Over-the-counter medicine
Diphenhydramine and naproxen Brand names: Aleve; first approved as Aleve Pm
Diphenhydramine and naproxen (Aleve) is an over-the-counter medicine with an FDA approval on record since 2014. FDA's NDC Directory lists it from 17 generic labelers.
- Generic listed
- Over the counter
Check it at the source: the diphenhydramine and naproxen FDA label on DailyMed (effective December 4, 2025, Bayer HealthCare LLC.); the NDA 205352 record on Drugs@FDA; every diphenhydramine and naproxen label on DailyMed.
Highlights of the record
FDA label of December 4, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagefor relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
Forms and strengths
- 25 mg / 220 mg
- 220 mg / 25 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- January 17, 2014 Aleve Pm, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first October 23, 2018; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 18 of which 17 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 142,048 through July 30, 2026
What is diphenhydramine and naproxen used for?
From the label: indications and usagefor relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
FDA pharmacologic class: Histamine-1 Receptor Antagonist and Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Aleve PM), Bayer HealthCare LLC., effective December 4, 2025 (SPL set 82891458-ab0d-459a-8602-dcebd22c3010), via openFDA; the full label on DailyMed
Is there a generic for diphenhydramine and naproxen (Aleve)?
The FDA approved the first generic diphenhydramine and naproxen on October 23, 2018. 5 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists diphenhydramine and naproxen from 17 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2014 earliest approval on file
- 2018 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the diphenhydramine and naproxen label say about other medicines?
The diphenhydramine and naproxen label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | warnings | Warnings Allergy alert Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. |
Source: FDA drug label (Aleve PM), Bayer HealthCare LLC., effective December 4, 2025 (SPL set 82891458-ab0d-459a-8602-dcebd22c3010), via openFDA; the full label on DailyMed
What do FAERS reports show for diphenhydramine and naproxen?
The FDA Adverse Event Reporting System holds 142,048 reports that list diphenhydramine and naproxen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11,472 are coded as a death and 36,235 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antihistamines
- the pharmacologic class, with prices and generics
- Diphenhydramine and naproxen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other