaine products to add a methemoglobinemia warning and, separately, told parents not to use lidocaine for teething. Those were warnings and permissions. The 2018 action was an instruction: stop selling the teething products, put the contraindication on everything else, and standardize the prescription class warning, with regulatory action promised if companies did not comply.

Since then the FDA has kept the advice and retired the documents. Its consumer update on teething, marked current as of June 26, 2024, still says topical products containing benzocaine or lidocaine offer little to no benefit and carry serious risks for teething pain, and adds a warning about teething jewelry such as amber necklaces, which the FDA links to reports of strangulation and choking. The 2018 news release, the Drug Safety Communication and the benzocaine safety information page have been removed from fda.gov, so this entry links to archived copies.

Where the source is#

The May 22, 2018 news release and the May 23, 2018 Drug Safety Communication were published on fda.gov, and fda.gov no longer serves either page or the benzocaine safety information page that indexed the 2006 to 2018 history; the links here open Internet Archive copies, the news release as captured in January 2025 and the other two as captured in December 2019. The FDA's consumer update on soothing teething pain is still live and repeats the advice. The American Academy of Pediatrics teething page the FDA cites is on HealthyChildren.org, and adverse events are reported through MedWatch. All of it is public and free to copy.