Quick answers
- What is Sudafed Pe?
- Sudafed Pe is a brand name of Pseudoephedrine, Acetaminophen and phenylephrine, Phenylephrine, Dextromethorphan and phenylephrine, Naproxen and pseudoephedrine, Oxymetazoline, Ibuprofen and phenylephrine and Acetaminophen, guaifenesin and phenylephrine, an over-the-counter medicine. The FDA NDC Directory lists 14 Sudafed Pe products in 11 strengths and forms.
- Who makes Sudafed Pe?
- Kenvue Brands LLC lists 9 of the 14 Sudafed Pe products in the FDA NDC Directory.
- Is there a generic or store brand of Sudafed Pe?
- Yes. The FDA NDC Directory lists 137 other products with the same active ingredients, strength and form as a Sudafed Pe product, 137 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has Sudafed Pe been recalled?
- No recall linked to Sudafed Pe products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Sudafed Pe is
Each Sudafed Pe 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.
Pseudoephedrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| pseudoephedrine hydrochloride 120 mg tablet, film coated, extended release (oral) | Sudafed Sinus Congestion 12 Hour | 21 products, 17 companies | DailyMed |
| pseudoephedrine hydrochloride 15 mg/5 mL solution (oral) | Childrens Sudafed Nasal Decongestant | None listed | DailyMed |
| pseudoephedrine hydrochloride 30 mg tablet, film coated (oral) | SUDAFED Sinus Congestion | 33 products, 25 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Pseudoephedrine →
Acetaminophen and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 325 mg · phenylephrine hydrochloride 5 mg tablet, film coated (oral) | Sudafed PE Sinus Pressure Plus Pain, SUDAFED PE Pressure Plus Pain | 16 products, 15 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen and phenylephrine →
Phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| phenylephrine hydrochloride 10 mg tablet, film coated (oral) | Sudafed PE Sinus Congestion | 25 products, 19 companies | DailyMed |
| phenylephrine hydrochloride 2.5 mg/5 mL solution (oral) | Childrens Sudafed PE NASAL DECONGESTANT | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Phenylephrine →
Dextromethorphan and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| dextromethorphan hydrobromide 5 mg/5 mL · phenylephrine hydrochloride 2.5 mg/5 mL solution (oral) | Childrens SUDAFED PE Cold plus Cough | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Dextromethorphan and phenylephrine →
Naproxen and pseudoephedrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| naproxen sodium 220 mg · pseudoephedrine hydrochloride 120 mg tablet, multilayer, extended release (oral) | Sudafed Sinus 12 Hour Pressure plus Pain | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Naproxen and pseudoephedrine →
Oxymetazoline · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| oxymetazoline hydrochloride 50 mg/100 mL spray (nasal) | SUDAFED OM Sinus Severe Original | 8 products, 5 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Oxymetazoline →
Ibuprofen and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ibuprofen 200 mg · phenylephrine hydrochloride 10 mg tablet, film coated (oral) | Sudafed PE Head Congestion Plus Pain | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Ibuprofen and phenylephrine →
Acetaminophen, guaifenesin and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 325 mg · guaifenesin 200 mg · phenylephrine hydrochloride 5 mg tablet, film coated (oral) | SUDAFED PE Head Congestion Plus Mucus | 34 products, 18 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, guaifenesin and phenylephrine →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA075153 | L Perrigo Co | February 26, 1999 | 2 |
| ANDA076518 | Perrigo | March 17, 2004 | 1 |
| ANDA203200 | Perrigo R and D | July 3, 2014 | 1 |
Companies that list Sudafed Pe
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Sudafed Pe products.
- Kenvue Brands LLC12 products
- Sportpharm LLC1 product
- A-S Medication Solutions1 product
Recalls
No recall linked to Sudafed Pe products (by their NDC code or label) appears in the FDA enforcement reports.
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.