Quick answers
- What is Aleve?
- Aleve is a brand name of Naproxen, Naproxen and pseudoephedrine, Diclofenac and Diphenhydramine and naproxen, an over-the-counter medicine. The FDA NDC Directory lists 30 Aleve products in 6 strengths and forms.
- Who makes Aleve?
- Bayer holds the FDA application for Aleve (NDA020204, approved January 11, 1994). 4 other companies (repackagers or distributors) also list Aleve products.
- Is there a generic or store brand of Aleve?
- Yes. The FDA NDC Directory lists 130 other products with the same active ingredients, strength and form as a Aleve product, 107 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has Aleve been recalled?
- No recall linked to Aleve products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Aleve is
Each Aleve 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.
Naproxen · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| naproxen sodium 220 mg capsule, liquid filled (oral) | Aleve Easy Open Arthritis Cap, Aleve liquid gels, Aleve | 34 products, 30 companies | DailyMed |
| naproxen sodium 220 mg tablet (oral) | Aleve, Aleve Headache Pain, Aleve Caplets, Aleve Back and Muscle Pain | 39 products, 28 companies | DailyMed |
| naproxen sodium 220 mg tablet, coated (oral) | Aleve Gelcaps | 43 products, 23 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Naproxen →
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 (oral) | Aleve-D Sinus and Headache, Aleve-D Sinus and Cold | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Naproxen and pseudoephedrine →
Diclofenac · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| diclofenac sodium 0.1% gel (topical) | Aleve Arthritis Pain Gel | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Diclofenac →
Diphenhydramine and naproxen · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| diphenhydramine hydrochloride 25 mg · naproxen sodium 220 mg tablet, film coated (oral) | Aleve PM | 14 products, 14 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Diphenhydramine and naproxen →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020204 | Bayer | January 11, 1994 | 23 |
| ANDA076518 | Perrigo | March 17, 2004 | 2 |
| NDA021920 | Bionpharma | February 17, 2006 | 2 |
| NDA205352 | Bayer Hlthcare | January 17, 2014 | 1 |
| ANDA211253 | Perrigo Pharma Intl | May 16, 2019 | 1 |
| ANDA214463 | Patheon Softgels | January 10, 2023 | 1 |
Companies that list Aleve
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Aleve products.
- Bayer HealthCare LLC.23 products
- Lil' Drug Store Products, Inc4 products
- R J General Corporation1 product
- Navajo Manufacturing Company Inc1 product
- Select Consumer Group1 product
Recalls
No recall linked to Aleve 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.