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Naproxen

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain, inflammation and fever, including arthritis, tendonitis, bursitis, acute gout, menstrual cramps and everyday aches.

Brand names AleveAnaproxAnaprox DSEC-NaprosynFlanax +11 more
Drug class Nonsteroidal Anti-inflammatory Drug
Rx/OTC Forms 5
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 427 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 4, 2026 🚨Recall on record · 3
Naproxen at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Naproxen (Aleve) is a familiar NSAID (nonsteroidal anti-inflammatory drug) that blocks the COX-1 and COX-2 enzymes, lowering the prostaglandins that drive pain, swelling and fever; a standard choice for arthritis, tendonitis, acute gout, menstrual cramps and everyday aches, it has been sold over the counter and by prescription for decades and is available as a generic. Short courses are usually well tolerated, and heartburn, indigestion or an upset stomach are what people notice most. Its boxed warning covers serious, sometimes fatal heart attack, stroke and stomach bleeding, so use the lowest dose for the shortest time and get help fast for black stools or chest pain.

Clinical pearls

  • Aleve is naproxen, so never combine it with ibuprofen, another NSAID or pain-relief aspirin; it adds stomach risk, not relief.
  • If you take low-dose aspirin for your heart, naproxen can blunt that protection and is no substitute for it.
  • If you take a water pill, ACE inhibitor or ARB, naproxen can weaken their blood pressure effect and strain your kidneys.
  • Bleeding risk climbs in older adults and anyone with a past ulcer, and further with warfarin or an SSRI antidepressant.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Naproxen and other NSAIDs raise the risk of serious, sometimes fatal heart attack, stroke, and stomach or intestinal bleeding, ulcers and tears.

The heart risk can start early in treatment and may grow with longer use. Naproxen must not be used around coronary artery bypass graft (CABG) surgery. GI problems can occur at any time and without warning symptoms. Older adults and people with a past stomach ulcer or GI bleeding are at higher risk.

Read the full warning on DailyMed →
How you get itPrescription and over the counter
Comes asTablet, Capsule, Extended-release tablet +2
Earliest FDA record1994
Companies listing it with the FDA142
FDA label last updatedAug 23, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide — a plain-language walkthrough of Naproxen, written from its FDA label.

What Naproxen is used for

▾

Naproxen is used for pain, inflammation and fever. Uses differ by product.

  • Prescription naproxen and naproxen sodium tablets: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.
  • Prescription tablets: tendonitis, bursitis, acute gout, pain and primary dysmenorrhea.
  • Naproxen Oral Suspension: the same conditions as the prescription tablets.
  • Naproxen Sodium Controlled-Release Tablets: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis, acute gout, primary dysmenorrhea and mild to moderate pain.
  • Over-the-counter naproxen sodium products: temporary relief of minor aches and pains from headache, backache, muscle aches, toothache, menstrual cramps, the common cold and minor arthritis pain, plus temporary fever reduction.

How Naproxen works

▾

Naproxen blocks the COX-1 and COX-2 enzymes. That reduces prostaglandins, chemicals that sensitize nerves to pain and drive inflammation. Naproxen has pain-relieving, anti-inflammatory and fever-reducing effects.

Naproxen sodium is a more rapidly absorbed form used for pain relief.

Naproxen dosage

▾

Naproxen is taken by mouth. Prescription tablets and suspension are usually taken twice a day, and controlled-release tablets once a day. Your prescriber decides the dose, which may be adjusted based on how you respond.

  • Over-the-counter products: take every 8 to 12 hours while symptoms last, with a full glass of water.
  • Aleve capsules: taking them with food may make them work more slowly.
  • Use the smallest effective dose, and do not exceed the package directions.

