Naproxen

In Canada, naproxen and its salts, including naproxen sodium, are listed on the federal Prescription Drug List for human use and are prescription drugs, except when sold for oral use with a daily dosage equivalent to 400 mg of naproxen base. Under the Food and Drug Regulations, listed products generally may be sold only on receipt of a verbal or written prescription, subject to the section C.01.043 exception. Health Canada's Drug Product Database lists APO-NAPROXEN 500 mg tablets as a marketed prescription product and ALEVE 220 mg naproxen sodium tablets as a marketed non-prescription product, consistently with the oral daily-dose exception. The listing took effect on 26 March 2015.

In the United States, naproxen's federal marketing status depends on the approved product, strength, formulation, dosage form, and application. FDA records classify Aleve 220 mg naproxen sodium oral tablets under NDA 020204 as over-the-counter; each tablet contains the equivalent of 200 mg naproxen. Naproxen 250 mg, 375 mg, and 500 mg oral tablets under ANDA 212517 are prescription products whose packages bear the designation ‘Rx Only’. Under 21 U.S.C. § 353(b), drugs limited by their approved applications to professional supervision may be dispensed only by prescription. These product approvals do not authorize consumer marketing of unapproved bulk naproxen or establish the status of every naproxen formulation.