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Diclofenac Topical (actinic keratosis)

Diclofenac sodium topical gel is a prescription anti-inflammatory gel applied directly to the skin to relieve joint pain from osteoarthritis of the hands and knees.

Brand names Solaraze GelSurpass Anti-InflammatoryZorvolexPennsaidLicart +8 more
Drug class Nonsteroidal Anti-inflammatory Drug
Rx
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 8, 2026
🧬 Where this information comes from

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set 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 →

✓No current FDA shortage listed · checked Oct 9, 2026 🚨Recall on record · 3
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Diclofenac topical gel is a prescription NSAID (nonsteroidal anti-inflammatory drug) rubbed over osteoarthritis joints near the skin, like the knees and hands, where it blocks the COX enzyme that makes prostaglandins, the messengers behind pain and swelling. It is often a first choice for these joints because far less drug reaches the bloodstream than with NSAIDs taken by mouth. Most people tolerate it well, and what they notice is redness, itching, dryness or a rash where the gel goes on. Still, it carries the boxed warning all NSAIDs share for heart attack, stroke and serious stomach bleeding, so get help for chest pain or black, tarry stools.

Clinical pearls

  • Use the smallest amount that works, measured on the dosing card, and never exceed the daily limit per joint or overall.
  • Wait an hour before washing treated hands, and skip the spine, hips and shoulders, where it was not studied.
  • Adding a blood thinner or aspirin raises the stomach bleeding risk, and it can push up lithium levels and methotrexate toxicity.
  • It can blunt water pills and ACE inhibitors and, with a water pill, strain the kidneys, so your prescriber should know.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

This medication carries the FDA's most serious warning. NSAIDs like diclofenac can increase the risk of heart attack and stroke — both of which can be fatal. This risk can grow with longer use and is higher in people who already have heart or blood vessel disease. Separately, NSAIDs can cause serious stomach and intestinal bleeding, ulcers, or perforation — also potentially fatal — and these can happen at any time, even without stomach pain as a warning sign. Older adults face a higher risk of these GI complications. This gel must not be used around the time of heart bypass (CABG) surgery.

Read the full warning on DailyMed →
How you get itPrescription only
Earliest FDA record1988
FDA label last updatedNov 1, 2019
FDA’s strongest warning (boxed)Yes, read the warning

Patient Information Guide A plain-language walkthrough of Diclofenac Topical (actinic keratosis), written from its FDA label.

What Diclofenac Topical (actinic keratosis) Is Used For

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Diclofenac sodium topical gel is used to relieve pain from osteoarthritis in joints near the skin's surface:

  • Knees
  • Hands and fingers
  • Feet and toes
  • Ankles
  • Wrists
  • Elbows

How Diclofenac Topical (actinic keratosis) Works

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Diclofenac blocks an enzyme called cyclooxygenase (COX), which your body needs to produce prostaglandins — the chemical signals that trigger pain, swelling, and inflammation in joints. By reducing prostaglandin production, diclofenac helps calm the inflammation that makes arthritic joints hurt. It also has mild fever-reducing and pain-dampening effects throughout the body.

Diclofenac Topical (actinic keratosis) Dosage

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The gel is applied to the skin over the affected joint and rubbed in gently, four times a day. A dosing card is included in the carton to help you measure the correct amount — different joints require different amounts, so always use the card. There are daily limits per joint and for total use across all joints; do not exceed them.

  • Lower extremity joints (knee, ankle, foot): apply a larger measured amount four times daily
  • Upper extremity joints (hand, wrist, elbow): apply a smaller measured amount four times daily
  • If treating your hands, wait at least one hour before washing them
  • Rinse and dry the dosing card after each use

Dosing details from the FDA-approved label

From the Diclofenac Topical (actinic keratosis) 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.

Total dose should not exceed 32 g per day, over all affected joints.

Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Total dose should not exceed 32 g per day, over all affected joints. ( 2.3 ) Diclofenac sodium topical gel should be measured onto the enclosed dosing card to the appropriate 2 g or 4 g designation. ( 2 ) • Lower extremities: Apply the gel (4 g) to the affected area 4 times daily. Do not apply more than 16 g daily to any one affected joint of the lower extremities. ( 2.2 ) • Upper extremities: Apply the gel (2 g) to the affected area 4 times daily. Do not apply more than 8 g daily to any one affected joint of the upper extremities. ( 2.3 ) 2.1 Dosing Card [See the patient Instructions for Use] The dosing card can be found attached to the inside of the carton. The proper amount of diclofenac sodium topical gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of clear polypropylene. The dosing card should be used for each application of drug product. The gel should be applied within the rectangle area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The 2 g line is 2.25 inches long. The 4 g line is 4.5 inches long. The dosing card containing diclofenac sodium topical gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. If treatment site is the hands, patients should wait at least one (1) hour to wash their hands. 2.2 Lower extremities, including the knees, ankles, and feet Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Diclofenac sodium topical gel should be gently massaged into the skin ensuring application to the entire affected foot, or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities. 2.3 Upper extremities including the elbows, wrists, and hands Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Diclofenac sodium topical gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.

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

Diclofenac Topical (actinic keratosis) Side Effects

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The most common side effects are local skin reactions at the spot where you apply the gel:

Common side effects

  • Skin irritation or redness at the application site
  • Contact dermatitis (a rash or skin reaction where the gel is applied)
  • Dry or flaking skin at the treated area
  • Itching at the application site
  • Skin discoloration at the treated area

When to get medical help

  • Chest pain, shortness of breath, sudden weakness, or slurred speech — possible signs of a heart attack or stroke
  • Stomach pain, black or tarry stools, or vomiting blood — possible signs of serious GI bleeding
  • Sudden swelling of the face, lips, tongue, or throat, or trouble breathing — signs of a severe allergic reaction
  • Yellowing of skin or eyes, unusual tiredness, or dark urine — possible signs of liver problems
  • Significant swelling of the legs, ankles, or feet — may signal fluid retention or heart/kidney issues
  • New or worsening rash, blistering, or skin peeling — stop use and call your doctor

Stop using the gel and get medical help right away if you develop chest pain, signs of stomach bleeding (black stools, vomiting blood), difficulty breathing, severe swelling, or a spreading skin rash — these can be signs of a serious reaction that needs immediate attention.

Diclofenac Topical (actinic keratosis) Warnings and Precautions

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  • Heart attack and stroke: NSAIDs can increase the risk of serious cardiovascular events, even with short-term use. People with heart disease or high blood pressure face higher risk.
  • Stomach and intestinal bleeding: Serious GI bleeding or ulcers can occur without any warning symptoms. Older adults are at the greatest risk.
  • Kidney problems: Long-term use can injure the kidneys, especially in older adults, those with existing kidney issues, heart failure, or liver disease, and those taking diuretics or ACE inhibitors.
  • Liver effects: Liver enzyme levels may rise during treatment. Stop using the gel if you develop symptoms of liver problems (yellowing of skin/eyes, unusual fatigue, dark urine).
  • High blood pressure and fluid retention: NSAIDs can raise blood pressure and cause swelling. Monitor blood pressure during treatment.
  • Severe skin reactions: Rare but potentially fatal skin conditions (such as Stevens-Johnson Syndrome) have been reported with NSAIDs. Stop using if a serious rash or blistering develops.
  • Severe allergic reactions: People who have had asthma, hives, or other reactions to aspirin or NSAIDs should not use this gel.

Diclofenac Topical (actinic keratosis) Interactions

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Diclofenac topical gel can interact with several common medications — always share your full medication list with your prescriber:

  • Aspirin: Combining the two raises the risk of stomach bleeding and is generally not recommended
  • Blood thinners (e.g., warfarin): The combination significantly increases the risk of serious GI bleeding
  • ACE inhibitors (blood pressure drugs): Diclofenac may reduce their blood-pressure-lowering effect
  • Diuretics (water pills): Diclofenac can blunt their effectiveness and put extra strain on the kidneys
  • Lithium: Diclofenac can raise lithium blood levels, increasing the risk of lithium toxicity
  • Methotrexate: Diclofenac may increase the toxic effects of this medication

Interactions listed in the FDA-approved label

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

7 DRUG INTERACTIONS. Concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects including increased GI bleeding.

Read the label’s full interactions text

7 DRUG INTERACTIONS • Concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects including increased GI bleeding. ( 7.1 ) • Concomitant use of anticoagulants and diclofenac have a risk of serious GI bleeding higher than users of either drug alone. ( 7.2 ) 7.1 Aspirin When diclofenac is administered with aspirin, the binding of diclofenac to protein is reduced, although the clearance of free diclofenac is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects. 7.2 Anticoagulants The effects of anticoagulants such as warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. 7.3 ACE-Inhibitors NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors. 7.4 Diuretics Clinical studies, as well as post-marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. The response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure [see Warnings and Precautions (5.6)] , as well as to assure diuretic efficacy. 7.5 Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID.

