Diclofenac
Diclofenac sodium topical gel is a prescription anti-inflammatory gel applied to the skin to treat actinic keratoses — rough, scaly patches caused by sun damage that can become skin cancer.
🧬 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
This medication carries the FDA's most serious warning — a boxed warning — about two major risks:
Heart risk: Like all NSAIDs, diclofenac gel can raise the chance of a serious cardiovascular event — including heart attack or stroke — which can be fatal. This risk can happen early in treatment and may grow the longer it is used. This gel must not be used around the time of coronary artery bypass graft (CABG) heart surgery.
Stomach and intestinal bleeding: NSAIDs can cause serious bleeding, ulcers, or even perforation (a hole) in the stomach or intestines. These problems can occur at any time, even without any warning signs. Older adults and anyone with a history of stomach ulcers or GI bleeding are at the greatest risk. Seek medical attention immediately if you notice stomach pain, bloody or black stools, or vomiting blood.
📖 Diclofenac: Patient Information Guide
A plain-language walkthrough of Diclofenac — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Diclofenac sodium topical gel is prescribed to treat precancerous skin patches known as actinic keratoses. Here's what that means:
- Actinic keratoses (AK) — rough, scaly skin patches caused by long-term sun exposure that have the potential to develop into skin cancer
💊How it's taken▾
This gel is applied directly to the skin — not taken by mouth. Use a pea-sized amount on each affected area and gently smooth it in to fully cover the lesion. Apply it twice a day for the full treatment course of 60 to 90 days.
- Keep it away from your eyes, nose, and mouth
- Never apply to broken, burned, or infected skin
- After finishing treatment, allow up to 30 more days for full healing to appear
- If a lesion doesn't improve, talk to your prescriber — it may need to be re-evaluated
Always use the smallest amount that works for the shortest time needed, and follow your prescriber's specific guidance.
🤒Side effects — in detail▾
The most common side effects happen right where you apply the gel:
- Redness, itching, or irritation at the application site
- Contact dermatitis (an inflammatory skin reaction)
- Dry skin
- Flaking or peeling (exfoliation)
- Skin rash
Most of these are mild to moderate and get better once treatment stops. However, if you develop a severe skin reaction, signs of a serious allergic response (swelling, trouble breathing), stomach pain, black stools, chest pain, or yellowing of the skin — stop using the gel and seek medical attention right away.
⚠️Warnings & precautions▾
- Heart attack and stroke: NSAIDs raise the risk of serious cardiovascular events, which can be fatal — even early in treatment. Risk increases with longer use.
- GI bleeding and ulcers: Serious stomach or intestinal bleeding can happen without any warning signs. Older adults and those with a history of ulcers are most at risk.
- Severe allergic reactions: Anaphylaxis (a life-threatening allergic reaction) has occurred — get emergency help immediately if this happens.
- Liver damage: Watch for signs like yellowing of the skin or eyes, dark urine, or unusual fatigue. Discontinue and see your doctor if these appear.
- Kidney problems: Especially in people who are dehydrated, have heart failure, or existing kidney or liver disease.
- Pregnancy risks: Avoid after week 30 of pregnancy; limit use between weeks 20–30. Can cause serious harm to the developing baby.
- Photosensitivity: Avoid sunlight and tanning lamps on treated skin areas during treatment.
- DRESS: A rare but serious reaction involving rash, fever, and internal organ involvement — stop use and seek care if this develops.
🔀What it interacts with▾
Diclofenac gel can interact with several common medications, so it's important your doctor knows everything you take:
- Warfarin and other anticoagulants (blood thinners): Risk of serious bleeding increases significantly
- Aspirin at pain-relieving doses: Raises GI bleeding risk; this gel does not replace low-dose aspirin for heart protection
- SSRIs/SNRIs (antidepressants like sertraline or duloxetine): May further increase bleeding risk
- ACE inhibitors, ARBs, beta-blockers (blood pressure medicines): May reduce their effectiveness; kidney risk increases in vulnerable patients
- Diuretics (water pills like furosemide): NSAIDs can blunt their effects and stress the kidneys
- Other oral NSAIDs (ibuprofen, naproxen): Avoid combining — higher chance of side effects
- Lithium: NSAIDs can push lithium levels higher, increasing toxicity risk
- Methotrexate: NSAIDs can increase methotrexate toxicity
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Tell your doctor if you have ever had an allergic reaction — including hives, asthma, or anaphylaxis — after taking aspirin or any other NSAID
- Do not use if you are having or recently had CABG (coronary artery bypass graft) heart surgery
- Do not apply to skin that is damaged, infected, burned, or affected by eczema or open wounds
- Tell your doctor if you have heart disease, high blood pressure, a history of stroke, or kidney or liver problems
- Tell your doctor if you have a history of stomach ulcers or GI bleeding — the risk of serious bleeding is higher for you
- Older adults face greater risk of GI bleeding — discuss this with your prescriber
- If you are pregnant or planning to become pregnant, talk to your doctor — this medication can harm the baby, especially after week 20 of pregnancy
- If you are trying to get pregnant, be aware that NSAIDs may temporarily affect fertility — ask your doctor whether to pause treatment
🚑If you take too much▾
If someone swallows diclofenac gel accidentally, symptoms can include drowsiness, nausea, vomiting, and stomach pain. In more serious cases, GI bleeding, high blood pressure, kidney problems, or breathing difficulties have been reported.
