Skip to the answer

Diclofenac

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) used for pain and inflammation, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, period pain, acute pain, strains and sprains, and migraine attacks, depending on the product.

Brand names CambiaZipsorZorvolexCataflamVoltaren XR +11 more
Drug class Nonsteroidal Anti-inflammatory Drug
Rx/OTC Forms 9
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 226 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 3, 2026 🚨Recall on record · 3
Other forms & routes:
Ophthalmic Transdermal
Diclofenac 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

Diclofenac, around since about 1980 and available generically, is one of the most widely used NSAIDs (nonsteroidal anti-inflammatory drugs). It blocks the COX-1 and COX-2 enzymes to lower prostaglandins, the chemicals behind pain and swelling, and treats arthritis, strains and sprains, period pain or migraine depending on the form. Most people handle short courses well, noticing mainly indigestion or nausea from the oral forms and mild redness or dryness where the gel goes on. Its boxed warning flags a higher risk of heart attack, stroke and serious stomach or gut bleeding that can be fatal and strike without warning, so use the lowest dose for the shortest time.

Clinical pearls

  • Do not use the gel alongside ibuprofen, naproxen or other oral NSAIDs, and check cold and pain products for hidden NSAIDs.
  • Diclofenac does not replace low-dose aspirin for heart protection, and taking both raises the risk of stomach bleeding.
  • Keep treated skin out of the sun, and measure each gel dose with the reusable dosing card in the carton.
  • It can blunt blood pressure medicines and water pills and strain the kidneys, so recheck your blood pressure after starting.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Diclofenac and other NSAIDs raise the risk of heart attack, stroke, and serious stomach or intestinal bleeding, which can be fatal.

The heart risk can begin early in treatment and may grow the longer you use it. The stomach risk (bleeding, ulcers, and holes in the stomach or intestines) can strike at any time, often with no warning symptoms. Older adults and people with past stomach ulcers or bleeding are at the highest risk.

Diclofenac gel must not be used around coronary artery bypass graft (CABG) heart surgery. Seek emergency care for chest pain, shortness of breath, sudden weakness, black stools, or vomiting blood.

Read the full warning on DailyMed →
How you get itPrescription and over the counter
Comes asTopical cream, ointment or gel, Delayed-release tablet, Topical solution +6
Earliest FDA record1980
Companies listing it with the FDA226
FDA label last updatedDec 1, 2023
FDA’s strongest warning (boxed)Yes, read the warning

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

What Diclofenac is used for

▾

Diclofenac is used for several kinds of pain and inflammation, depending on the product.

  • Delayed-release tablets: osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
  • Extended-release tablets: osteoarthritis and rheumatoid arthritis.
  • Potassium tablets (including Lofena): period pain, mild to moderate pain, osteoarthritis and rheumatoid arthritis.
  • Potassium capsules: mild to moderate acute pain in adults.
  • Potassium oral solution: acute migraine attacks in adults.
  • Topical gel: osteoarthritis pain of the knees and hands.
  • Topical solution: osteoarthritis of the knee.
  • Flector and diclofenac epolamine patches: acute pain from minor strains, sprains and bruises in adults and children 6 and older.

How Diclofenac works

▾

Diclofenac blocks the COX-1 and COX-2 enzymes that make prostaglandins. Prostaglandins make nerves more sensitive to pain and drive inflammation. By lowering them, diclofenac reduces pain and swelling. It also has fever-reducing properties.

The label notes the exact mechanism is not completely understood.

Diclofenac dosage

▾

Dosing depends on the product. Oral forms are taken by mouth, while gels, solutions and patches are applied to skin. Topical gel is measured with the included dosing card. Patches are applied once or twice daily as directed by the product.

  • Use the lowest effective dose for the shortest time.
  • Food does not change how much oral diclofenac is absorbed but can delay the start of its effect.
  • Follow your prescriber and the product label.

Dosing details from the FDA-approved label

From the Diclofenac 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.

  • Lower extremities (foot, ankle, knee) - diclofenac sodium topical gel
    • Apply the gel (4 g) to the affected foot, ankle, or knee 4 times daily
    • Maximum: Do not apply more than 16 g daily to any single joint of the lower extremities
    • Measure onto the dosing card to the 4 g line; total dose should not exceed 32 g per day over all affected joints
  • Upper extremities (hand, wrist, elbow) - diclofenac sodium topical gel
    • Apply the gel (2 g) to the affected hand, wrist, or elbow 4 times daily
    • Maximum: Do not apply more than 8 g daily to any single joint of the upper extremities
    • Measure onto the dosing card to the 2 g line; total dose should not exceed 32 g per day over all affected joints
  • Osteoarthritis of the knee(s) - diclofenac sodium topical solution
    • 40 drops per knee, 4 times a day
    • Dispense 10 drops at a time onto the knee or into the hand first, spread evenly, repeat until 40 drops are applied
    • Apply to clean, dry skin; amounts exceeding or less than the recommended dose have not been studied and are not recommended
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. Apply diclofenac sodium topical gel gently to lesion areas twice daily to adequately cover each lesion. Use 0.5 g of gel (pea size) on each 5 cm x 5 cm lesion site. The recommended duration of therapy is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be re-evaluated and management reconsidered. Avoid contact of diclofenac sodium topical gel with eyes and mucous membranes. • Use the lowest effective dosage for shortest duration consistent with the individual patient treatment goals. ( 2 ) • Apply to lesion areas twice daily to adequately cover each lesion. ( 2 ) • Use 0.5 g of gel (pea size) on each 5 cm x 5 cm lesion site. ( 2 ) • The recommended duration of therapy is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be re-evaluated and management reconsidered. ( 2 ) • Avoid contact in eyes, nose, or mouth. ( 2 )

Read the full Dosage and Administration section on DailyMed →

Diclofenac side effects

▾

Common side effects

  • Stomach pain or cramps
  • Nausea and indigestion
  • Diarrhea or constipation
  • Gas and bloating
  • Headache
  • Dizziness
  • Rash or itching
  • Skin irritation, dryness or redness where gel is applied

When to get medical help

  • Call 911 for chest pain, shortness of breath, weakness on one side, or slurred speech, which can signal a heart attack or stroke.
  • Get help for black or bloody stools, vomiting blood, or severe stomach pain. These can be signs of stomach or intestinal bleeding, ulcers, or a hole in the gut. They can happen without warning.
  • Seek emergency help for swelling of the face, lips or tongue, or trouble breathing, which can signal a severe allergic reaction.
  • Stop the medicine and call your doctor at the first sign of a skin rash, blisters, or other allergic signs.
  • Call your doctor for nausea, unusual tiredness, itching, yellow skin or eyes, dark urine, or upper right belly pain. These can signal liver problems.
  • Tell your doctor about swelling, rapid weight gain, or worsening heart failure symptoms.
  • Report new or worsening high blood pressure.

Common side effects vary with the form.

  • Stomach pain, cramps, nausea and indigestion
  • Diarrhea, constipation and gas
  • Headache and dizziness
  • Rash and itching
  • With topical products: skin irritation, dryness, redness and peeling at the application site

Get help right away for signs of bleeding, a severe allergic reaction, liver problems, a serious skin reaction, or heart attack or stroke symptoms.

Diclofenac warnings and precautions

▾
  • Heart attack and stroke: The risk can start early and rises with higher doses and longer use.
  • Stomach bleeding, ulcers and perforation: These can happen without warning and are more likely in older adults and people with prior ulcers.
  • Liver injury: Liver tests are often checked during longer treatment.
  • Blood pressure, fluid retention and heart failure: NSAIDs can worsen all three.
  • Kidney harm: Dehydration, kidney disease and heart failure raise the risk.
  • Allergic and skin reactions: These include anaphylaxis, Stevens-Johnson syndrome, and DRESS.
  • Sun sensitivity: Avoid sunlight on areas treated with the gel.

Diclofenac interactions

▾

Diclofenac can clash with several kinds of medicine.

  • Warfarin, aspirin, SSRIs and SNRIs: more bleeding risk.
  • Other NSAIDs and salicylates: more stomach toxicity.
  • ACE inhibitors, ARBs, beta-blockers and diuretics: weaker blood pressure control and possible kidney strain.
  • Digoxin: higher digoxin levels.
  • Lithium: higher lithium levels.
  • Methotrexate, cyclosporine and pemetrexed: greater toxicity risk.

Interactions listed in the FDA-approved label

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

  • Drugs that interfere with hemostasis (anticoagulants e.g. warfarin, antiplatelet agents e.g. aspirin, SSRIs, SNRIs): Diclofenac and anticoagulants have a synergistic effect on bleeding, and concomitant use increases the risk of serious bleeding compared to either drug alone; SSRIs/SNRIs with an NSAID may potentiate the risk of bleeding more than an NSAID alone. Monitor patients for signs of bleeding.
  • Aspirin: Concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions compared to the NSAID alone. Concomitant use with analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding; diclofenac gel is not a substitute for low dose aspirin for cardiovascular protection.
  • ACE inhibitors, angiotensin receptor blockers, and beta-blockers: NSAIDs may diminish the antihypertensive effect of these drugs; in elderly, volume-depleted, or renally impaired patients, NSAIDs with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure, usually reversible. Monitor blood pressure; in elderly, volume-depleted, or renally impaired patients on ACE inhibitors or ARBs, monitor for signs of worsening renal function.
  • Diuretics: 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, in addition to assuring diuretic efficacy including antihypertensive effects.
  • Digoxin: Concomitant use has been reported to increase the 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; mean minimum lithium concentration increased 15% and renal clearance decreased by approximately 20%. Monitor patients for signs of lithium toxicity.
  • Methotrexate: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Monitor patients for methotrexate toxicity.
  • Cyclosporine: Concomitant use may increase cyclosporine's nephrotoxicity. Monitor patients for signs of worsening renal function.
  • Other NSAIDs or salicylates (e.g., diflunisal, salsalate): Concomitant use increases the risk of GI toxicity. Concomitant use is not recommended.
  • Pemetrexed: Concomitant use 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 NSAIDs with short half-lives (e.g., diclofenac) for two days before, the day of, and two days following pemetrexed administration.
Read the label’s full interactions text

7 DRUG INTERACTIONS See Table 2 for clinically significant drug interactions with diclofenac. Table 2: Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Clinical Impact: • Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac 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. 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 diclofenac sodium topical gel 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 ( 5.5 )] . Aspirin Clinical Impact: • In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see Warnings and Precautions ( 5.5 )] . Intervention: • Concomitant use of diclofenac sodium topical gel and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions ( 5.12 )] . Diclofenac sodium topical gel is not a substitute for low dose aspirin for cardiovascular protection.

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.

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

Before taking Diclofenac

▾
  • Do not use if allergic to diclofenac, or if aspirin or NSAIDs have caused asthma, hives or allergic reactions.
  • Do not use around coronary bypass (CABG) surgery.
  • Do not apply topical gel to damaged skin.
  • Tell your prescriber about ulcers, stomach bleeding, heart disease, recent heart attack, high blood pressure, heart failure, liver disease or kidney disease.
  • Pregnancy: avoid at about 30 weeks and later, and limit use from about 20 to 30 weeks.
  • Small amounts of diclofenac appear in breast milk.
  • NSAIDs may reduce fertility in some women.
  • Older adults face higher risk of serious side effects.
  • Diclofenac topical gel should not be used by children, while Flector and diclofenac epolamine patches are labeled for ages 6 and older.

