FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth.
"On April 7, 2011, the U.S. Food and Drug Administration (FDA) warned the public about the use of over-the-counter (OTC) products containing benzocaine, an ingredient used to reduce pain in the mouth and gums. Benzocaine use may cause a rare, but serious condition where the amount of oxygen that can be carried through the blood stream is greatly reduced. This condition is called methemoglobinemia. FDA is particularly concerned about the use of OTC benzocaine products in children for relief of pain from teething because of the serious outcomes, including death, that may be associated with methemoglobinemia, as well as the difficulty parents or consumers may have in recognizing the signs and symptoms of methemoglobinemia when using these products at home. Furthermore, symptoms of methemoglobinemia may not always be evident or attributed to the condition.
Parents and caregivers should not use OTC benzocaine products on children under two years of age, except under the advice and supervision of a healthcare professional. If benzocaine products are used, it should be used sparingly and only when needed, but not more than four times a day.
Below is some additional information about benzocaine, methemoglobinemia, and steps consumers can take if they have or recognize an adverse reaction after using an OTC product containing benzocaine."
List of OTC Benzocaine Products
Dent’s Maxi-Strength Toothache
Orajel Medicated Toothache
Orajel Mouth Sore
Orajel Multi-Action Cold Sore
Anbesol Cold Sore Therapy
Dry Socket Remedy
Orajel Ultra Mouth Sore
Anbesol Maximum Strength
Red Cross Canker Sore
Benzocaine Burn Spray
Rid-A-Pain Dental Drops
Boil Ease Maximum Strength
Kanka Soft Brush
Cepacol Sore Throat
Lanacane Maximum Strength
Orabase with Benzocaine
Walgreens Oral Anesthetic Paste
Orajel Denture Plus
Dent’s Extra Strength Toothache
Orajel Maximum Strength
Zilactin Toothache and Gum Pain
Here are some some: Questions & Answers: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth