FDA Orajel Warning: Orajel Dangerous for Children Under 2

The active ingredient in Orajel is benzocaine, which the FDA has recently warned can induce a potentially fatal side effect whereby the blood carries significantly lower amounts of oxygen. This condition, known as methemoglobinemia, can in rare cases cause death or brain injury and damage to the body tissues.

Orajel products do not currently contain warnings of methemoglobinemia, which the FDA stated as a grave cause for concern since consumers, parents and caregivers are in most likelihood not aware of this potential side effect and as such very unlikely to be monitoring for the possible side effect. Methemoglobinemia induced by benzocaine use may require treatment with medications and/or admission to a hospital. The FDA recommends that anyone experiencing pale, gray or blue colored skin lips and/or nail beds, shortness of breath, fatigue, confusion, headache, lightheadedness or rapid heartbeat after taking a medication with benzocaine such as Orajel immediately call 911. Benzocaine-induced methemoglobinemia may occur after the first application or even after using the medication multiple times without incident.

Liquid and gel over the counter medications containing benzocaine and referenced in the FDA Benzocaine Warning include the following Anbesol products:Baby Orajel, Orajel Maximum Strenth, Orajel Medicated Toothache, Orajel Mouth Sore, Orajel PM, Orajel Ultra Mouth Sore and Orajel Denture Plus.