Diclofenac overdose

▾

NSAID overdose symptoms usually include drowsiness, lethargy, nausea, vomiting and upper stomach pain, and they generally improve with supportive care. Stomach bleeding can occur. High blood pressure, kidney failure, slowed breathing and coma are rare. There is no specific antidote, so call Poison Control at 1-800-222-1222 or seek emergency care.

How your body processes Diclofenac

▾

After oral dosing, diclofenac is fully absorbed, but only about half reaches the bloodstream because the liver processes some first. Food does not change how much is absorbed but can delay it by 1 to 4.5 hours. Diclofenac binds tightly to blood proteins, is broken down by the liver, and is cleared mainly in urine. Skin products deliver much less drug into the blood than oral forms.

How to store Diclofenac

▾

Store at 20° to 25°C (68° to 77°F) . Protect from heat. Avoid freezing.

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

308

Supplements & herbs that interact with Diclofenac

308 supplements and herbal products have documented interactions with Diclofenac 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 · 266
  • Minor · 35
ACTIVATED CHARCOAL Major ASARABACCA Major BEER Major DANSHEN Major PIRACETAM Major SIBERIAN COCKLEBUR Major WINE Major ACONITE Moderate +300 more
Every supplement checked against Diclofenac — ranked by severity The full interaction hub: 7 major · 266 moderate · 35 minor · every one linked to its full report. Check Diclofenac 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

Diclofenac 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 Diclofenac 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.

Diclofenac: pharmacist answers to common questions

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

What is diclofenac for?

▾
It's an NSAID used for pain and inflammation. Depending on the form, that may be arthritis, period pain, acute pain, strains and sprains, or migraine attacks. Check that your product matches your condition.

How should I take it?

▾
Take oral forms by mouth and apply gels, solutions and patches to the skin as directed. Use the lowest dose for the shortest time that works. Food won't change how much you absorb, but it can delay relief a bit.

What side effects are normal?

▾
Stomach upset, nausea, gas, diarrhea or constipation, headache and dizziness are common. Skin products can cause dryness, redness or irritation where applied. Call me or your doctor if they bother you or don't settle.

When should I get help right away?

▾
Get emergency help for chest pain, trouble breathing, weakness on one side, black or bloody stools, vomiting blood, or swelling of the face or tongue. Stop it and call for a new rash, or for yellow skin or eyes and dark urine. These can be serious.

What can I not mix with diclofenac?

▾
Avoid other NSAIDs and take aspirin only if your doctor says so. Tell us if you take warfarin, antidepressants like SSRIs, blood pressure pills, diuretics, digoxin, lithium or methotrexate. Alcohol and smoking raise your stomach bleeding risk.

Is it safe in pregnancy?

▾
NSAIDs can harm a baby's kidneys and a key blood vessel, especially from about 20 weeks on. Avoid it at about 30 weeks and later. Talk to your prescriber if you're pregnant or trying to conceive.

Is Diclofenac available over the counter?

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

When was Diclofenac first available?

▾
The earliest FDA record we hold for Diclofenac is from 1980: 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 Diclofenac was first used.

Who makes Diclofenac?

▾
226 companies list Diclofenac products in the FDA's NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, Preferred Pharmaceuticals Inc.. That count includes repackagers and distributors as well as manufacturers, 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 Diclofenac on HelloPharmacist

📊Diclofenac supplement interactions308 checked — ranked by severity 🌿Drug & Supplement CheckerDiclofenac vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Diclofenac NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Diclofenac 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.

Diclofenac forms and strengths (how it comes)

Diclofenac is available in 9 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.

