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National Drug Schedules: Final Recommendations for FDC of Acetaminophen and Ibuprofen

National Drug Schedule

The interim recommendations made by the National Drug Scheduling Advisory Committee (NDSAC) on December 7, 2025, that:

  • Acetaminophen and ibuprofen, when sold in oral, fixed-dose combinations, in package sizes containing either more than 20,000 mg of acetaminophen or more than 6,000 mg of ibuprofen remain in Schedule II, and
  • Acetaminophen and ibuprofen, when sold in oral, fixed-dose combinations, in package sizes containing 20,000 mg or less of acetaminophen and 6,000 mg or less of ibuprofen remain in Schedule III

were finalized effective January 27, 2026. Final approval of the interim recommendations was made by NAPRA’s Board of Directors. In this case, NAPRA did not receive any comments during the 30-day consultation period.

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