What is the schedule classification for Diphenhydramine and its salts for topical use in concentrations of 2% or less when sold in larger packages?

Diphenhydramine and its salts for topical use in concentrations of 2% or less, when sold in larger packages, are classified as Schedule 3 substances. This classification reflects that these products are considered to have a relatively low risk of misuse and can be sold without a prescription, but may still be subject to certain controls, such as being available in pharmacies or under the supervision of a pharmacist.

Schedule 3 substances are accessible for self-selection by consumers, which supports easier access for those needing over-the-counter relief from allergies, skin irritations, or similar issues. This designation allows for consumer safety while ensuring that there is some level of professional oversight during the purchasing process.

Other classifications like Schedule 2 or Schedule 4 do not appropriately apply in this case because they typically pertain to substances with higher risks associated with their use and are subject to greater restrictions. Unscheduled products, while they may be available more broadly, do not specifically encompass the unique aspects of topical diphenhydramine use as highlighted in this situation. Thus, Schedule 3 is the most fitting classification, providing a balance between accessibility and proper use oversight.