Over-the-counter medicine
Naproxen and pseudoephedrine First approved as Aleve-D Sinus & Cold
Naproxen and pseudoephedrine (Aleve-D Sinus & Cold) is an over-the-counter medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.244 per unit (All day sinus-cold-d 220-120 mg) in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the naproxen and pseudoephedrine FDA label on DailyMed (effective April 25, 2025, Cardinal Health 110, LLC. dba Leader); the NDA 21076 record on Drugs@FDA; every naproxen and pseudoephedrine label on DailyMed.
Highlights of the record
FDA label of April 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagetemporarily relieves these cold, sinus, and flu symptoms:
sinus pressure
minor body aches and pains
headache
nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
fever
Forms and strengths
- 120 mg / 220 mg
- 220 mg / 120 mg
Film-coated extended-release tablet; extended-release tablet; tablet; multilayer extended-release tablet.
On the market
- Earliest approval on file
- November 29, 1999 Aleve-D Sinus & Cold, Bayer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first March 17, 2004; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 10 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.244 per unit All day sinus-cold-d 220-120 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 20,510 through July 30, 2026
What is naproxen and pseudoephedrine used for?
From the label: indications and usagetemporarily relieves these cold, sinus, and flu symptoms:
sinus pressure
minor body aches and pains
headache
nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
fever
Conditions named in the indications of naproxen and pseudoephedrine's FDA labels, with every medicine labeled for each:
From other naproxen and pseudoephedrine labelsCough and cold: Uses temporarily relieves these cold, sinus, and flu symptoms:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug and alpha-Adrenergic Agonist.
Source: FDA drug label (Leader All Day Sinus and Cold D), ANDA076518 (Perrigo), as published by Cardinal Health 110, LLC. dba Leader, effective April 25, 2025 (SPL set 83f7cfbb-ab84-4594-ae7a-4a657385c8a7), via openFDA; the full label on DailyMed
Is there a generic for naproxen and pseudoephedrine (Aleve-D Sinus & Cold)?
The FDA approved the first generic naproxen and pseudoephedrine on March 17, 2004. 3 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 naproxen and pseudoephedrine from 10 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2004 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for naproxen and pseudoephedrine (Aleve-D Sinus & Cold)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.244 per unit (All day sinus-cold-d 220-120 mg), up 7% from $0.228 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- All day sinus-cold-d 220-120 mg (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| All day sinus-cold-d 220-120 mg | Generic | $0.244 per unit | n/a | +7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the naproxen and pseudoephedrine label say about other medicines?
The naproxen and pseudoephedrine 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 (Leader All Day Sinus and Cold D), ANDA076518 (Perrigo), as published by Cardinal Health 110, LLC. dba Leader, effective April 25, 2025 (SPL set 83f7cfbb-ab84-4594-ae7a-4a657385c8a7), via openFDA; the full label on DailyMed
What do FAERS reports show for naproxen and pseudoephedrine?
The FDA Adverse Event Reporting System holds 20,510 reports that list naproxen and pseudoephedrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,259 are coded as a death and 4,903 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 else is labeled for the same conditions as naproxen and pseudoephedrine?
16 other medicines are given the same way (oral) and in the same FDA class as naproxen and pseudoephedrine or labeled mainly for the same use (cough and cold), the same class first. Cough and cold lists all 31 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Cough and cold | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Acetaminophen and aspirin and caffeine | Cough and cold | 39 labelers | $0.0648 per unit 250-250-65 mg cplt | No current entry |
| Ibuprofen and phenylephrine | Cough and cold | 3 labelers | n/a | No current entry |
| Chlorpheniramine and ibuprofen and phenylephrine | Cough and cold | none listed | n/a | No current entry |
| Diphenhydramine | Cough and cold | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| Dextromethorphan and guaifenesin | Cough and cold | 61 labelers | $0.0207 per mL 200-20 mg/20 mL | No current entry |
| Guaifenesin | Cough and cold | 102 labelers | $0.284 per tablet 600 mg tablet | No current entry |
| Benzonatate | Cough and cold | 45 labelers | $0.0656 per capsule 100 mg capsule | No current entry |
Every medicine labeled for the same conditions as naproxen and pseudoephedrine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to naproxen and pseudoephedrine
- 16 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Naproxen and pseudoephedrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other