Dosing details from the FDA-approved label

From the Naproxen prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis (naproxen sodium extended-release tablets)
    • Two 375 mg or 500 mg tablets once daily, or one 750 mg tablet once daily
    • In patients who tolerate lower doses well, may be increased to two 750 mg tablets (1,500 mg) or three 500 mg tablets (1,500 mg) once daily for limited periods
    • A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients
  • Management of Pain, Primary Dysmenorrhea, and Acute Tendinitis and Bursitis (naproxen sodium extended-release tablets)
    • Two 500 mg tablets (1,000 mg) once daily
    • For greater analgesic benefit, two 750 mg tablets (1,500 mg) or three 500 mg tablets (1,500 mg) may be used for a limited period
    • Maximum: Thereafter, the total daily dose should not exceed two 500 mg tablets (1,000 mg)
  • Acute Gout (naproxen sodium extended-release tablets)
    • Two to three 500 mg tablets (1,000 to 1,500 mg) once daily on the first day, followed by two 500 mg tablets (1,000 mg) once daily, until the attack has subsided
  • Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis (naproxen and naproxen sodium tablets)
    • Naproxen tablets 250 mg (one-half tablet) 500 mg twice daily
    • Naproxen sodium tablets 275 mg (one-half tablet) 550 mg twice daily
    • Dose may be adjusted up or down
    • In patients who tolerate lower doses well, may be increased to naproxen 1500 mg/day for up to 6 months
  • Polyarticular Juvenile Idiopathic Arthritis
    • Approximately 10 mg/kg total daily dose of naproxen given in 2 divided doses
    • Dosing with naproxen tablets is not appropriate for children weighing less than 50 kilograms; a liquid formulation may be more appropriate
  • Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis (naproxen sodium tablets)
    • Starting dose 550 mg of naproxen sodium followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as required
    • Maximum: Initial total daily dose should not exceed 1375 mg of naproxen sodium; thereafter, total daily dose should not exceed 1100 mg of naproxen sodium
  • Acute Gout (naproxen and naproxen sodium tablets)
    • Starting dose 750 mg of naproxen tablets followed by 250 mg every 8 hours until the attack has subsided
    • Naproxen sodium tablets may be used at a starting dose of 825 mg followed by 275 mg every 8 hours
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2 ) RA, OA, and AS: The dosage is two 375 mg or 500 mg tablets once daily, or one 750 mg tablet once daily. Management of Pain, PD, and Acute Tendinitis and Bursitis: The dosage is two 500 mg tablets once daily. For patients requiring greater analgesic benefit, two 750 mg tablets or three 500 mg tablets may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets For the treatment of Acute Gout: The dosage is two to three 500 mg tablets once daily on the first day, followed by two 500 mg tablets once daily, until the attack has subsided. 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of Naproxen Sodium Controlled-Release Tablets and other treatment options before deciding to use Naproxen Sodium Controlled-Release Tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. After observing the response to initial therapy with Naproxen Sodium Controlled-Release Tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. 2.2 Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis The recommended starting dose of Naproxen Sodium Controlled-Release Tablets in adults is two Naproxen Sodium Controlled-Release 375 mg tablets (750 mg) once daily, one Naproxen Sodium Controlled-Release 750 mg (750 mg) once daily, or two Naproxen Sodium Controlled-Release 500 mg tablets (1,000 mg) once daily. Patients already taking naproxen 250 mg, 375 mg, or 500 mg twice daily (morning and evening) may have their total daily dose replaced with Naproxen Sodium Controlled-Release Tablets as a single daily dose. During long-term administration, the dose of Naproxen Sodium Controlled-Release Tablets may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses of Naproxen Sodium Controlled-Release Tablets well, the dose may be increased to two Naproxen Sodium Controlled-Release 750 mg tablets (1,500 mg), or three Naproxen Sodium Controlled-Release 500 mg tablets (1,500 mg) once daily for limited periods when a higher level of anti-inflammatory/analgesic activity is required.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Naproxen side effects

▾

Common side effects

  • Headache
  • Indigestion or heartburn
  • Flu-like symptoms
  • Nausea
  • Diarrhea or constipation
  • Abdominal pain
  • Swelling (edema)
  • Dizziness or drowsiness

When to get medical help

  • Get emergency help for chest pain, shortness of breath, weakness on one side of the body or slurred speech. These can signal a heart attack or stroke.
  • Call your doctor right away for black or bloody stools, vomiting blood, or severe stomach pain. These can signal stomach or intestinal bleeding.
  • Stop naproxen and get help if you have a skin rash, blisters or other signs of allergy. Serious skin reactions can happen without warning.
  • Seek emergency help for signs of a severe allergic reaction (anaphylaxis).
  • Call your doctor for yellow skin or eyes, unusual tiredness, nausea or flu-like symptoms. These can signal liver problems.
  • Tell your doctor about swelling, weight gain or worsening heart failure symptoms.