There is no specific antidote. If accidental ingestion occurs, call Poison Control right away at 1-800-222-1222 for guidance. Medical treatment is supportive — managing symptoms as they arise.
🔬Pharmacokinetics — how your body processes it▾
Because this is a topical gel, only a very small amount of diclofenac is absorbed into the bloodstream — blood levels stay very low (on average at or below 20 ng/mL after twice-daily use over several months). Once absorbed, diclofenac binds tightly to a blood protein called serum albumin.
The drug is broken down (metabolized) into several byproducts, most of which are then processed further and excreted mainly in the urine. The metabolism after skin application is thought to work similarly to how the body handles oral diclofenac, though the small amounts involved make precise measurement difficult.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F) . Protect from heat. Avoid freezing.
📄 Written from Diclofenac’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
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.
- Major · 7
- Moderate · 266
- Minor · 35
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.
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.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
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 exactly is an actinic keratosis, and why do I need a prescription gel for it? ▾
How long do I need to use this gel, and how will I know it's working? ▾
Is it safe if only a tiny amount gets absorbed through my skin? ▾
Can I go out in the sun while I'm using this gel? ▾
I take ibuprofen sometimes for headaches — is that okay while using this gel? ▾
I'm pregnant — is this gel safe to use? ▾
Is Diclofenac available over the counter? ▾
When was Diclofenac first available? ▾
Who makes Diclofenac? ▾
💬 Answers drafted from Diclofenac’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Diclofenac 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
Show 1 more strength Show fewer strengths
Delayed-release tablet
Topical solution
Tablet
Skin patch
Extended-release tablet
Capsule
Oral solution
Eye drops
📊 Diclofenac across the U.S. market
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.
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.
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
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.
How commonly is Diclofenac prescribed? Of the 1,596 medications we measure, Diclofenac ranks #44 by Medicaid prescriptions — more than 97% of them.
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.
diclofenac sodium 0.01 MG/MG Topical Gel Most dispensed
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
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
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
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
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
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
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
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
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
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
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
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
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
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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 25 mg | Oral | Assertio Therapeutics, Inc. × 2 listings | NDA | View NDC → |
| 25 mg | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 25 mg | — | Aurobindo Pharma Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 25 mg | Oral | Avet Pharmaceuticals Inc | ANDA | View NDC → |
| 25 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 25 mg | Oral | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | View NDC → |
| 25 mg | — | Catalent Ontario Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 35 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 35 mg | — | Catalent Pharma Solutions, LLC | EXPORT ONLY | View NDC → |
| 25 mg | Oral | Chartwell RX, LLC × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | INA Pharmaceutics Inc. × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Leading Pharma, LLC × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 25 mg | Oral | Lifsa Drugs LLC | ANDA | View NDC → |
| 25 mg | — | Patheon Softgels Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 25 mg | Oral | PureTek Corporation | ANDA | View NDC → |
