Will oral phenylephrine — found in DayQuil, Theraflu and other popular decongestants — be pulled from pharmacy shelves? What the FDA is planning after finding the ingredient ineffective.

With cold and flu season about to kick into high gear, it’s time to restock our medicine cabinets. But you may want to reconsider buying one longtime favorite, which is still available at some stores.

On Nov. 7, the Food and Drug administration announced a proposal to remove oral phenylephrine — a decongestant found in products by brands including Sudafed PE, Vicks DayQuil and Theraflu — from the market. The proposal comes over a year after advisers to the FDA unanimously concluded that phenylephrine is not actually effective.

So why are you still seeing medications with phenylephrine on pharmacy store shelves? Yahoo Life spoke with the FDA and top pharmacies to get the latest on where things stand.

Here's a recap of what happened

In September 2023, an FDA advisory committee of 16 experts held a two-day meeting, which culminated with the announcement that oral phenylephrine is not effective, and works no better than a placebo pill at relieving congestion.

As Yahoo Life reported last year, when taken in oral form, phenylephrine is metabolized so quickly that the amount absorbed into the bloodstream ends up being less than 1% of what was originally ingested, which experts concluded is not enough to be effective.

It’s important to note that the FDA advisory committee didn’t review nasal sprays or drops containing phenylephrine, so the announcement didn’t affect those forms of medications. The panel also didn’t find any safety concerns about oral phenylephrine, so if you’ve taken it in the past, you don’t need to worry.

The advisory panel’s conclusion wasn’t a surprise to many experts in the field, who had been flagging efficacy concerns about phenylephrine for years.

Brigid Groves, the American Pharmacists Association (APhA) vice president of professional and regulatory affairs, tells Yahoo Life that the APhA had submitted comments in support of removing oral phenylephrine from nasal decongestant products before the advisory committee meeting began.

“Pharmacists are aware of the lack of efficacy of oral phenylephrine because they see it firsthand,” Groves says.

If phenylephrine doesn't work, why are you still seeing it on store shelves?

The FDA advisory committee’s decision last year was nonbinding — meaning the FDA itself makes the final call on whether oral phenylephrine is considered effective and whether it needs to be removed from the market.

Until then, Groves says it’s still up to individual pharmacies and businesses whether they want to continue selling oral phenylephrine products.

Last October, a few weeks after the FDA advisory committee’s conclusion, CVS Health announced that the pharmacy chain would be removing certain phenylephrine products from stores. In a statement to Yahoo Life, CVS confirmed that they have “removed oral decongestant products that contained phenylephrine as the only active ingredient from CVS Pharmacy stores … but continue to offer many other oral cough and cold products to meet consumer needs.”

When Yahoo Life asked rival pharmacy chain Walgreens if they have chosen to remove oral phenylephrine products from store shelves, a spokesperson said: “We work with our suppliers to follow FDA regulations and guidelines.”

Will phenylephrine ever disappear entirely? What are next steps?

As an FDA spokesperson explained to Yahoo Life in September, if the agency decides oral phenylephrine is no longer considered “generally recognized as safe and effective” (or GRASE) as an over-the-counter nasal decongestant, the agency initiates a proposal to have it removed from store shelves.

But this Nov. 7 proposal doesn't immediately take oral phenylephrine off the market. The public has six months to comment on the proposed order and to provide any additional data for the FDA to consider. Only after the FDA issues a final order will manufacturers be required to reformulate or remove over-the-counter oral phenylephrine products.

What should you use instead?

If you’re congested, there are plenty of effective alternatives to oral phenylephrine.

“There’s so many other products out there that really do work,” Dr. James Tracy, vice president of the American College of Allergy, Asthma and Immunology, previously told Yahoo Life. “Almost all the nasal sprays, like nasal antihistamine sprays, they all work and they are also over-the-counter, but they don’t say ‘decongestant.’”

In addition to steroid nasal sprays and antihistamine sprays, Tracy says phenylephrine is still considered effective in nasal spray form — though Tracy warns it can be “habit-forming” if used regularly.

The most common oral decongestant that experts recommend is pseudoephedrine, though you’ll likely need to ask a pharmacist for help accessing it behind the counter.

This article was originally published on Sept. 10, 2024 and has been updated.