Common side effects include:

  • Headache
  • Indigestion and heartburn
  • Flu-like symptoms
  • Nausea, diarrhea, constipation and abdominal pain
  • Swelling, dizziness and drowsiness
  • Ringing in the ears

Seek help right away for signs of GI bleeding, heart attack or stroke, serious skin reactions, severe allergic reaction, or liver problems.

Naproxen warnings and precautions

▾
  • Heart attack and stroke: risk can begin early and rises with higher doses and longer use.
  • Stomach bleeding and ulcers: can occur without warning, especially in older adults and people with prior ulcers.
  • Blood pressure, heart failure and swelling: NSAIDs can worsen these.
  • Kidney and liver effects: can harm kidneys and liver in some people.
  • Skin and allergic reactions: can be serious and fatal.
  • Pregnancy: can harm the unborn baby in later pregnancy.

Naproxen interactions

▾

Naproxen can clash with several medicines.

  • Warfarin, aspirin, SSRIs and SNRIs: increased bleeding risk.
  • Other NSAIDs: more GI toxicity without added benefit.
  • ACE inhibitors, ARBs, beta-blockers and diuretics: weaker blood pressure effect and possible kidney problems.
  • Lithium, methotrexate, digoxin, cyclosporine and pemetrexed: higher levels or toxicity.
  • Antacids, sucralfate and cholestyramine: delayed naproxen absorption.
  • Probenecid: raises naproxen levels.

Interactions listed in the FDA-approved label

From the Naproxen prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Anticoagulants (e.g., warfarin), antiplatelet agents, SSRIs, SNRIs (drugs that interfere with hemostasis): Naproxen and anticoagulants have a synergistic effect on bleeding, with increased risk of serious bleeding compared to either drug alone; SSRIs/SNRIs with an NSAID may potentiate bleeding risk. Monitor patients for signs of bleeding.
  • Aspirin: Lower dose naproxen interfered with the antiplatelet effect of low-dose immediate-release aspirin, and concomitant use with analgesic doses of aspirin increased GI adverse reactions and bleeding risk. For patients on low-dose aspirin for cardioprotection needing intermittent analgesics, consider an NSAID that does not interfere or non-NSAID analgesics; concomitant use with analgesic doses of aspirin is not generally recommended.
  • ACE inhibitors, angiotensin receptor blockers, beta-blockers: NSAIDs may diminish the antihypertensive effect; in elderly, volume-depleted or renally impaired patients, co-administration with ACE inhibitors or ARBs may deteriorate renal function, including possible acute renal failure. Monitor blood pressure; monitor for worsening renal function in at-risk patients; ensure adequate hydration and assess renal function at the beginning and periodically.
  • Diuretics (loop and thiazide): NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. Observe patients for signs of worsening renal function and for diuretic efficacy including antihypertensive effects.
  • Digoxin: Concomitant use has been reported to increase serum concentration and prolong the half-life of digoxin. Monitor serum digoxin levels.
  • Lithium: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. Monitor patients for signs of lithium toxicity.
  • Methotrexate: May increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Monitor patients for methotrexate toxicity.
  • Cyclosporine: May increase cyclosporine's nephrotoxicity. Monitor patients for signs of worsening renal function.
  • Other NSAIDs or salicylates (e.g., diflunisal, salsalate): Increases the risk of GI toxicity, with little or no increase in efficacy. Concomitant use is not recommended.
  • Pemetrexed: May increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. In patients with creatinine clearance 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity; avoid short half-life NSAIDs for two days before, the day of, and two days after pemetrexed; interrupt longer half-life NSAIDs for at least five days before, the day of, and two days after.
Read the label’s full interactions text

7 DRUG INTERACTIONS See Table 1 for clinically significant drug interactions with naproxen. Table 1: Clinically Significant Drug Interactions with naproxen Drugs That Interfere with Hemostasis Clinical Impact: • Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of naproxen tablets or naproxen sodium tablets with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [ see Warnings and Precautions ( 5.12 ) ]. Aspirin Clinical Impact: A pharmacodynamic (PD) study has demonstrated an interaction in which lower dose naproxen (220mg/day or 220mg twice daily) interfered with the antiplatelet effect of low-dose immediate-release aspirin, with the interaction most marked during the washout period of naproxen ( see 12.2 Pharmacodynamics) . There is reason to expect that the interaction would be present with prescription doses of naproxen or with enteric-coated low-dose aspirin; however, the peak interference with aspirin function may be later than observed in the PD study due to the longer washout period. Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿311 supplements and herbs with documented Naproxen interactions, ranked by severity Check Naproxen against a supplement or herb →

