★★☆Single study — solid evidence, such as one good trial or a large observational dataset, but not replicated at the top tier.
The FDA proposed pulling oral phenylephrine in 2024; it's not final
The FDA proposed removing it as an over-the-counter decongestant in November 2024. In September 2026 the order was still only proposed, so products using it stay on sale.
What the study found
The FDA's 2024 proposal to drop oral phenylephrine is still not final
The FDA proposed in November 2024 to drop oral phenylephrine as an over-the-counter decongestant, as not effective; in September 2026 it was still only proposed. South Africa's regulator gave makers until November 2025 to prove it works. Until an order is final, shelves stay as they are.
The caveat · Status as of September 2026
The status is dated: it reflects the FDA's order page on 26 September 2026. The proposal concerns effectiveness, not safety. It covers phenylephrine taken by mouth, not nasal sprays.