| 25 mg | Oral | Strides Pharma Science Limited × 4 listings | ANDA | View NDC → |
| 25 mg | Oral | Teva Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Trifluent Pharma LLC | ANDA | View NDC → |
| 35 mg | Oral | TriVue Pharmaceuticals, Inc. | NDA | Find on DailyMed ↗ |
| 18 mg | Oral | Zyla Life Sciences US Inc. | NDA | View NDC → |
| 35 mg | Oral | Zyla Life Sciences US Inc. | NDA | View NDC → |
| 💊Topical cream, ointment or gel | ||||
| 10 mg/g | Topical | A-S Medication Solutions × 10 listings | ANDA | View NDC → |
| 10 mg/g | Topical | A-S Medication Solutions | NDA | View NDC → |
| 10 mg/g | Topical | A-S Medication Solutions × 2 listings | NDA AUTHORIZED GENERIC | Find on DailyMed ↗ |
| 30 mg/g | Topical | Actavis Pharma, Inc. × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Advanced Rx Pharmacy of Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 30 mg/g | Topical | Advanced Rx Pharmacy of Tennessee, LLC × 8 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Akorn | ANDA | View NDC → |
| 30 mg/g | Topical | Alembic Pharmaceuticals, Inc. | ANDA | View NDC → |
| 30 mg/g | Topical | Alembic Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 30 mg/g | Topical | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg/g | Topical | Amazon.com Services LLC × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | American Sales Company × 2 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Amerisource Bergen × 2 listings | ANDA | View NDC → |
| 10 mg/g | Topical | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA | View NDC → |
| 10 mg/g | Topical | Amneal Pharmaceuticals LLC × 2 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Amneal Pharmaceuticals NY LLC × 2 listings | ANDA | View NDC → |
| 30 mg/g | Topical | Amneal Pharmaceuticals of New York LLC × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Asclemed USA, Inc. | ANDA | View NDC → |
| 30 mg/g | Topical | Asclemed USA, Inc. × 4 listings | ANDA | View NDC → |
| 30 mg/g | Topical | Asclemed Usa Inc. | ANDA | View NDC → |
| 10 mg/g | Topical | Atlantic Biologicals Corp. | ANDA | Find on DailyMed ↗ |
| 10 mg/g | Topical | Aurobindo Pharma Limited | ANDA | View NDC → |
| 10 mg/g | Topical | Aurohealth LLC × 6 listings | ANDA | View NDC → |
| 10 mg/g | Topical | AvKARE | ANDA | View NDC → |
| 10 mg/g | Topical | AvPAK | ANDA | Find on DailyMed ↗ |
| 1 mg/g | Topical | Bayer HealthCare LLC × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Best Choice (Valu Merchandisers Company) × 2 listings | ANDA | View NDC → |
| 10 mg/g | — | Bora Pharmaceutical Services Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 10 mg/g | Topical | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 30 mg/g | Topical | Bryant Ranch Prepack × 5 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Cardinal Health (Leader) 70000 × 2 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Cardinal Health 110, Llc. Dba Leader 70000 | ANDA | View NDC → |
| 10 mg/g | Topical | Care One (Retail Business Services, LLC.) × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Chain Drug Consortium, LLC × 3 listings | ANDA | View NDC → |
| 0.01 g/g | Topical | Chattem, Inc. × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Cipla USA Inc. × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Costco Wholesale × 2 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Costco Wholesale Company × 4 listings | ANDA | View NDC → |
| 10 mg/g | Topical | CVS Pharmacy × 6 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Cvs Pharmacy, Inc × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Cvs Woonsocket Prescription Center, Incorporated × 2 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Direct_Rx × 2 listings | ANDA | View NDC → |
| 30 mg/g | Topical | Direct_Rx × 6 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Dolgencorp, LLC | ANDA | View NDC → |
| 10 mg/g | Topical | Dolgencorp Inc × 2 listings | ANDA | View NDC → |
| 10 mg/g | Topical | EQUATE (Wal-Mart Stores, Inc.) | ANDA | View NDC → |
| 10 mg/g | Topical | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) × 2 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Exelan Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Family Dollar (FAMILY WELLNESS) × 2 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Galloping LLC | ANDA | View NDC → |
| 10 mg/g | Topical | Geri-care Pharmaceutical Corp × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC × 2 listings | NDA | View NDC → |
| 30 mg/g | Topical | Glenmark Pharmaceuticals Inc., Usa × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Haleon US Holdings LLC | NDA | View NDC → |
