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Phenylephrine, a widely available decongestant found in products like Sudafed PE, has been labeled ineffective by the FDA's advisory panel. Unlike the original Sudafed formula kept behind the counter, this over-the-counter option has failed to deliver results. The FDA is now preparing to withdraw it from store shelves, following last year's decisive ruling.
While these medications will stay on shelves temporarily, the FDA has issued a proposed order, with a public comment period ending on May 7, 2025. CBS News notes that manufacturers will then have time to either reformulate or discontinue their products.
Which cold medications contain the ineffective ingredient?
Phenylephrine, the ineffective ingredient, is commonly found in over-the-counter cold remedies such as Sudafed PE, Mucinex FastMax, and Dayquil, among others. (Below, you'll find a comprehensive list of brands and products, along with a guide to the best cold medicines here.)
Phenylephrine is intended to act as a decongestant, alleviating nasal and sinus congestion. It became widespread in cold medications after pseudoephedrine, an effective alternative, was restricted to pharmacy counters under a 2006 law. (Pseudoephedrine can be used to produce meth, hence the restrictions—though it remains available without a prescription. You simply need to request it and provide ID.) Even Sudafed, whose name derives from pseudoephedrine, introduced a reformulated version to stay on shelves. Phenylephrine is the "PE" in "Sudafed PE."
According to the FDA panel, phenylephrine is ineffective and always has been. Many consumers purchased Sudafed PE mistakenly, thinking it was the original Sudafed.
Phenylephrine isn’t exclusive to Sudafed PE. It’s the most widely used oral decongestant (available in pill or syrup form). Other over-the-counter medications containing phenylephrine include:
Tylenol Sinus & Headache, Tylenol Sinus Severe, Tylenol Cold & Flu, Tylenol Cold & Flu Severe, Tylenol Cold & Head Congestion Severe
Theraflu Severe Cold Relief, Theraflu ExpressMax, Theraflu Multi-Symptom Severe Cold
Mucinex FastMax, Mucinex NightShift, Mucinex SinusMax
Alka-Seltzer Plus Cold and Flu (both Day and Night formulas), Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz
DayQuil, NyQuil Severe Cold & Flu, Nyquil Severe Cold & Flu Honey, DayQuil Severe Cold & Flu Honey
While this isn’t an exhaustive list, if you’re thinking, 'That covers nearly every cold medicine claiming to relieve nasal congestion,' you’re correct. For an effective cold remedy, you’ll need to present your ID and purchase pseudoephedrine-based products.
What sets phenylephrine apart from pseudoephedrine?
Both are currently FDA-approved as over-the-counter decongestants. In short: pseudoephedrine is highly effective but comes with purchasing restrictions. Phenylephrine is more accessible but largely ineffective.
Pseudoephedrine, the key ingredient in original Sudafed, works by narrowing blood vessels, which helps reduce nasal congestion. It’s chemically related to ephedrine, a stimulant found in ephedra (ma huang), and shares similarities with methamphetamine, making it a controlled substance. Since 2006, federal law has mandated that pseudoephedrine be stored behind pharmacy counters, with purchase limits and records kept of buyers.
Phenylephrine is intended to constrict blood vessels and ease congestion, but research shows it degrades in the body, with minimal active ingredient reaching the nasal passages (unless used as a nasal spray). When pseudoephedrine sales were restricted, manufacturers turned to phenylephrine-based alternatives. Financially, this was a smart move, as many consumers, unaware of the superior Sudafed behind the counter, opt for Sudafed PE, mistakenly believing it to be equivalent. It is not.
How is it possible to sell a cold medication that doesn’t work?
This is a valid question that has puzzled doctors and researchers for years. For instance, a study published in the Annals of Pharmacotherapy titled 'Why Is Oral Phenylephrine on the Market Despite Clear Evidence of Its Ineffectiveness as a Decongestant?' highlights this issue.
In 2007, the FDA contemplated removing phenylephrine from the market but chose to allow its sale pending further research. One proposed solution was testing higher doses, but the FDA panel later deemed this unsafe due to potential risks like elevated blood pressure.
For those interested in the scientific reasoning behind phenylephrine’s ineffectiveness, the briefing document reviewed by the FDA panel provides detailed insights. It critiques earlier studies that claimed the drug’s efficacy and presents findings from placebo-controlled trials showing phenylephrine performs no better than a placebo.
The document also argues that consumers benefit from avoiding ineffective medications, which not only waste money but also carry potential side effects or allergic reactions, risks inherent to any drug.
What steps should I take if my preferred cold medication is removed from the market?
This change won’t happen immediately. The FDA is still gathering feedback and won’t take action until at least next year. (It’s aware that pharmaceutical companies will likely oppose the move.)
If you regularly purchase a product containing phenylephrine and it’s eventually withdrawn, you’ll face the same dilemma as everyone else: finding alternative decongestants or going without. As previously mentioned, the most effective options include pseudoephedrine (available behind the counter) for congestion, honey for coughs, and acetaminophen or ibuprofen for fever and body aches. (Avoid homeopathic cold remedies; they aren’t what they appear to be.)
That said, there are alternatives to pseudoephedrine for congestion relief. Antihistamines can be effective for allergy-related congestion. Saline nasal irrigation, such as using a neti pot, is also helpful. Phenylephrine nasal sprays remain effective and will stay available. Additionally, consulting your doctor or pharmacist can provide further guidance on other treatment options.