Before taking Naproxen

▾
  • Do not use if allergic to naproxen or if aspirin or NSAIDs caused asthma, hives or allergic reactions.
  • Do not use around CABG surgery.
  • Be careful with past ulcers or GI bleeding, heart disease, high blood pressure, heart failure, or kidney or liver disease.
  • Pregnancy: limit use from about 20 weeks and avoid it from about 30 weeks.
  • NSAIDs are linked to reversible infertility.
  • Older adults face higher risk of serious GI events.
  • Children under 12: ask a doctor before using over-the-counter products.

Naproxen overdose

▾

Overdose can cause lethargy, drowsiness, nausea, vomiting and stomach pain. GI bleeding can occur, and rarely high blood pressure, acute kidney failure, slowed breathing and coma. Some people had convulsions. There is no specific antidote, so treatment is supportive. Contact a poison control center at 1-800-222-1222.

What Naproxen does in the body

▾

In a study of healthy volunteers, naproxen taken with low-dose immediate-release aspirin reduced aspirin's antiplatelet effect. The interference was greater when naproxen was taken before aspirin. It also lingered after naproxen was stopped.

How your body processes Naproxen

▾

Naproxen is rapidly and completely absorbed from the gut. Naproxen tablets peak in about 2 to 4 hours and naproxen sodium in about 1 to 2 hours. Delayed-release tablets dissolve in the small intestine, so absorption is later. Food slows delayed-release tablet absorption. Naproxen is broken down in the liver, and about 95% leaves in the urine. Its half-life is 12 to 17 hours, with steady levels reached in 4 to 5 days.

How to store Naproxen

▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) . Dispense in well-closed containers.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

311

Supplements & herbs that interact with Naproxen

311 supplements and herbal products have documented interactions with Naproxen in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 7
  • Moderate · 260
  • Minor · 44
ACTIVATED CHARCOAL Major ASARABACCA Major BEER Major DANSHEN Major PIRACETAM Major SIBERIAN COCKLEBUR Major WINE Major ACONITE Moderate +303 more
Every supplement checked against Naproxen — ranked by severity The full interaction hub: 7 major · 260 moderate · 44 minor · every one linked to its full report. Check Naproxen against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Naproxen has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

FOLIC ACID Insufficient Evidence
See the full Naproxen nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Naproxen: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Naproxen — the kind of thing our pharmacy team would talk through with you at the counter.

What is naproxen used for?

▾
It relieves pain, inflammation and fever. Prescription versions treat arthritis, tendonitis, bursitis, acute gout and painful periods. Over-the-counter versions handle minor aches like headache, backache, toothache and cramps.

How should I take it?

▾
Take it by mouth with a full glass of water. Over-the-counter products are taken every 8 to 12 hours while symptoms last, and you should use the smallest dose that works. For prescription products, follow your prescriber's directions.

What side effects should I expect?

▾
Headache, indigestion, heartburn, nausea and swelling are common. Call your doctor if you have black stools, vomit blood, a rash, yellow skin or eyes, or chest pain.

Can I take it with aspirin or other pain relievers?

▾
Usually not. Combining naproxen with other NSAIDs or aspirin raises bleeding risk with little added benefit. Naproxen can also interfere with low-dose aspirin taken for your heart, so check with me first.

Is it safe in pregnancy?

▾
Not in later pregnancy. Use is limited from about 20 weeks and should be avoided from about 30 weeks. Talk with your doctor if you are pregnant or trying to conceive.

Is Naproxen available over the counter?

▾
Both. Some Naproxen products are sold over the counter and others need a prescription. According to their FDA listings, the tablet and extended-release tablet forms are sold both ways, at different strengths or package sizes, the capsule form is sold over the counter and the delayed-release tablet and oral suspension forms need a prescription. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Naproxen first available?