| 10 mg/g | Topical | Harris Teeter | ANDA | View NDC → |
| 10 mg/g | Topical | Harris Teeter, LLC × 2 listings | ANDA | View NDC → |
| 30 mg/g | Topical | Hawaii Repack, Inc | ANDA | View NDC → |
| 10 mg/g | Topical | H E B × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Hisamitsu America, Inc. × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | HyVee Inc | ANDA | View NDC → |
| 10 mg/g | Topical | Innovus Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg/g | Topical | Innovus Pharmaceuticals Inc. | ANDA | View NDC → |
| 30 mg/g | Topical | Ipg Pharmaceuticals, Inc. | ANDA | View NDC → |
| 9.3 mg/g | Topical | Johnson & Johnson Consumer Inc. | ANDA | View NDC → |
| 9.3 mg/g | Topical | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | View NDC → |
| 9.3 mg/g | Topical | Kenvue Brands LLC | ANDA | View NDC → |
| 10 mg/g | Topical | Kroger Company | ANDA | View NDC → |
| 10 mg/g | Topical | L. Perrigo Company × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Lake Erie Medical DBA Quality Care Products LLC × 2 listings | ANDA | View NDC → |
| 30 mg/g | Topical | Lake Erie Medical DBA Quality Care Products LLC × 2 listings | ANDA | View NDC → |
| 10 mg/g | Topical | LifeMD | ANDA | View NDC → |
| 1 g/100 g | Topical | Little Pharma, Inc. × 3 listings | ANDA | View NDC → |
| 30 mg/g | Topical | Medsource Pharmaceuticals | ANDA | View NDC → |
| 10 mg/g | Topical | Meijer Distribution Inc × 2 listings | ANDA | View NDC → |
Showing 200 of 1,012 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1,012 Diclofenac NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Diclofenac — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Diclofenac in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Diclofenac went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 3355 15 dose forms · 30 strengths
-
Dose form (SCDF) Delayed Release Oral Capsule RxCUI 438955No current FDA listingClinical drug / strength (SCD) sodium 25 MGRxCUI 1234844sodium 50 MGRxCUI 1234853 -
Dose form (SCDF) Delayed Release Oral Tablet RxCUI 371794In current FDA listingsClinical drug / strength (SCD) sodium 25 MGRxCUI 855664sodium 50 MGRxCUI 855906sodium 75 MGRxCUI 855926 -
Dose form (SCDF) Extended Release Oral Capsule RxCUI 371793No current FDA listingClinical drug / strength (SCD) 24 HR diclofenac sodium 100 MGRxCUI 41184624 HR diclofenac sodium 75 MGRxCUI 411848 -
Dose form (SCDF) Extended Release Oral Tablet RxCUI 371799In current FDA listingsClinical drug / strength (SCD) sodium 75 MGRxCUI 85771324 HR diclofenac sodium 100 MGRxCUI 855657 -
Dose form (SCDF) Injectable Solution RxCUI 371795No current FDA listingClinical drug / strength (SCD) sodium 25 MG/MLRxCUI 857705 -
Dose form (SCDF) Medicated Patch RxCUI 1792846In current FDA listingsClinical drug / strength (SCD) Once-Daily diclofenac epolamine 0.013 MG/MGRxCUI 2385117Twice-Daily diclofenac epolamine 0.013 MG/MGRxCUI 8556260.0125 MG/MGRxCUI 2705052 -
Dose form (SCDF) Ophthalmic Solution RxCUI 378986In current FDA listingsClinical drug / strength (SCD) sodium 1 MG/MLRxCUI 854801 -
Dose form (SCDF) Oral Capsule RxCUI 376352In current FDA listings -
Dose form (SCDF) Oral Solution RxCUI 393225In current FDA listingsClinical drug / strength (SCD) sodium 0.25 MG/MLRxCUI 857689 -
Dose form (SCDF) Oral Tablet RxCUI 371798In current FDA listings -
Dose form (SCDF) Powder for Oral Solution RxCUI 1856554In current FDA listingsClinical drug / strength (SCD) potassium 50 MGRxCUI 859063 -
Dose form (SCDF) Rectal Suppository RxCUI 371796No current FDA listingClinical drug / strength (SCD) sodium 100 MGRxCUI 857696sodium 12.5 MGRxCUI 857698sodium 25 MGRxCUI 857703sodium 50 MGRxCUI 857709 -
Dose form (SCDF) Topical Cream RxCUI 438948In current FDA listingsClinical drug / strength (SCD) sodium 10 MG/MLRxCUI 1043479 -
Dose form (SCDF) Topical Gel RxCUI 377959In current FDA listings -
Dose form (SCDF) Topical Solution RxCUI 393139In current FDA listings
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.
📦 Supply & shortage status
Whether Diclofenac is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
…and 16 more on the FDA NDC directory.
RxNorm drug class
Diclofenac belongs to the Nonsteroidal Anti-inflammatory Drug class.
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.
🔬 Where this comes from
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 226 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Proficient Rx LP is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.