Why Orajel May Be Unsafe for Your Teething Baby

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Your 8-month-old baby has been fussy and irritable, waking up more frequently during the night, and putting everything—and we mean everything—into their mouth. It doesn’t take a parenting expert to guess that they're probably teething—and those teensy white ridges poking through their gums only confirm your suspicions.

But don't reach for a tube of Orajel to soothe the gum pain just yet. The U.S. Food and Drug Administration (FDA) warns against the use of Orajel in children under two years of age.

Here’s the scoop on the latest research behind the Orajel advisory—and what you can do instead to alleviate your baby’s teething pain

About Orajel's Ingredients

Orajel is an oral pain reliever made from several different ingredients designed to disinfect the mouth and numb the pain associated with toothaches, gum irritation, and dentures. It’s sold in the form of medicated creams, gels, liquids, strips, and mouth rinses. 

Many of us likely grew up either having that stuff slathered on our own gums or watched our parents do it to our siblings. How could something that’s been used as a teething pain reliever for decades now be declared unsafe? 

What Is Benzocaine?

Benzocaine is the active—and controversial—ingredient in Orajel. It is a topical anesthetic that can be found in everything from sunburn creams to cough drops. It's used to relieve pain, itching, and irritation in the mouth and on the skin. Benzocaine has also been included as the active ingredient in products sold by Anbesol, Hurricaine, and Orabase.

Orajel markets products to adults and children. However, it no longer sells products containing benzocaine for babies and young children. Those products have been replaced by a non-medicated cooling gel that Orajel says is safe for babies over three months of age.

Why Benzocaine Is Problematic

On May 23, 2018, the FDA released a safety announcement advising consumers of the potential danger in using products containing benzocaine in children under two.

The risk associated with benzocaine relates to a condition called methemoglobinemia, where the amount of oxygen carried through the blood is reduced so much it can be potentially life-threatening or even fatal. 

About Methemoglobinemia

According to the FDA advisory, signs of reduced oxygen in the blood appear shortly after using benzocaine and may include:

  • Shortness of breath
  • Fatigue
  • Confusion
  • Discolored lips or skin
  • Headache
  • Dizziness.

Though children under two are at high risk for developing methemoglobinemia, it can also affect certain vulnerable populations of adults such as the elderly, those with breathing problems (like emphysema), and those with heart conditions.

How Common Is Methemoglobinemia?

The FDA reported that it had been monitoring cases of the condition for several years, releasing safety warnings in 2006, 2011, and 2014. By the time the administration released its May 2018 safety announcement, it was estimated that about 400 cases had been reported since the early 1970s.

Specifically, there were a number of cases in recent years—from 2009 to 2017—that the FDA considered to be serious. Of those 119 cases studied, the FDA found that:

  • 22 cases occurred in children under 18;
  • 11 of those cases occurred in children under two;
  • 4 patients died as a result of methemoglobinemia, one of whom was an infant.

Though those numbers are statistically low, the FDA stated that the risks of using benzocaine outweigh the benefits. Since it’s a topical treatment applied to the mouth, it rubs off quite easily without providing much relief. The FDA asked that all products for children containing benzocaine be removed from the market and no longer manufactured.

Though the FDA didn’t formally take action against pediatric benzocaine products until 2018, the American Academy of Pediatrics (AAP) took serious notice of the administration’s warnings in 2011. It released a statement in May of 2011 advising parents and caregivers to avoid using benzocaine for teething pain in children under two, citing the risk of methemoglobinemia.

Homeopathic Treatments

With the concerns over benzocaine circulating widely between 2011 and 2018, the market for “natural” or “organic” teething pain relievers grew. Many of these products come in tablet form and are marketed as safer alternatives. 

But the FDA has performed tests on the ingredients in these tablets over the last decade and warns that they often contain inconsistent and or unsafe levels of ingredients, including belladonna—a deadly nightshade plant that can be toxic in certain amounts. As a result, neither the FDA nor the AAP recommend the use of teething tablets. 

What to Use Instead 

To answer the question on the mind of every parent who’s ever had a teething baby: what are we supposed to do about the pain associated with teething? It’s keeping your baby up at night and leaving them cranky all day. No parent likes to see their baby in pain, but no parent wants to use unsafe products on their baby, either.

Thankfully, you don’t have to. There are plenty of pediatrician-approved ways to ease the pain of teething without putting your baby at risk for serious side effects. Here’s how:

  • Baby-safe teething toys. Offer your baby plenty of plastic, rubber, wooden, or cloth teething toys to chew, gnaw, and suck on. As long as the materials are safe (i.e. they’re made with food-grade materials and don’t contain any small or easily breakable pieces), this is one of the quickest and easiest ways to soothe a cranky, teething baby.
  • Anything cold. Frozen water-filled teethers, chilled washcloths, mesh feeders filled with frozen baby food, fruits or veggies, even frozen halves of bagels or English muffins (for older babies) all make great non-medicated options for sore gums.
  • Gum massage. The AAP suggests massaging your baby’s gums gently with clean fingers. (Think how good a shoulder rub feels after a long, stressful day at work—it’s kind of the same soothing sensation for your little one’s gums!)
  • Pacifiers. These won’t actually ease gum or tooth pain, but the sucking sensation can distract a baby from the discomfort in their mouth. Plus, for many babies, pacifiers are simply a comfort object that can make them feel better on days when teething is especially frustrating.

Lastly, if none of these options seem to provide enough relief, you can give your baby medication in the form of a liquid pain reliever. Ask your doctor about the appropriate dosage of infant Tylenol or Motrin, and reserve it for those days (or nights) when nothing else will do. 

A Word From Verywell

Even though it's tempting to rub some Orajel on your cranky baby's gums to alleviate teething pain, both the FDA and the AAP recommend trying other options. Always check with your child's pediatrician if you're unsure about the safety of any potential teething remedies, medicated or otherwise.

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  1. U.S. Food and 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. Updated May 23, 2018.

  2. Benzocaine products can cause rare, sometimes fatal conditionAAP News. 2011;32(5). doi:10.1542/aapnews.2011325-26a

  3. U.S. Food and Drug Administration. FDA confirms elevated levels of belladonna in certain homeopathic teething products. Updated March 28, 2018.

  4. American Academy of Pediatrics. Baby teething pain. Updated December 20, 2018.