GUIDE
No — not for babies under 2. The FDA has warned against benzocaine teething gels due to the risk of methemoglobinemia, a potentially fatal condition.
Orajel Baby was a go-to recommendation for years. Now the FDA says otherwise. Here is exactly what happened, what the risks are, and what to use instead.
In May 2018, the FDA issued a formal safety communication titled "Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain." The key points were unambiguous:
Benzocaine — the active ingredient in products like Orajel Baby, Anbesol, and generic equivalents — can cause methemoglobinemia, a serious condition in which the amount of oxygen carried through the bloodstream is greatly reduced. This condition can be life-threatening and has resulted in death.
The FDA recommended that benzocaine oral products should not be used in children under 2 years of age, except under the advice and supervision of a healthcare professional. The FDA also asked manufacturers to stop selling over-the-counter benzocaine products intended for teething pain in children under 2.
This was not a precautionary measure based on theoretical risk. The FDA based its warning on actual adverse event reports — cases of methemoglobinemia in children who had used benzocaine products, some of which required emergency medical treatment.
| Year | What Happened |
|---|---|
| 2006 | FDA first issues advisory about benzocaine and methemoglobinemia risk |
| 2011 | FDA updates warning, notes continued reports of methemoglobinemia cases in children |
| 2014 | FDA receives additional adverse event reports involving young children |
| 2018 | FDA issues formal safety communication: warns against benzocaine oral products for children under 2. Asks manufacturers to stop selling these products for teething. |
| 2018+ | Some manufacturers reformulate products to remove benzocaine. Some benzocaine-containing products remain available on store shelves. |
Methemoglobinemia is a blood disorder in which an abnormal form of hemoglobin (called methemoglobin) builds up in the blood. Normal hemoglobin carries oxygen from the lungs to the body's tissues. Methemoglobin cannot carry oxygen effectively, which means tissues throughout the body become oxygen-deprived.
In the context of benzocaine use, the mechanism is straightforward: benzocaine causes the conversion of normal hemoglobin to methemoglobin. In adults, the body can usually compensate for small amounts of methemoglobin. In infants, whose blood volume is small and whose compensatory mechanisms are immature, even a small amount of benzocaine can push methemoglobin levels to dangerous territory.
Symptoms of methemoglobinemia include:
Methemoglobinemia can occur within minutes to hours of benzocaine exposure. It can happen on the first use or after multiple uses. There is no "safe" dose for infants. Treatment requires emergency medical care, and severe cases may require methylene blue (an antidote) administered intravenously.
This is not a minor side effect to weigh against benefits. The risks are serious, and the benefits of topical benzocaine for teething are minimal (brief numbing that washes away with saliva). The risk-benefit calculation is clear.
| Product | Active Ingredient | Risk | FDA Status |
|---|---|---|---|
| Benzocaine gels (Orajel Baby, Anbesol, Baby Ora-Gel, generic equivalents) | Benzocaine | Methemoglobinemia — blood cannot carry oxygen. Can occur at any dose, even first use. Potentially fatal. | FDA warning (2018): do not use in children under 2 |
| Viscous lidocaine (prescription) | Lidocaine | Seizures, brain injury, cardiac problems. Infants are especially vulnerable to accidental overdose. | FDA warning: not for use in infants for teething |
| Homeopathic teething gels | Varies — may contain belladonna or other ingredients | Inconsistent ingredient levels. Belladonna is a toxic alkaloid. Adverse events reported. | FDA warnings (2016, 2017) |
These alternatives are recommended by the AAP and AAPD. They are safe, effective, and widely available.
Every baby responds differently to teething remedies. Tracking what helps in tinylog means you will not be experimenting from scratch with every new tooth.
The FDA warning is not optional guidance. Benzocaine teething gels are not safe for children under 2. This is a formal regulatory warning based on documented harm, not a suggestion. Do not use these products.
If a provider recommends benzocaine, ask questions. The FDA guidance is clear and relatively recent (2018). If a healthcare provider recommends a benzocaine product for your teething baby, it is appropriate to ask about the FDA warning and request an alternative.
Systemic pain relief is the preferred approach. Acetaminophen and ibuprofen (6+ months) are safer and more effective than any topical product. They provide consistent, hours-long pain relief without the risks of topical anesthetics.
Call your pediatrician if you have used benzocaine. If you used a benzocaine product before learning about the FDA warning and your baby seems fine, do not panic — most exposures do not cause methemoglobinemia. But discontinue use immediately and mention it at your next visit. If your baby shows symptoms like pale or blue skin after using a benzocaine product, seek emergency medical care.
If you have an old tube of Orajel Baby or any benzocaine-containing oral product, dispose of it. Even if it was recommended by a provider years ago, the FDA guidance has changed. Check the active ingredients on any oral product before using it on your baby. If it contains benzocaine or lidocaine, do not use it.
Beyond the safety concerns, benzocaine gels have a practical problem: they wash away. Your baby produces saliva constantly, and a topical gel applied to the gum is diluted and swallowed within minutes. This means the numbing effect is brief and inconsistent, and your baby ends up ingesting the product. Systemic pain relief (acetaminophen, ibuprofen) provides longer-lasting, more reliable pain management.
Some products marketed as 'natural' or 'benzocaine-free' teething gels contain herbal ingredients, essential oils, or homeopathic preparations. These are not regulated by the FDA for safety or efficacy in infants, and their ingredient levels may be inconsistent. 'Natural' does not mean 'safe for babies.'
Acetaminophen and ibuprofen are well-studied, well-dosed, and well-understood in infants. They provide reliable pain relief that lasts hours — not minutes. If your baby is in enough pain that you are considering a topical gel, they are in enough pain to benefit from a proper dose of infant acetaminophen or ibuprofen.
This guide is for informational purposes only and is not a substitute for professional medical advice. If your baby has a fever of 100.4°F (38°C) or higher, is refusing to eat, or seems unusually unwell, contact your pediatrician — these symptoms are not typical of teething alone.