▾
The earliest FDA record we hold for Naproxen is from 1994: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Naproxen was first used.

Who makes Naproxen?

▾
142 companies currently list Naproxen products in the FDA's NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, Bayer HealthCare LLC.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Naproxen on HelloPharmacist

📊Naproxen supplement interactions311 checked — ranked by severity 🌿Drug & Supplement CheckerNaproxen vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Naproxen NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Naproxen Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Naproxen forms and strengths (how it comes)

Naproxen is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Aleve All Day Pain Relief Back And Muscle Pain Basic Care Naproxen Sodium DG Health Naproxen Sodium Flanax Good Sense Naproxen Sodium Naproxen Sodium BACK AND MUSCLE PAIN Naproxen Sodium HEADACHE PAIN Topcare All Day Pain Relief
How this form is used
What it may be used for
  • All Day Pain Relief tablets temporarily relieve minor aches and pains and reduce fever.
Important instructions
  • All Day Pain Relief tablets: adults and children 12 and older take 1 tablet every 8 to 12 hours while symptoms last.
  • All Day Pain Relief: drink a full glass of water with each dose.
Available strengths 7 strengths
200 mg 220 mg 250 mg 275 mg 375 mg 500 mg
Show 1 more strength Show fewer strengths
550 mg
811 FDA-listed product records ⓘ

Capsule

By mouth
Brands Aleve All Day Relief
How this form is used
Important instructions
  • Aleve liquid-filled capsules: adults and children 12 and older take 1 capsule every 8 to 12 hours while symptoms last.
  • Aleve: if taken with food, it may take longer to work.
  • Aleve: children under 12 should ask a doctor.
Available strengths 1 strength
220 mg
83 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Brands Naprelan
How this form is used
What it may be used for
  • Naproxen Sodium Controlled-Release Tablets are used for arthritis, tendinitis, bursitis, acute gout, primary dysmenorrhea and mild to moderate pain.
Important instructions
  • Naproxen Sodium Controlled-Release Tablets are generally taken once daily.
Available strengths 4 strengths
220 mg 375 mg 500 mg 750 mg
34 FDA-listed product records ⓘ

Delayed-release tablet

By mouth
Available strengths 2 strengths
375 mg 500 mg
15 FDA-listed product records ⓘ

Oral suspension

By mouth
How this form is used
What it may be used for
  • Naproxen Oral Suspension is used for rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, tendonitis, bursitis, acute gout, pain and primary dysmenorrhea.
Important instructions
  • Naproxen Oral Suspension is generally taken twice daily, measured as a liquid dose.
Available strengths 2 strengths
25 mg/mL 125 mg/5 mL
13 FDA-listed product records ⓘ

Naproxen on the U.S. market: products, makers and brands

How Naproxen appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

142 companies list 463 Naproxen product records with the FDA, mostly as tablet, capsule, extended-release tablet; the earliest marketing or approval year on record is 1994. Brand names on the directory include Aleve, Anaprox, Anaprox DS and 13 more; the rest are generics.

5
Dose forms ⓘ
142
Labelers (makers, repackagers, distributors)
40
Brand names
463
FDA-listed product records ⓘ
1994
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (27) · Kit (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack6%
A-S Medication Solutions5%
Bayer HealthCare LLC.4%
Proficient Rx LP3%
Dr.Reddy's Laboratories Inc2%
Granules India Ltd2%
Other makers78%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Naproxen is used (Medicaid data)

A general measure of how commonly Naproxen is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Naproxen is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

2,556,513
Medicaid prescriptions filled (Q1–Q4 2025)
$32.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Naproxen prescribed? Of the 1,601 medications we measure, Naproxen ranks #92 by Medicaid prescriptions — more than 94% of them.

