Is Orajel Safe for Babies? Here's What the Experts Say

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 regular Orajel to soothe the gum pain just yet. The Food and Drug Administration (FDA) warns against the use of Orajel in children under 2 years of age. That said, Baby Orajel is considered safe because it's free of benzocaine and belladonna, the primary ingredients in Orajel for adults. But is it effective?

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

What to Know About Orajel's Ingredients

Orajel is an oral pain reliever that's designed to disinfect the mouth and numb the pain associated with toothaches, gum irritation, and dentures in adults. 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? The short answer: benzocaine.

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 Those products have been replaced by a non-medicated product called Orajel Baby, which the company says is safe for babies over 3 months old.

Why Benzocaine Is Problematic

In 2018, the FDA issued a safety announcement advising consumers of the potential danger of using products containing benzocaine in children under 2 years of age.

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. 

Though children under 2 are at high risk for developing methemoglobinemia, it can also affect other vulnerable populations such as older adults, people with breathing problems (like emphysema), and people with heart conditions.

How Common Is Methemoglobinemia?

The FDA reported that it had been monitoring cases of methemoglobinemia for several years. By the time the administration released its 2018 safety announcement, it was estimated that about 400 cases had been reported since the early 1970s.

Several cases occurred between 2009 and 2017 that the FDA considered serious. Of those 119 cases studied, the FDA found that:

• 22 cases occurred in children under 18 years old
• 11 of those cases occurred in children under 2 years old
• 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 in children outweigh the benefits. Since it’s a topical treatment applied to the mouth, it rubs off easily without providing much relief. The FDA asked that all products for children containing benzocaine be removed from the market.

What To Know About Homeopathic Teething 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, the FDA doesn't recommend the use of teething tablets. 

How To Relieve Teething Pain

Parents and caregivers should avoid using products with potentially harmful ingredients like benzocaine for their infants, and Orajel Baby promises to be free from those active ingredients. But while Orajel Baby products are considered safe for babies over 3 months, the FDA and AAP say that they aren't the most effective remedy for teething pain as they wash out of a baby's mouth within minutes.

So what are you supposed to do about the pain associated with teething? No parent likes to see their baby in pain, but no parent wants to use unsafe or ineffective 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, including:

• 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, English muffins, or teething biscuits (for older babies) can 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 a comfort object that can make them feel better 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 a health care provider about the appropriate dosage of pain relievers like infant Tylenol (acetaminophen) or Motrin (ibuprofen) for your baby, and reserve it for those days or nights when nothing else will do.