What is the active ingredient in Maximum Strength Orajel (benzocaine)?

Maximum Strength Orajel Active Ingredient

Maximum Strength Orajel contains benzocaine 20% (w/w) as its active ingredient. 1

Product Composition

• The FDA-approved formulation contains 20% benzocaine by weight, which is the standard concentration for maximum strength topical oral anesthetic products 1
• This 20% concentration has been demonstrated effective for intraoral topical anesthesia when applied for appropriate durations 2

Clinical Characteristics of Benzocaine 20%

Onset and Duration:

• Benzocaine typically begins working within 5 minutes of application 3
• The anesthetic effect lasts approximately 15-45 minutes 3
• In toothache studies, benzocaine 20% gel showed median onset of 8.3 minutes with duration exceeding 115 minutes 4

Efficacy Profile:

• Benzocaine 20% is effective as a single agent for topical oral anesthesia 2
• In controlled trials for toothache pain, 20% benzocaine gel achieved an 86.7% responder rate compared to 46.7% for placebo 4
• The product provides rapid onset of pain relief with relatively long duration of action 4

Important Safety Considerations

Methemoglobinemia Risk:

• Benzocaine carries a risk of methemoglobinemia, a potentially serious complication that requires rapid identification and treatment 3, 5
• This risk is particularly relevant when occlusion is used or large surface areas are treated 3

FDA Approval Status:

• While benzocaine otic solutions are available, they are not FDA-approved for safety, effectiveness, or quality 3
• Topical anesthetic drops should not be used if tympanic membrane integrity is uncertain 3

Clinical Limitations:

• Benzocaine should not mask progression of underlying disease while suppressing pain 3
• If prescribed for temporary pain relief, patients should be reexamined within 48 hours to ensure appropriate response to primary therapy 3