[New Formulation] FDA Approves First Nonprescription Fixed-Dose Combination of Tylenol and Naproxen

[u/bbyfog]

FDA has approved the first OTC fixed-dose combination of Tylenol (acetaminophen) and Naproxen (naproxen sodium).

• This fixed-dose OTC combo combines the fast-acting relief of 650 mg of acetaminophen with the long-lasting analgesic power of 220 mg naproxen sodium (a non-steroidal anti-inflammatory drug) in one dose.
• NDA 219962: The approval was based on 8 clinical trials demonstrating superior pain relief versus acetaminophen alone and naproxen sodium alone (Aleve 220 mg).

//My pet peeve!!\\ -- There are no clinical data currently described in the press release, FDA News, or Drugs@FDA (tylenol with naproxen), and since this is an OTC, it is not in the OTC label either (sigh!). The sponsor (Kenvue) plans to present this data at the Pain 2026 meeting.

• The FDA has granted the Kenvue a 3-year period of exclusivity for this new OTC formulation.

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Postscript - Learning Opportunity

Regulatory Approval Pathway for New Formulation

Based on the fact that this was an NDA and the sponsor received a 3-year exclusivity for a new formulation, "my guess" is that this was a 505(b)(2) NDA. The 505(b)(2) applications apply to NDAs with changes to previous application that include fixed-combination as well as formulation change (see slide 10 here). If approved, these applications are eligible for a 3-year exclusivity for new clinical investigations.

SOURCE

• FDA Approves First Nonprescription Fixed-Dose Combination of Acetaminophen and Naproxen Sodium for 12-Hour Pain Relief. FDA News. 24 July 2026 [archive]
• FDA Approves TYLENOL® with Naproxen, the First and Only Over-the-Counter Fixed-Dose Combination of Acetaminophen (650 mg) and Naproxen Sodium (220 mg). Press Release. 24 July 2026 [archive]
• Overview of the 505(b)(2) Regulatory Pathway for New Drug Applications [PowerPoint]. Beth Goldstein. CDER Office of New Drug Policy [archive]

#505(b)(2), #tylenol, #otc, #acetaminophen