Quick answers
- What is Theraflu?
- Theraflu is a brand name of Acetaminophen and dextromethorphan, Acetaminophen, diphenhydramine and phenylephrine, Acetaminophen, dextromethorphan and phenylephrine, Acetaminophen and diphenhydramine and Acetaminophen, chlorpheniramine and dextromethorphan, an over-the-counter medicine. The FDA NDC Directory lists 18 Theraflu products in 13 strengths and forms.
- Who makes Theraflu?
- Haleon US Holdings LLC lists 14 of the 18 Theraflu products in the FDA NDC Directory.
- Is there a generic or store brand of Theraflu?
- Yes. The FDA NDC Directory lists 22 other products with the same active ingredients, strength and form as a Theraflu product, 22 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has Theraflu been recalled?
- FDA enforcement reports list 1 recall of Theraflu products; the newest started June 18, 2013. A recall usually concerns specific lots, not every product.
What Theraflu is
Each Theraflu product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Acetaminophen and dextromethorphan · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 1000 mg · dextromethorphan hydrobromide 30 mg powder (oral) | Theraflu Flu Relief Max Strength Daytime | None listed | DailyMed |
| acetaminophen 1000 mg · dextromethorphan hydrobromide 30 mg powder, for solution (oral) | Theraflu Relief Max Strength Daytime | 3 products, 3 companies | DailyMed |
| acetaminophen 1000 mg/30 mL · dextromethorphan hydrobromide 30 mg/30 mL syrup (oral) | Theraflu Flu Relief Max Strength Daytime | None listed | DailyMed |
| acetaminophen 325 mg · dextromethorphan hydrobromide 10 mg tablet, chewable (oral) | Theraflu Severe Cold Relief Soft Chews | None listed | DailyMed |
| acetaminophen 500 mg · dextromethorphan hydrobromide 20 mg powder, for solution (oral) | Theraflu Severe Cold Relief Daytime | 1 product, 1 company | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen and dextromethorphan →
Acetaminophen, diphenhydramine and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 500 mg · diphenhydramine hydrochloride 25 mg · phenylephrine hydrochloride 10 mg powder (oral) | Theraflu Severe Cold relief Nighttime | None listed | DailyMed |
| acetaminophen 650 mg · diphenhydramine hydrochloride 25 mg · phenylephrine hydrochloride 10 mg powder, for solution (oral) | Theraflu Powerpods Nighttime Severe Cold | 10 products, 10 companies | DailyMed |
| acetaminophen 650 mg/237 mL · diphenhydramine hydrochloride 25 mg/237 mL · phenylephrine hydrochloride 10 mg/237 mL powder, for solution (oral) | Theraflu Severe Cold Relief Nighttime, Theraflu Nighttime Severe Cold and Cough | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, diphenhydramine and phenylephrine →
Acetaminophen, dextromethorphan and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 500 mg/237 mL · dextromethorphan hydrobromide 20 mg/237 mL · phenylephrine hydrochloride 10 mg/237 mL powder, for solution (oral) | THERAFLU Severe Cold Relief Daytime, Theraflu Multi-Symptom Severe Cold | None listed | DailyMed |
| acetaminophen 650 mg · dextromethorphan hydrobromide 20 mg · phenylephrine hydrochloride 10 mg powder, for solution (oral) | Theraflu PowerPods Daytime Severe Cold, Theraflu Daytime Severe Cold and Cough | 3 products, 3 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, dextromethorphan and phenylephrine →
Acetaminophen and diphenhydramine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 650 mg · diphenhydramine hydrochloride 25 mg powder, for solution (oral) | Theraflu Severe Cold Relief Nighttime | 3 products, 3 companies | DailyMed |
| acetaminophen 650 mg/30 mL · diphenhydramine hydrochloride 25 mg/30 mL syrup (oral) | Theraflu Severe Cold Relief Nighttime | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen and diphenhydramine →
Acetaminophen, chlorpheniramine and dextromethorphan · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 1000 mg · chlorpheniramine maleate 4 mg · dextromethorphan hydrobromide 30 mg powder, for solution (oral) | Theraflu Relief Max Strength Nighttime | 2 products, 2 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, chlorpheniramine and dextromethorphan →
FDA approval
Theraflu products are sold under an FDA over-the-counter monograph: rules that set the allowed active ingredients, strengths and label wording, so these products do not need an individual FDA approval.
Companies that list Theraflu
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Theraflu products.
- Haleon US Holdings LLC14 products
- CVS Pharmacy2 products
- Select Consumer Group1 product
- R J General Corporation1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 18, 2013 · Class II · Terminated · D-752-2014
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-count packets per carton — Novartis Consumer Health
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.