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I can help, but I don’t have real-time access to the Federal Register. I’m not seeing a known, widely referenced “final order” in 2025 or 2026 specifically about oral phenylephrine based on my latest data. If you’re looking for a precise FR citation, you’ll want to check the Federal Register site directly. How you can find it quickly - Go to federalregister.gov - Search terms: “phenylephrine” and filter for Rule Type or Final Rule/Final Order - Narrow the date range to 2025 and 2026 - Look for FDA as the agency and review the entries’ citations (FR Vol./No., Date, and CFR reference) - If you have a docket number or a link, paste it here and I’ll help interpret it What I can tell you in brief context - Oral phenylephrine is an OTC decongestant ingredient. For many years, the FDA has questioned its efficacy at typical OTC doses and discussed regulatory actions, but as of the last update I have, there wasn’t a finalized Federal Register rule removing its OTC status. - The status of OTC phenylephrine has involved ongoing regulatory reviews and potential rulemaking, but final actions (final orders) would be published in the FR with a CFR citation and an effective date. If you want, I can: - Help interpret any specific FR notice you find (dates, effective date, what products are affected, etc.) - Summarize the current evidence on the efficacy and safety of oral phenylephrine - Compare regulatory paths (OTC monograph vs. new drug approval) and what a final order would imply for manufacturers and consumers Would you like me to help you search for the exact FR entry now if you can share a link or a docket number?
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