FDA-filed SPL labeling · retrieved through openFDA

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.

Brand names CambiaZipsorZorvolexCataflamVoltaren XR +11 more
Drug class Nonsteroidal Anti-inflammatory Drug
Rx/OTC Forms 9 Routes Topical · Oral · Ophthalmic · Transdermal
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 →

At a glance
Linked label effectiveDec 1, 2023
Clinical labels in scope 226
AvailabilityRx/OTC
Earliest approval/marketing year 1980
FDA-listed product records 1,012
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026 🚨Recall on record · 3
Other forms & routes:
Diclofenac at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Diclofenac sodium topical gel is an effective option for treating precancerous sun-damaged skin patches, but it carries real risks — especially for the heart and stomach — that your doctor needs to weigh for your situation. Use only the amount directed, only for as long as recommended, protect treated skin from the sun, and report any unusual symptoms promptly. Follow up with your prescriber, since some areas may need re-evaluation if they don't respond.
⚠️ 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.

Read the full warning on DailyMed →

📖 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 →

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
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.

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.

🩺 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?
An actinic keratosis — often just called an AK — is a rough, scaly patch on the skin caused by years of sun exposure. These patches are considered precancerous, meaning they could eventually turn into a type of skin cancer called squamous cell carcinoma if left untreated. This gel is prescribed to help treat those patches directly on the skin so they hopefully don't progress. It's one tool your dermatologist may recommend, and it's worth following through with the full treatment course even if you don't notice dramatic changes right away.
How long do I need to use this gel, and how will I know it's working?
The typical treatment course runs 60 to 90 days of twice-daily application — that's a solid commitment, but it's necessary for the gel to do its job. Here's the thing: even after you stop applying it, your skin can continue to improve for up to 30 more days. So don't panic if you finish treatment and still see some roughness — give it another month. If a patch doesn't respond at all, let your doctor know, because it may need a closer look or a different treatment approach.
Is it safe if only a tiny amount gets absorbed through my skin?
Yes, blood levels from this gel are very low — much lower than what you'd get from taking an NSAID pill. That said, even small absorbed amounts carry some of the same risks as oral NSAIDs, including rare but serious heart and stomach effects. This is why the gel comes with the same boxed warning as oral NSAIDs. If you have heart disease, a history of stomach ulcers, or kidney problems, make sure your doctor knows before using this gel — the risk is still real even if it's smaller.
Can I go out in the sun while I'm using this gel?
You need to be careful. This gel can make treated skin more sensitive to sunlight, which could cause a reaction or irritation in the areas you're applying it. While you're on treatment, try to avoid direct sun exposure and artificial UV light — like tanning beds — on those specific areas. Protective clothing and staying in the shade are your best friends here. Check with your doctor or pharmacist about the best way to protect your skin during treatment.
I take ibuprofen sometimes for headaches — is that okay while using this gel?
It's best to avoid taking other oral NSAIDs like ibuprofen or naproxen while you're using this gel. Because diclofenac is also an NSAID, combining them raises your risk of side effects — particularly stomach bleeding and kidney strain. If you need something for a headache or pain while on this gel, talk to your pharmacist or doctor about a safe alternative for you. Acetaminophen (Tylenol) is often a reasonable option to discuss, but always check first.
I'm pregnant — is this gel safe to use?
This is a really important question to bring to your doctor right away. NSAIDs — including this gel — can cause serious harm to a developing baby, especially after about 20 weeks of pregnancy. After 30 weeks, it should be avoided entirely because it can affect the baby's kidneys and a critical blood vessel in the heart. If you are or might be pregnant, do not use this gel without first speaking with your prescriber. They'll weigh the benefits and risks and guide you to the safest option.
Is Diclofenac available over the counter?
Both — Diclofenac is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Diclofenac first available?
Diclofenac has been available in the United States since at least 1980, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Diclofenac?
Diclofenac is supplied by 225 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, Remedyrepack Inc..

💬 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

By mouth · On the skin
Brands Arthritis Pain Reliever Arthritis Pain Relieving Voltaren
Available strengths 7 strengths
Show 1 more strength Show fewer strengths
295 FDA-listed product records

Delayed-release tablet

By mouth
Available strengths 3 strengths
256 FDA-listed product records

Topical solution

On the skin
Brands Pennsaid
Available strengths 2 strengths
155 FDA-listed product records

Tablet

By mouth
Brands Cataflam Lofena
Available strengths 3 strengths
107 FDA-listed product records

Skin patch

By mouth · On the skin · Through the skin
Brands Diclofenac Epolamine Flector Licart Xiclo
Available strengths 3 strengths
44 FDA-listed product records

Extended-release tablet

By mouth
Available strengths 1 strength
35 FDA-listed product records

Capsule

By mouth
Brands Zipsor Zorvolex
Available strengths 3 strengths
32 FDA-listed product records

Oral solution

By mouth
Brands Cambia
Available strengths 1 strength
16 FDA-listed product records

Eye drops

In the eye
Available strengths 1 strength
12 FDA-listed product records

📊 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.

9
Dose forms
225
Manufacturers
40
Brand names
1,012
FDA-listed product records
1980
First marketed

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%
Remedyrepack Inc.7%
Preferred Pharmaceuticals Inc.6%
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

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 1,596 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

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 1,012 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1,012 Diclofenac NDCs →

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
  6. Dose form (SCDF) Ophthalmic Solution RxCUI 378986 In current FDA listings
    Clinical drug / strength (SCD) sodium 1 MG/ML RxCUI 854801
  7. 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
  8. Dose form (SCDF) Oral Solution RxCUI 393225 In current FDA listings
    Clinical drug / strength (SCD) sodium 0.25 MG/ML RxCUI 857689
  9. 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
  10. Dose form (SCDF) Powder for Oral Solution RxCUI 1856554 In current FDA listings
    Clinical drug / strength (SCD) potassium 50 MG RxCUI 859063
  11. 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
  12. Dose form (SCDF) Topical Cream RxCUI 438948 In current FDA listings
    Clinical drug / strength (SCD) sodium 10 MG/ML RxCUI 1043479
  13. 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.

🏷️ Sold under these brand names

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

🏭 Manufacturers & labelers

Bryant Ranch Prepack 66 A-S Medication Solutions 55 Remedyrepack Inc. 41 Preferred Pharmaceuticals Inc. 40 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 PD-Rx Pharmaceuticals, Inc. 14 Golden State Medical Supply, Inc. 14 Advanced Rx of Tennessee, LLC 13 Phoenix Rx Llc 12 Advagen Pharma Ltd 11 Direct Rx 10 AvKARE 10 St. Mary's Medical Park Pharmacy 9 RedPharm Drug, Inc. 9 Actavis Pharma, Inc. 9 RPK Pharmaceuticals, Inc. 8 American Health Packaging 8 NuCare Pharmaceuticals, Inc. 8 Amneal Pharmaceuticals LLC 8

…and 16 more on the FDA NDC directory.

RxNorm drug class

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.

🔬 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.

📄
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
1,012
Distinct labelers/manufacturers represented
225
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 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.