What cold medicines are they pulling off the shelf? A guide for consumers

October 8, 2025 •

4 min read

In a significant move impacting over-the-counter (OTC) remedies, an FDA advisory panel unanimously voted in September 2023 that oral phenylephrine, a common ingredient in many cold and allergy medicines, is ineffective for treating nasal congestion. This has led to the question: what cold medicines are they pulling off the shelf? The answer is tied directly to this ingredient and the voluntary actions of some retailers.

Quick Summary

The FDA has determined that oral phenylephrine is ineffective, prompting the agency to propose removing it from the Generally Recognized as Safe and Effective list. Retailers like CVS have already begun pulling products containing only oral phenylephrine, leading to reformulations by manufacturers and consumer confusion about effective alternatives.

Key Points

Oral phenylephrine is ineffective: The FDA has concluded that oral phenylephrine does not effectively relieve nasal congestion because the body metabolizes most of the drug before it can work.
FDA has proposed removal: The FDA has proposed removing oral phenylephrine from the list of ingredients generally recognized as safe and effective (GRASE), kicking off a process to pull these products from shelves.
CVS and other retailers acted early: Following the FDA advisory panel's vote, some major pharmacies, including CVS, voluntarily pulled certain products containing oral phenylephrine as the sole decongestant ingredient.
Affected products include major brands: Numerous products across popular brands like Sudafed PE, DayQuil, Mucinex, and store-brand equivalents contain oral phenylephrine.
Effective alternatives exist: Proven effective alternatives include behind-the-counter pseudoephedrine, nasal spray decongestants like oxymetazoline (Afrin), nasal steroid sprays like Flonase, and saline sprays or rinses.
Safety is not the issue: The FDA has stated that the action is based on a lack of efficacy, not safety concerns with oral phenylephrine at recommended doses.
Check the Drug Facts label: Consumers must read product labels carefully, as many brands offer both phenylephrine (PE) and pseudoephedrine (D) versions.
Combination products are still useful for other symptoms: If a product contains oral phenylephrine plus other ingredients for pain or fever, those other ingredients will still be effective, but the decongestant part of the medication will not work.

FDA Declares Common Decongestant Ineffective

In a landmark decision, a panel of advisors to the U.S. Food and Drug Administration (FDA) concluded that oral phenylephrine, a widely used decongestant, is not effective when taken in pill or liquid form. This ingredient is found in hundreds of over-the-counter (OTC) cold and allergy medications and is often marketed as a “non-drowsy” decongestant option. The issue is not one of safety—the FDA has stressed that oral phenylephrine is not a safety risk at recommended doses—but of efficacy. Scientific review found that the human body metabolizes most of the oral dose before it can reach the nasal passages and cause a decongestant effect.

Following the advisory panel's unanimous vote, the FDA initiated a public, multi-step process to formally remove oral phenylephrine from the list of ingredients "Generally Recognized as Safe and Effective" (GRASE). While the process is lengthy and includes a public comment period, it signals a major shift that will require manufacturers to either remove or reformulate products containing the ingredient.

Which Cold Medicines are Being Affected?

With the FDA's proposal underway, consumers are seeing changes on pharmacy shelves. In a proactive move, retailers like CVS have already started pulling products where oral phenylephrine is the sole active decongestant. This affects numerous brand-name and store-brand products. Consumers should always check the Drug Facts label to identify the active ingredients in their medication.

Commonly affected products and brands include:

Sudafed PE
Some DayQuil products
Some Mucinex products
Some Benadryl products
Some Theraflu products
Store-brand equivalents (e.g., CVS Health, Equate, Walgreens)

It is important to note that many cold and flu products are combination medicines containing multiple active ingredients. For example, a medication might contain phenylephrine for congestion relief, but also acetaminophen for pain and fever. In these cases, the other ingredients will continue to provide relief for their intended symptoms. However, the decongestant effect from the oral phenylephrine component is still considered ineffective.

Alternatives to Oral Phenylephrine for Congestion Relief

For those seeking effective relief from nasal congestion, several options remain available. These alternatives have been shown to work and include both over-the-counter medications and non-medication remedies. Consumers can easily find these effective alternatives on pharmacy shelves and behind the counter.