Topical cream, ointment or gel

By mouth · On the skin
Brands Arthritis Pain Reliever Arthritis Pain Relieving Voltaren
How this form is used
What it may be used for
  • Diclofenac sodium topical gel relieves osteoarthritis pain in joints suited to topical treatment, such as knees and hands. It was not evaluated for the spine, hip or shoulder.
  • Diclofenac sodium topical solution treats signs and symptoms of osteoarthritis of the knee.
Important instructions
  • Diclofenac sodium topical gel is measured with the dosing card in the carton and applied to the affected joint.
  • Diclofenac sodium topical solution goes on clean, dry skin. Wash your hands afterward, and keep it out of eyes, nose and mouth.
  • Let the treated knee dry fully before covering it or applying sunscreen or other products.
Available strengths 7 strengths
1 mg/100 g 1 mg/g 9.3 mg/g 0.01 g/g 10 mg/g 30 mg/g
Show 1 more strength Show fewer strengths
1 g/100 g
298 FDA-listed product records ⓘ

Delayed-release tablet

By mouth
How this form is used
What it may be used for
  • Diclofenac sodium delayed-release tablets relieve signs and symptoms of osteoarthritis and rheumatoid arthritis.
  • Diclofenac sodium delayed-release tablets are also used for acute or long-term relief of ankylosing spondylitis symptoms.
Important instructions
  • Diclofenac sodium delayed-release tablets should be used at the lowest effective dose for the shortest time.
Available strengths 3 strengths
25 mg 50 mg 75 mg
260 FDA-listed product records ⓘ

Topical solution

On the skin
Brands Pennsaid
Available strengths 2 strengths
16.05 mg/mL 20 mg/g
156 FDA-listed product records ⓘ

Tablet

By mouth
Brands Cataflam Lofena
How this form is used
What it may be used for
  • Diclofenac potassium tablets and Lofena treat primary dysmenorrhea (painful periods).
  • Diclofenac potassium tablets and Lofena relieve mild to moderate pain.
  • Diclofenac potassium tablets and Lofena relieve signs and symptoms of osteoarthritis and rheumatoid arthritis.
Important instructions
  • Lofena and diclofenac potassium tablets should be used at the lowest effective dose for the shortest time.
Available strengths 4 strengths
25 mg 50 mg 75 mg 100 mg
112 FDA-listed product records ⓘ

Skin patch

By mouth · On the skin · Through the skin
Brands Diclofenac Epolamine Flector Licart Xiclo
How this form is used
What it may be used for
  • Flector and diclofenac epolamine topical system treat acute pain from minor strains, sprains and contusions in adults and children 6 and older.
Important instructions
  • Flector and diclofenac epolamine topical system are applied as one patch to the most painful area twice a day.
  • Flector and diclofenac epolamine topical system should not go on damaged or broken skin.
  • If Flector begins to peel off, its edges may be taped down.
Available strengths 3 strengths
0.0125 g/g 0.013 g 16.05 mg/mL
44 FDA-listed product records ⓘ

Extended-release tablet

By mouth
How this form is used
What it may be used for
  • Diclofenac sodium extended-release tablets relieve signs and symptoms of osteoarthritis and rheumatoid arthritis.
Important instructions
  • Diclofenac sodium extended-release tablets should be used at the lowest effective dose for the shortest time.
Available strengths 1 strength
100 mg
36 FDA-listed product records ⓘ

Capsule

By mouth
Brands Zipsor Zorvolex
How this form is used
What it may be used for
  • Diclofenac potassium capsules relieve mild to moderate acute pain in adults.
Available strengths 3 strengths
18 mg 25 mg 35 mg
33 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Cambia
How this form is used
What it may be used for
  • Diclofenac potassium for oral solution treats acute migraine attacks, with or without aura, in adults 18 and older.
  • Diclofenac potassium for oral solution is not for preventing migraine, and has not been shown effective for cluster headache.
Available strengths 1 strength
50 mg
16 FDA-listed product records ⓘ

Eye drops

In the eye
Available strengths 1 strength
1 mg/mL
12 FDA-listed product records ⓘ

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

How Diclofenac 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.