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.

Check Diclofenac Topical (actinic keratosis) against a supplement or herb →

Before Taking Diclofenac Topical (actinic keratosis)

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  • Do not use if you are allergic to diclofenac, aspirin, or any other NSAID
  • Do not use if you have ever had asthma, hives, or a serious allergic reaction triggered by aspirin or NSAIDs
  • Do not use around the time of coronary artery bypass graft (CABG) heart surgery
  • Tell your doctor if you have heart disease, prior stroke, or risk factors such as high blood pressure or high cholesterol
  • Tell your doctor if you have a history of stomach ulcers or GI bleeding
  • Tell your doctor if you have kidney or liver disease, or heart failure
  • Avoid during late pregnancy — it can cause premature closure of an important blood vessel in the baby's heart
  • Use with caution if breastfeeding; discuss the risks and benefits with your doctor
  • Safety and effectiveness have not been established in children
  • Older adults should use with extra caution due to higher risk of GI and kidney complications

Diclofenac Topical (actinic keratosis) Overdose

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If the gel is accidentally swallowed in significant amounts, it can cause symptoms similar to taking too much of an NSAID pill — including nausea, vomiting, stomach pain, drowsiness, and in serious cases, GI bleeding, high blood pressure, or kidney problems. If this happens, call Poison Control at 1-800-222-1222 right away or seek emergency care.

What Diclofenac Topical (actinic keratosis) Does in the Body

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Diclofenac has three main effects on the body: it reduces inflammation, relieves pain (anti-nociception means it dulls the body's pain signals), and lowers fever. These effects all stem from its ability to reduce the production of prostaglandins, the chemical messengers that amplify inflammation, pain sensitivity, and elevated body temperature.

How Your Body Processes Diclofenac Topical (actinic keratosis)

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When applied to the skin as a gel, diclofenac is absorbed through the skin but reaches the bloodstream at dramatically lower levels than oral diclofenac — on average about 17 times less drug in the body compared to taking the equivalent oral dose. This means the gel acts mainly at the local joint level rather than throughout the whole body. Heat or exercise at the application site may affect how the drug is absorbed, so avoid applying heat patches immediately before using the gel.

How to Store Diclofenac Topical (actinic keratosis)

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Store at 20°C to 25°C (68°F to 77°F). Store the dosing card with your diclofenac sodium topical gel.

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

Diclofenac Topical (actinic keratosis): Pharmacist Answers to Common Questions

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

Is this gel the same as taking an NSAID pill like ibuprofen?

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It's the same class of medicine, but the gel works mostly at the joint where you apply it. Because very little of the drug actually enters your bloodstream — about 17 times less than an equivalent oral dose — you get targeted relief with less whole-body exposure. That said, the same serious risks (heart, stomach, kidney) that come with NSAID pills still apply, even in smaller amounts, so it's not completely risk-free.

How do I actually use the dosing card that comes in the box?

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The dosing card lets you measure the right amount of gel before each application. You squeeze the gel onto the card up to the marked line — there's a shorter line for hand, wrist, or elbow, and a longer line for knee, ankle, or foot. Then use the card or your hands to rub the gel gently into the entire surface of the affected joint. Rinse and dry the card after every use. If you're treating your hands, wait at least an hour before washing them so the gel has time to absorb.

What side effects should I just watch for versus ones that mean I need to call someone right away?

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The most common side effects are local skin reactions where you apply the gel — redness, mild rash, dryness, or itching. Those are usually manageable. But call your doctor or get emergency help right away for chest pain, sudden weakness or slurred speech, vomiting blood or black tarry stools, significant swelling, or trouble breathing. A severe spreading rash or blistering skin is also a reason to stop the gel immediately and seek care.

I already take a blood thinner and a water pill — is it safe to use this gel?

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You'll want to flag this with your prescriber before starting. Diclofenac can boost the bleeding risk of blood thinners like warfarin significantly, and it can also reduce how well diuretics (water pills) work while putting extra strain on your kidneys. Your doctor may still decide the gel is right for you, but they'll want to monitor you more closely.

Can I use this if I'm pregnant or breastfeeding?

