Is Auralgan (antipyrine and benzocaine) available in the United States?

Auralgan Availability in the United States

Auralgan (antipyrine and benzocaine otic solution) is not currently available in the United States. 1, 2

Current Status

• The FDA-approved formulation of antipyrine and benzocaine otic solution exists as a drug entity, but the branded product "Auralgan" and its generic equivalents are not available for purchase in the U.S. market 1, 2

• The drug label describes the formulation as containing antipyrine 54 mg and benzocaine 14 mg per mL in anhydrous glycerin with oxyquinoline sulfate as a preservative 3

Historical Context and Safety Concerns

• Auralgan was previously used as an over-the-counter otic analgesic for ear pain, particularly in children with acute otitis media 4

• Animal studies demonstrated significant ototoxicity when the drug contacted the middle ear through tympanic membrane perforations, including:

  • 30-50 dB hearing threshold shifts across all frequencies tested 5
  • Hair cell damage and stria vascularis injury with perilymphatic bleeding 5
  • Facial nerve paralysis in 80% of experimental animals 5
  • Dose-dependent cytotoxicity to cultured auditory cells 5

• Benzocaine carries risk of methemoglobinemia, with at least one reported infant death associated with overdosing of benzocaine-containing ear drops (methemoglobin level 36%) 6

Clinical Implications

• If a patient presents requesting Auralgan specifically, they should be counseled that the product is unavailable and alternative analgesics should be offered 1, 2

• For otalgia management, systemic analgesics (acetaminophen, ibuprofen) remain the standard of care without the ototoxicity risks associated with topical benzocaine products 4

• Any benzocaine-containing otic preparation should never be used when tympanic membrane perforation is present or suspected due to documented ototoxicity 5