226 companies list 1,027 Diclofenac product records with the FDA, mostly as topical cream, ointment or gel, delayed-release tablet, topical solution; the earliest marketing or approval year on record is 1980. Brand names on the directory include Cambia, Zipsor, Zorvolex and 13 more; the rest are generics.

9
Dose forms ⓘ
226
Labelers (makers, repackagers, distributors)
40
Brand names
1,027
FDA-listed product records ⓘ
1980
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 (47) · Kit (13) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack11%
A-S Medication Solutions9%
Preferred Pharmaceuticals Inc.7%
Remedyrepack Inc.7%
Proficient Rx LP6%
Advanced Rx Pharmacy of Tennessee, LLC6%
Other makers55%

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

How widely Diclofenac is used (Medicaid data)

A general measure of how commonly Diclofenac 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 Diclofenac 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.

4,673,607
Medicaid prescriptions filled (Q1–Q4 2025)
$142.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Diclofenac prescribed? Of the 1,601 medications we measure, Diclofenac ranks #44 by Medicaid prescriptions — more than 97% of them.

Where Diclofenac ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #44 of 1,601
#39 Montelukast 5,399,653 Rx #40 Azithromycin 5,254,152 Rx #41 Loratadine 5,204,681 Rx #42 Buspirone 5,180,004 Rx #43 Aripiprazole 5,031,681 Rx #44 Diclofenac Topical (ar... 4,673,607 Rx #45 Diclofenac Topical (ac... 4,673,607 Rx #46 Diclofenac 4,673,607 Rx #47 Lamotrigine 4,467,083 Rx #48 Cyclobenzaprine 4,437,147 Rx #49 Triamcinolone Topical 4,329,207 Rx

Utilization by Diclofenac 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 0.01 mg/mg topical gel is the most-dispensed Diclofenac product — about 72% of these Medicaid prescriptions.

diclofenac sodium 0.01 MG/MG Topical Gel Most dispensed

3,387,260 Medicaid prescriptions (Q1–Q4 2025) 72% of Diclofenac prescriptions shown $66.6M gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 23 of 255 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855633

diclofenac sodium 75 MG Delayed Release Oral Tablet

733,469 Medicaid prescriptions (Q1–Q4 2025) 16% of Diclofenac prescriptions shown $8.8M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 27 of 346 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855926

diclofenac sodium 50 MG Delayed Release Oral Tablet

232,998 Medicaid prescriptions (Q1–Q4 2025) 5% of Diclofenac prescriptions shown $2.8M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 19 of 217 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855906

diclofenac sodium 20 MG/ML Topical Solution

61,370 Medicaid prescriptions (Q1–Q4 2025) 1% of Diclofenac prescriptions shown $10.4M gross reimbursement (before rebates) ≈ $169 per prescription (gross)

Summed across the 8 of 39 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1487074

diclofenac potassium 50 MG Oral Tablet

61,179 Medicaid prescriptions (Q1–Q4 2025) 1% of Diclofenac prescriptions shown $907,855 gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 9 of 138 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855942

diclofenac sodium 0.03 MG/MG Topical Gel

56,803 Medicaid prescriptions (Q1–Q4 2025) 1% of Diclofenac prescriptions shown $2.8M gross reimbursement (before rebates) ≈ $50 per prescription (gross)

Summed across the 5 of 51 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855642

diclofenac potassium 25 MG Oral Tablet

56,007 Medicaid prescriptions (Q1–Q4 2025) 1% of Diclofenac prescriptions shown $41M gross reimbursement (before rebates) ≈ $732 per prescription (gross)

Summed across the 9 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857702

24 HR diclofenac sodium 100 MG Extended Release Oral Tablet

23,967 Medicaid prescriptions (Q1–Q4 2025) <1% of Diclofenac prescriptions shown $868,745 gross reimbursement (before rebates) ≈ $36 per prescription (gross)

Summed across the 4 of 119 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855657

Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch

21,190 Medicaid prescriptions (Q1–Q4 2025) <1% of Diclofenac prescriptions shown $6.3M gross reimbursement (before rebates) ≈ $299 per prescription (gross)

