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Pharmacist FAQs

Frequently Asked Questions for Pharmacists on Duke's Magic Mouthwash

Q: The Board office regularly receives questions on the formula for Duke's Magic Mouthwash. What is the formula?

A: Duke's Magic Mouthwash Formula:
1. Nystatin Suspension, 100,000 u/ml, 30 mL. or Nysatin Powder 3 Million Units
2. Hydrocortisone 60 mg.
3. Diphenhydramine HCL Syrup
q.s. ad. 240 ml.

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Q: What is the appropriate Beyond Use Date (BUD) for Magic Mouthwash?

A: The appropriate USP <795> BUD for Magic Mouthwash depends on whether it is compounded and dispensed as an oral formulation or as a mucosal formulation.

Oral Formulation.  USP <795> requires that water-containing oral formulations be assigned a BUD that is no longer than 14 days under refrigerated storage conditions.  The directions for an oral formulation of Magic Mouthwash would be “swish and swallow” or similar.

Mucosal Liquid Formulation.  USP <795> requires that water-containing topical, dermal, and mucosal liquid and semisolid formulations be assigned a BUD that is no longer than 30 days under room temperature storage.  The directions for a mucosal liquid formulation of Magic Mouthwash would be “swish and spit” or similar. 
If a pharmacy compounds one batch of Magic Mouthwash to fulfil all Magic Mouthwash prescriptions – whether the directions are “swish and spit” mucosal formulation or “swish and swallow” oral formulations –  the assigned BUD must be the stricter one:  no longer than 14 days under refrigerated storage.

USP <795> does allow for longer BUD for Magic Mouthwash if the pharmacy has independent stability testing information.

For Commercially Available compounding kits please follow the manufacturers BUD and storage recommendations.  Their stability testing information should be included with the kit. 

 

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