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In late pregnancy especially, this gel should be avoided — NSAIDs can cause a blood vessel in the baby's heart to close too early, which is a serious problem. There's no well-controlled safety data during pregnancy overall. If you're breastfeeding, the potential for the drug to pass into breast milk can't be ruled out, so talk to your doctor about whether to pause breastfeeding or find an alternative treatment.

Can I put this gel on my hip or back?

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No — this gel hasn't been studied for the spine, hip, or shoulder, so it's only approved for joints you can reach near the surface of the skin, like your knees and hands. Using it on areas it hasn't been tested on isn't recommended. If you're dealing with hip or back pain from arthritis, ask your doctor about other options.

Is Diclofenac Topical (actinic keratosis) available over the counter?

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No. Diclofenac Topical (actinic keratosis) is a prescription medicine: every Diclofenac Topical (actinic keratosis) product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Diclofenac Topical (actinic keratosis) first available?

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The earliest FDA record we hold for Diclofenac Topical (actinic keratosis) is from 1988: 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 Topical (actinic keratosis) was first used.

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

More About Diclofenac Topical (actinic keratosis) on HelloPharmacist

🌿Drug & Supplement CheckerDiclofenac Topical (actinic keratosis) vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Diclofenac Topical (actinic keratosis) NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed Data & References for Diclofenac Topical (actinic keratosis) 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 Topical (actinic keratosis) on the U.S. Market: Products, Makers and Brands

How Diclofenac Topical (actinic keratosis) 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.

The FDA lists Diclofenac Topical (actinic keratosis) products; the earliest marketing or approval year on record is 1988. Brand names on the directory include Solaraze Gel, Surpass Anti-Inflammatory, Zorvolex and 10 more; the rest are generics.

1988
Earliest FDA record ⓘ

How Widely Diclofenac Topical (actinic keratosis) Is Used (Medicaid Data)

A general measure of how commonly Diclofenac Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) prescribed? Of the 1,603 medications we measure, Diclofenac Topical (actinic keratosis) ranks #44 by Medicaid prescriptions — more than 97% of them.

Where Diclofenac Topical (actinic keratosis) ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #44 of 1,603
#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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Topical (actinic keratosis), 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 Topical (actinic keratosis) NDCs with Medicaid activity.

Diclofenac Topical (actinic keratosis) 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 Oct 8, 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 Topical (actinic keratosis) 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 No current FDA listing
    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 No current FDA listing
    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 No current FDA listing
    Clinical drug / strength (SCD) sodium 1 MG/ML RxCUI 854801
  8. Dose form (SCDF) Oral Capsule RxCUI 376352 No current FDA listing
    Clinical drug / strength (SCD) 18 MG RxCUI 1442116 25 MG RxCUI 858342 35 MG RxCUI 1442128
  9. Dose form (SCDF) Oral Solution RxCUI 393225 No current FDA listing
    Clinical drug / strength (SCD) sodium 0.25 MG/ML RxCUI 857689
  10. Dose form (SCDF) Oral Tablet RxCUI 371798 No current FDA listing
    Clinical drug / strength (SCD) potassium 25 MG RxCUI 857702 potassium 50 MG RxCUI 855942
  11. Dose form (SCDF) Powder for Oral Solution RxCUI 1856554 No current FDA listing
    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 No current FDA listing
    Clinical drug / strength (SCD) sodium 10 MG/ML RxCUI 1043479
  15. Dose form (SCDF) Topical Solution RxCUI 393139 No current FDA listing
    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 Topical (actinic keratosis) Brand Names

Diclofenac Topical (actinic keratosis) is sold under 13 brand names in the FDA directory — Solaraze Gel, Surpass Anti-Inflammatory, Zorvolex, Pennsaid and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Solaraze Gel Surpass Anti-Inflammatory Zorvolex Pennsaid Licart Aleve Arthritis Pain Lofena Xiclo Flector Voltaren Cataflam Zipsor Cambia

Diclofenac Topical (actinic keratosis) Drug Class (RxNorm)

Diclofenac Topical (actinic keratosis) 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 Topical (actinic keratosis) 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 Nov 1, 2019
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Diclofenac Topical (actinic keratosis).
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Diclofenac Topical (actinic keratosis) after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Linked representative label ⓘ
Proficient Rx LP
Linked label effective
Nov 1, 2019
Composite sections available
24
Linked SPL Set ID
a7447467-79e0-436e-a273-d1ddd06169cf
Linked SPL Document ID
b7cca998-edc7-40b5-bc62-b789921ad6c8
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 →