Summed across the 1 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855626

diclofenac sodium 1 MG/ML Ophthalmic Solution

16,149 Medicaid prescriptions (Q1–Q4 2025) <1% of Diclofenac prescriptions shown $267,199 gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 4 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 854801

diclofenac sodium 25 MG Delayed Release Oral Tablet

14,888 Medicaid prescriptions (Q1–Q4 2025) <1% of Diclofenac prescriptions shown $739,658 gross reimbursement (before rebates) ≈ $50 per prescription (gross)

Summed across the 4 of 28 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855664

diclofenac sodium 15 MG/ML Topical Solution

6,165 Medicaid prescriptions (Q1–Q4 2025) <1% of Diclofenac prescriptions shown $194,157 gross reimbursement (before rebates) ≈ $31 per prescription (gross)

Summed across the 2 of 81 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857700

diclofenac 25 MG Oral Capsule

1,081 Medicaid prescriptions (Q1–Q4 2025) <1% of Diclofenac prescriptions shown $335,097 gross reimbursement (before rebates) ≈ $310 per prescription (gross)

Summed across the 4 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 858342

diclofenac potassium 50 MG Powder for Oral Solution

1,081 Medicaid prescriptions (Q1–Q4 2025) <1% of Diclofenac prescriptions shown $263,456 gross reimbursement (before rebates) ≈ $244 per prescription (gross)

Summed across the 5 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859063

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 Diclofenac, 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 124 of 1,374 listed Diclofenac NDCs with Medicaid activity.

Compare Diclofenac products

A representative set of FDA-listed product records for Diclofenac — 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 200 of 1,027 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1,027 Diclofenac NDCs →

Diclofenac 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 3 Diclofenac recalls since July 2021. All of them are still ongoing or began in the last six months. 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 Jan 27, 2026 · SUN PHARMACEUTICAL INDUSTRIES INC
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
  • Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51… Lots: Lot # AD92721, Exp Date: 3/31/2027. FDA record D-0342-2026 →
Ongoing Class III Dec 22, 2025 · Cipla USA, Inc.
Failed PH Specifications
  • Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39 Lots: Batch XHBG; Exp. 08/31/2027 FDA record D-0291-2026 →
Ongoing Class II Jun 22, 2023 · ALEMBIC PHARMACEUTICALS, INC.
Defective Delivery System
  • Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceutic… Lots: Lot #: 220151, 220152, 220153, Exp. Date 11/2024 FDA record D-0941-2023 →