Where Naproxen ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #92 of 1,601
#87 Sodium Chloride 2,643,128 Rx #88 Methylprednisolone 2,620,269 Rx #89 Ketoconazole 2,593,228 Rx #90 Ketoconazole Topical 2,579,373 Rx #91 Olanzapine 2,565,436 Rx #92 Naproxen 2,556,513 Rx #93 Methylprednisolone Inj... 2,550,742 Rx #94 Spironolactone 2,528,169 Rx #95 Oseltamivir 2,322,109 Rx #96 Insulin Lispro Injecti... 2,318,237 Rx #97 Methocarbamol 2,261,221 Rx

Utilization by Naproxen product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 500 mg oral tablet is the most-dispensed Naproxen product — about 84% of these Medicaid prescriptions.

naproxen 500 MG Oral Tablet Most dispensed

2,134,714 Medicaid prescriptions (Q1–Q4 2025) 84% of Naproxen prescriptions shown $20.8M gross reimbursement (before rebates) ≈ $9.75 per prescription (gross)

Summed across the 18 of 479 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198014

naproxen 375 MG Oral Tablet

161,421 Medicaid prescriptions (Q1–Q4 2025) 6% of Naproxen prescriptions shown $1.5M gross reimbursement (before rebates) ≈ $9.59 per prescription (gross)

Summed across the 9 of 209 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198012

naproxen 250 MG Oral Tablet

141,990 Medicaid prescriptions (Q1–Q4 2025) 6% of Naproxen prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $10 per prescription (gross)

Summed across the 12 of 165 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198013

naproxen sodium 550 MG Oral Tablet

42,908 Medicaid prescriptions (Q1–Q4 2025) 2% of Naproxen prescriptions shown $801,232 gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 6 of 190 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 849431

naproxen 500 MG Delayed Release Oral Tablet

36,231 Medicaid prescriptions (Q1–Q4 2025) 1% of Naproxen prescriptions shown $3.5M gross reimbursement (before rebates) ≈ $96 per prescription (gross)

Summed across the 3 of 53 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311915

naproxen 25 MG/ML Oral Suspension

15,803 Medicaid prescriptions (Q1–Q4 2025) <1% of Naproxen prescriptions shown $2.9M gross reimbursement (before rebates) ≈ $185 per prescription (gross)

Summed across the 5 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311913

naproxen sodium 220 MG Oral Tablet

10,805 Medicaid prescriptions (Q1–Q4 2025) <1% of Naproxen prescriptions shown $107,442 gross reimbursement (before rebates) ≈ $9.94 per prescription (gross)

Summed across the 16 of 851 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 849574

naproxen sodium 275 MG Oral Tablet

6,127 Medicaid prescriptions (Q1–Q4 2025) <1% of Naproxen prescriptions shown $82,622 gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 4 of 44 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 849398

naproxen 375 MG Delayed Release Oral Tablet

3,646 Medicaid prescriptions (Q1–Q4 2025) <1% of Naproxen prescriptions shown $125,284 gross reimbursement (before rebates) ≈ $34 per prescription (gross)

Summed across the 3 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 603103

24 HR naproxen 500 MG Extended Release Oral Tablet

1,587 Medicaid prescriptions (Q1–Q4 2025) <1% of Naproxen prescriptions shown $748,306 gross reimbursement (before rebates) ≈ $472 per prescription (gross)

Summed across the 3 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1116339

24 HR naproxen 375 MG Extended Release Oral Tablet

916 Medicaid prescriptions (Q1–Q4 2025) <1% of Naproxen prescriptions shown $545,026 gross reimbursement (before rebates) ≈ $595 per prescription (gross)

Summed across the 3 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1116320

24 HR naproxen 750 MG Extended Release Oral Tablet

365 Medicaid prescriptions (Q1–Q4 2025) <1% of Naproxen prescriptions shown $220,321 gross reimbursement (before rebates) ≈ $604 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1116349

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Naproxen, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 83 of 2,060 listed Naproxen NDCs with Medicaid activity.

Compare Naproxen products

A representative set of FDA-listed product records for Naproxen — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 106 of 463 products — FDA National Drug Code Directory. See every product, package size and price: browse all 463 Naproxen NDCs →

