Babies generally start teething at around 4 to 7 months of age.  During this time, your baby may seem irritable, have frequent crying episodes, drool, and want to chew on things. Teething is a normal part of growing for your baby. It may be tempting to give your baby something to help relieve the pain, but some remedies can be harmful to your baby’s health. One medication you should never give your baby is benzocaine.
On May 23, 2018, the Food and Drug Administration (FDA) released a warning that products containing benzocaine should not be used to treat teething pain in babies and children younger than 2 years of age. [2,3] Benzocaine provides very little, if any, benefit to teething babies and can cause a potentially deadly condition, called methemoglobinemia. Benzocaine is the active ingredient in many over-the-counter products, including Hurricaine, Baby Orajel, Orajel, Orabase, Anbesol, Chloraseptic, Topex, and Cepacol. These products are sold in different forms, such as ointments, gels, solutions, sprays, and lozenges. Since these products are available over-the-counter, many parents may be unaware of the risks that this medication poses to their children. If you have any products containing benzocaine in your medicine cabinet or elsewhere in your home, you should ensure that they are kept out of reach of children to avoid accidental ingestion. Older children and adults are also at risk for methemoglobinemia. Always ask your doctor before using any benzocaine product in children over the age of 2 years.
What is benzocaine?
Benzocaine is a medication that relieves pain on the area to which it is applied. It has traditionally been used in oral gels that are applied directly to the gums to numb pain from teething, tooth problems, or dental procedures. Benzocaine products are not effective at relieving teething pain because they get swallowed and washed out of the mouth within minutes of application.
What is methemoglobinemia?
Methemoglobinemia is a blood disorder that prevents red blood cells from providing oxygen to the tissues in your body.  This means that your organs cannot get enough oxygen. Over time, this can cause paleness, bluish colored skin, difficulty breathing, sleepiness, confusion, headache, fast heartbeat, lightheadedness, seizures, and eventually, death (if not treated immediately). [5,6] These symptoms can occur within minutes to hours after using benzocaine. If you notice any of these symptoms in your child after using a benzocaine product, you should contact 911 immediately.
The FDA has estimated that over 400 cases of benzocaine-associated methemoglobinemia have either been reported to the FDA or published in medical literature since 1971.  Between February 2009 and October 2017, 119 cases of benzocaine-associated methemoglobinemia were reported, and most of these cases required treatment. Of these cases, 22 occurred in children under the age of 18 years, and 11 of these 22 cases were in children under 2 years of age. Four of the 119 individuals died from methemoglobinemia, including one baby.
What is the FDA doing?
In addition to the recent warning statements, the FDA has sent letters to manufacturers of benzocaine products, requesting that they stop marketing oral over-the-counter products for the treatment of infants and children under 2 years of age.  If the companies do not comply with the request within a designated time frame, the FDA will remove these products from the market.
The FDA has suggested the following label changes for over-the-counter benzocaine products:
- Add a warning about the risk of methemoglobinemia
- Add the following items in the contraindication section:
Do not use
- for teething
- in infants and children under 2 years of age
- Add the following statement in the directions section: do not use in infants and children under 2 years of age
Since benzocaine products are available over-the-counter in your local pharmacy, these labeling changes can help alert parents to the dangers of benzocaine and prevent methemoglobinemia from occurring in young children.
How can I help relieve my baby’s teething pain?
If your baby is teething, the American Academy of Pediatrics recommends that you offer him or her a firm rubber teething ring or gently massage the gums. [1,2] Do not freeze the teething ring. Frozen teething rings become too hard for a baby’s soft gums. You can read more about the symptoms of teething here and ways to sooth a teething baby here.
What about homeopathic remedies?
Included in the warning released by the FDA in 2018, teething babies should not be treated with homeopathic remedies, such as teething tablets or gels. If you have any homeopathic teething tablets or gels in your home, they should be disposed of.  Homeopathic teething remedies can cause sleepiness, trouble breathing, skin flushing, muscle weakness, difficulty urinating, agitation, or constipation. Homeopathic remedies have not been approved or evaluated by the FDA.
Make sure not to use any benzocaine products on babies and children under the age of 2. Past this age, you should still use caution and ask your doctor before using a product containing benzocaine because it can cause a potentially dangerous condition known as methemoglobinemia.
- American Academy of Pediatrics. Teething: 4 to 7 Months.
- U.S. Food & Drug Administration. Do Teething Babies Need Medicine on Their Gums? No.
- U.S. Food & Drug Administration. 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.
- U.S. National Library of Medicine. Methemoglobinemia, beta-globin type.
- Lehr J, Masters A, Pollack B. Benzocaine-induced methemoglobinemia in the pediatric population.
- U.S. Food & Drug Administration. Benzocaine and Babies: Not a Good Mix.
- AAFP News Staff. OTC Benzocaine Teething Products Not Safe for Young Children.
- U.S. Food & Drug Administration. FDA warns against the use of homeopathic teething tablets and gels.