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) Diclofenac RxCUI 3355 15 dose forms · 30 strengths
  1. Dose form (SCDF) Delayed Release Oral Capsule RxCUI 438955 No current FDA listing
    Clinical drug / strength (SCD) sodium 25 MG RxCUI 1234844 sodium 50 MG RxCUI 1234853
  2. Dose form (SCDF) Delayed Release Oral Tablet RxCUI 371794 In current FDA listings
    Clinical drug / strength (SCD) sodium 25 MG RxCUI 855664 sodium 50 MG RxCUI 855906 sodium 75 MG RxCUI 855926
  3. Dose form (SCDF) Extended Release Oral Capsule RxCUI 371793 No current FDA listing
    Clinical drug / strength (SCD) 24 HR diclofenac sodium 100 MG RxCUI 411846 24 HR diclofenac sodium 75 MG RxCUI 411848
  4. Dose form (SCDF) Extended Release Oral Tablet RxCUI 371799 In current FDA listings
    Clinical drug / strength (SCD) sodium 75 MG RxCUI 857713 24 HR diclofenac sodium 100 MG RxCUI 855657
  5. Dose form (SCDF) Injectable Solution RxCUI 371795 No current FDA listing
    Clinical drug / strength (SCD) sodium 25 MG/ML RxCUI 857705
  7. Dose form (SCDF) Ophthalmic Solution RxCUI 378986 In current FDA listings
    Clinical drug / strength (SCD) sodium 1 MG/ML RxCUI 854801
  8. Dose form (SCDF) Oral Capsule RxCUI 376352 In current FDA listings
    Clinical drug / strength (SCD) 18 MG RxCUI 1442116 25 MG RxCUI 858342 35 MG RxCUI 1442128
  9. Dose form (SCDF) Oral Solution RxCUI 393225 In current FDA listings
    Clinical drug / strength (SCD) sodium 0.25 MG/ML RxCUI 857689
  10. Dose form (SCDF) Oral Tablet RxCUI 371798 In current FDA listings
    Clinical drug / strength (SCD) potassium 25 MG RxCUI 857702 potassium 50 MG RxCUI 855942
  11. Dose form (SCDF) Powder for Oral Solution RxCUI 1856554 In current FDA listings
    Clinical drug / strength (SCD) potassium 50 MG RxCUI 859063
  12. Dose form (SCDF) Rectal Suppository RxCUI 371796 No current FDA listing
    Clinical drug / strength (SCD) sodium 100 MG RxCUI 857696 sodium 12.5 MG RxCUI 857698 sodium 25 MG RxCUI 857703 sodium 50 MG RxCUI 857709
  13. Dose form (SCDF) Topical Cream RxCUI 438948 In current FDA listings
    Clinical drug / strength (SCD) sodium 10 MG/ML RxCUI 1043479
  15. Dose form (SCDF) Topical Solution RxCUI 393139 In current FDA listings
    Clinical drug / strength (SCD) sodium 15 MG/ML RxCUI 857700 sodium 20 MG/ML RxCUI 1487074

Look up RxCUI 3355 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.

Diclofenac brand names

Diclofenac is sold under 16 brand names in the FDA directory — Cambia, Zipsor, Zorvolex, Cataflam and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Cambia Zipsor Zorvolex Cataflam Voltaren XR Surpass Anti-Inflammatory Pennsaid Licart Aleve Arthritis Pain Lofena Xiclo Flector Voltaren Arthritis Pain Reliever diclofenac epolamine arthritis pain relieving

Who makes Diclofenac: manufacturers and labelers

40 companies list Diclofenac products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, Preferred Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 66 A-S Medication Solutions 56 Preferred Pharmaceuticals Inc. 41 Remedyrepack Inc. 41 Proficient Rx LP 40 Advanced Rx Pharmacy of Tennessee, LLC 37 NuCare Pharmaceuticals,Inc. 32 Quality Care Products, LLC 20 Asclemed USA, Inc. 19 Direct_Rx 16 Advagen Pharma Ltd 16 Golden State Medical Supply, Inc. 14 PD-Rx Pharmaceuticals, Inc. 14 Advanced Rx of Tennessee, LLC 13 Phoenix Rx Llc 12 AvKARE 10 Direct Rx 10 Actavis Pharma, Inc. 9 RedPharm Drug, Inc. 9 St. Mary's Medical Park Pharmacy 9 NuCare Pharmaceuticals, Inc. 9 Carlsbad Technology, Inc. 8 Lake Erie Medical DBA Quality Care Products LLC 8 Aurohealth LLC 8

…and 16 more on the FDA NDC directory.

Diclofenac drug class (RxNorm)

Diclofenac belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other dermatologicals, Acetic acid derivatives and related substances, 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 Diclofenac 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 Dec 1, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Diclofenac.
📈
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 Diclofenac after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
226
NDC products indexed
1,027
Distinct labelers/manufacturers represented
226
Linked representative label ⓘ
Proficient Rx LP
Linked label effective
Dec 1, 2023
Composite sections available
24
Linked SPL Set ID
f19bf286-f4dd-4491-90c3-9f8713071903
Linked SPL Document ID
f19bf286-f4dd-4491-90c3-9f8713071903
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. Proficient Rx LP 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 →