Safety Information on Benzocaine-Containing Products
Benzocaine is in many oral drug products currently used to relieve pain in the mouth and gums from a variety of conditions, or for numbing the throat or airway for medical procedures. Benzocaine oral drug products come in the form of gels, sprays, liquids, and lozenges. Benzocaine sprays are not FDA-approved to numb the mucous membranes of the mouth and throat, or to suppress the gag reflex during minor medical and surgical procedures.
Additionally, benzocaine is an active ingredient in non-oral over-the-counter (OTC) drug products, as well as prescription drug products used to treat other conditions, such as numbing pain on skin.
Benzocaine can cause a serious condition in which the amount of oxygen carried through the blood is greatly reduced. This condition, called methemoglobinemia, is life-threatening and can result in death. Therefore, the FDA is warning that OTC oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. We are also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug facts label. These products carry serious risks and provide little to no benefit for the treatment of oral pain including teething.
Due to the significant safety risk of methemoglobinemia, FDA notified makers of OTC benzocaine oral health products that they should stop marketing these products for treating teething in infants and children younger than 2 years. We have also urged manufacturers of OTC oral drug products containing benzocaine for adults and children 2 years and older to add to include a warning about methemoglobinemia, contraindications stating “do not use” in children under 2 years of age, and update directions for use stating “do not use” in children under 2 years of age on the drug facts label.
FDA is also requiring all prescription local anesthetics, such as lidocaine, to standardize warning information about methemoglobinemia in the prescribing information across this class of drug products.
- Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics (Drug Safety Communication, 5/23/18)
- FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit (FDA Press Release, 5/23/18)
- Example Drug Facts Label (PDF - 30KB) Please note the sample Drug Facts Labeling has been updated. The Allergy Alert warning was updated to be consistent with the OTC Oral Health Care Drug Products Tentative Final Monograph.
- Do Teething Babies Need Medicine on Their Gums? No (Consumer Update, 5/23/18)
- Teething Recommendations for Parents and Caregivers
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by American Academy of Pediatrics (10/2016)
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FDA urges consumers and health care professionals to report adverse reactions involving benzocaine or other medicines to the FDA’s MedWatch program.
FDA will continue to monitor the safety of benzocaine products and will take additional actions if needed.
- FDA permits manufacturers of oral health care benzocaine products to include a methemoglobinemia warning, FDA statement (2014)
- 2014 FDA Letter to Consumer Health Products Association
- FDA Drug Safety Communication: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning (2014)
- Risk of methemoglobinemia in the medicine cabinet -- Patients need to know about benzocaine (PDF - 510KB) Pharmacy Today article (1/2012) (used with permission from the American Pharmacists Association)
- FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth [ARCHIVED] (2011)
- FDA Drug Safety Communication: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures [ARCHIVED] (2011)
- Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia [ARCHIVED], MedWatch Alert (2011)
- FDA Drug Safety Podcast for Healthcare Professionals: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth [ARCHIVED] (2011)
- Comunicado de la FDA sobre la seguridad de los medicamentos: Informes sobre un efecto adverso raro pero grave y potencialmente fatal del uso de benzocaína en gel o líquido de venta libre que se aplica a las encías o la boca [ARCHIVED] (2011)
- Caution Required When Using Over-The-Counter Oral Pain Relievers (PDF - 883KB) Consumer article (2011)
- FDA's Information for Healthcare Professionals: Benzocaine Sprays (PDF - 616KB) (2011)
- Public Health Advisory: Benzocaine Sprays marketed under different names, including Hurricaine, Topex, and Cetacaine [ARCHIVED] (2006)
- Patient Safety News: Advisory on Benzocaine Sprays and Methemoglobinemia, FDA Patient Safety News (2003)
- Anesthetic Sprays and Methemoglobinemia, FDA Patient Safety News (2003)
- ISMP Medication Safety Alert: Benzocaine-containing topical sprays and methemoglobinemia, Institute for Safe Medication Practices (2002)
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