Alternatives include:

Oral Pseudoephedrine: This is the effective decongestant that oral phenylephrine was meant to replace after pseudoephedrine was moved behind the counter due to its use in methamphetamine production. It is still available without a prescription, but you must ask for it at the pharmacy counter and show a photo ID.
Nasal Sprays (Topical Decongestants): Both phenylephrine nasal spray and oxymetazoline (brand name Afrin) nasal spray deliver the medication directly to the nasal passages, where it is absorbed effectively. It is crucial to use these sprays only for a maximum of three days to avoid a condition known as rebound congestion, where overuse makes congestion worse.
Nasal Corticosteroid Sprays: Products like Flonase (fluticasone) are primarily used for allergy-related congestion but can also be effective for general nasal stuffiness when used daily.
Saline Nasal Sprays and Irrigation: Saline sprays and neti pots offer a gentle, non-medicated way to moisturize and flush out nasal passages, providing safe and immediate relief.

Comparison of Oral Decongestants


Feature	Oral Phenylephrine (e.g., Sudafed PE)	Oral Pseudoephedrine (e.g., Sudafed)
Effectiveness for Congestion	Not proven effective in oral form based on modern clinical studies.	Proven effective for relieving nasal congestion.
Availability	Still on shelves (voluntarily removed by some stores), but slated for FDA removal.	Available from behind the pharmacy counter; requires ID.
Side Effects	Generally safe but ineffective. Possible side effects include restlessness, trouble sleeping, and increased blood pressure.	Potential side effects include increased blood pressure and heart rate, restlessness, and insomnia.
Regulation	Subject to future FDA final order removal.	Controlled substance, regulated by federal law.

How to Navigate the Changes

With shelves in flux and product formulations changing, here is how consumers can make informed choices:

Read the Label: The most important step is to read the “Active Ingredients” section on the Drug Facts label. Do not rely on brand names alone, as many now offer a "PE" version containing phenylephrine and a behind-the-counter version with pseudoephedrine.
Consult a Pharmacist: Your pharmacist is an excellent resource for navigating OTC cold and flu options. They can help you identify effective products based on your specific symptoms and health conditions, such as high blood pressure.
Consider Multi-Symptom Products Carefully: If you choose a multi-symptom product containing oral phenylephrine, be aware that you are effectively purchasing a decongestant that does not work. The other ingredients will still address pain, fever, or cough, but you will need an alternative for congestion relief.

Conclusion

The FDA's proposed removal of oral phenylephrine marks a significant moment in consumer pharmacology, refocusing attention on drug efficacy. While this ingredient is not unsafe, it is demonstrably ineffective for treating nasal congestion when taken orally. For consumers, this change means being more vigilant when purchasing cold and allergy medications. By checking labels, consulting pharmacists, and considering proven alternatives like pseudoephedrine, effective nasal sprays, or simple saline solutions, you can ensure you are getting the relief you need from congestion without relying on an ingredient that doesn't work. The process of removing oral phenylephrine from OTC products will continue, and consumers should expect to see continued market changes as manufacturers and retailers adapt. The shift is ultimately aimed at providing consumers with access to medications that are not only safe, but truly effective.

For additional information on selecting the right cold medicine for your symptoms, consult the resources available at the U.S. National Library of Medicine.

Frequently Asked Questions

The FDA initiated a review after clinical pharmacists petitioned the agency, citing concerns and data suggesting oral phenylephrine was ineffective. Modern studies conducted in controlled allergen chambers showed no significant difference between oral phenylephrine and a placebo in relieving nasal congestion.

No. The FDA's concern is with the drug's lack of effectiveness, not its safety. At current doses, oral phenylephrine is not considered a safety risk, but it also won't provide the decongestant relief you are seeking.

To identify if your medication contains this ingredient, you must check the 'Active Ingredients' section on the Drug Facts label. Products containing oral phenylephrine are often labeled with "PE" in the brand name, but you should always verify by reading the label.

Oral phenylephrine is ineffective as a decongestant when swallowed. Pseudoephedrine, available behind the pharmacy counter, has been proven effective for nasal congestion relief. Phenylephrine is easily accessible on store shelves, while pseudoephedrine is regulated.

Effective alternatives include oral pseudoephedrine (from behind the counter), nasal sprays containing oxymetazoline (Afrin) or phenylephrine, nasal corticosteroid sprays (Flonase), or using saline nasal sprays and irrigation.

The FDA's finding of ineffectiveness applies only to oral formulations (pills and liquids). Nasal spray versions of phenylephrine, which deliver the drug directly to the nasal passages, are still considered effective for short-term use.

There is no need to discard your medication for safety reasons. However, if you are relying on it for nasal congestion relief, you should not expect it to be effective and may consider purchasing an effective alternative.