Naproxen recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 4 Naproxen recalls since July 2021, covering 5 product listings. Three of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Apr 20, 2026 · Acella Pharmaceuticals, LLC
Chemical contamination; presence of lead and lithium above specification
  • NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16 Lots: Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028. FDA record D-0523-2026 →
Ongoing Class II Mar 13, 2025 · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
  • Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals… Lots: Lot # 17231956, exp. date Aug-25 FDA record D-0346-2025 →
Ongoing Class II Nov 7, 2023 · Glenmark Pharmaceuticals Inc., USA
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
  • Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah,… Lots: Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484: Exp 8/2025 Lot# 19233490; Exp 8/2025 FDA record D-0124-2024 →
Class II Aug 27, 2021 · Terminated · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
  • Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 074… Lots: Lots: a) 29190082 Exp. 09/30/2021; 29190083 Exp. 09/30/2021; 29190084 Exp. 10/31/2021; 29190085 Exp. 10/31/2021; 29200001 Exp. 12/31/2021; 29200003 Exp. 01/31/2022; 29200004 Exp. 01/31/2022; 29200005 Exp. 01/31/2022; 29200012 Exp. 02/28/20… FDA record D-0822-2021 →
  • Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuti… Lots: Lots: 29190087 Exp. 10/31/2021; 29190088 Exp. 10/31/2021; 29190089 Exp. 10/31/2021; 29200077 Exp. 11/30/2022; 29200078 Exo, 11/30/2022 FDA record D-0821-2021 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Naproxen RxCUI 7258 6 dose forms · 16 strengths
  1. Dose form (SCDF) Delayed Release Oral Tablet RxCUI 373009 In current FDA listings
    Clinical drug / strength (SCD) 250 MG RxCUI 105918 375 MG RxCUI 603103 500 MG RxCUI 311915
  3. Dose form (SCDF) Oral Capsule RxCUI 373002 In current FDA listings
    Clinical drug / strength (SCD) sodium 220 MG RxCUI 1112231
  4. Dose form (SCDF) Oral Suspension RxCUI 373004 In current FDA listings
    Clinical drug / strength (SCD) 25 MG/ML RxCUI 311913
  6. Dose form (SCDF) Rectal Suppository RxCUI 373003 No current FDA listing
    Clinical drug / strength (SCD) 500 MG RxCUI 199490

Look up RxCUI 7258 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Naproxen brand names

Naproxen is sold under 16 brand names in the FDA directory — Aleve, Anaprox, Anaprox DS, EC-Naprosyn and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Aleve Anaprox Anaprox DS EC-Naprosyn Flanax Naprelan Wal-Proxen All Day Pain Relief Good Sense Naproxen Sodium Back And Muscle Pain Naproxen Sodium Back and Muscle Pain Naproxen Sodium Headache Pain DG Health Naproxen Sodium Basic Care Naproxen Sodium All Day Relief Topcare All Day Pain Relief

Who makes Naproxen: manufacturers and labelers

142 companies list Naproxen products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, Bayer HealthCare LLC.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 29 A-S Medication Solutions 24 Bayer HealthCare LLC. 19 Proficient Rx LP 12 Dr.Reddy's Laboratories Inc 9 Granules India Ltd 9 NuCare Pharmaceuticals,Inc. 9 PD-Rx Pharmaceuticals, Inc. 9 Advanced Rx of Tennessee, LLC 8 Aphena Pharma Solutions - Tennessee, LLC 8 Aurobindo Pharma Limited 8 Preferred Pharmaceuticals Inc. 8 Aurohealth LLC 7 Belmora LLC 7 Amazon.com Services LLC 6 Asclemed USA, Inc. 6 Lil' Drug Store Products, Inc 6 Northwind Health Company, LLC 6 Remedyrepack Inc. 6 Upsher-Smith Laboratories, LLC 6 Amneal Pharmaceuticals of New York LLC 5 Cipla USA Inc. 5 Coupler LLC 5 Glenmark Pharmaceuticals Inc., USA 5

…and 118 more on the FDA NDC directory.

Naproxen drug class (RxNorm)

Naproxen belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Propionic acid derivatives, Antiinflammatory products for vaginal administration, Antiinflammatory preparations, non-steroids for topical use
How it works Cyclooxygenase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Naproxen page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 23, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Naproxen.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Naproxen after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
427
Finished products in the current FDA directory
463
Companies listing them (makers, repackagers, distributors)
142
FDA labeler codes behind them ⓘ
138
Linked representative label ⓘ
Zameer Pharmaceuticals LLC
Linked label effective
Aug 23, 2025
Composite sections available
24
Linked SPL Set ID
d2e5553a-7c90-407c-9f07-3be65560c23a
Linked SPL Document ID
1e574b03-a038-453b-b84f-9437fc2df0f8
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Zameer Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →