Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1)] . D iclofenac sodium topical solution is contraindicated in the setting of coronary artery ...
Diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis.
Diclofenac sodium topical solution 1.5% w/w is supplied as a clear, colorless to faintly pink-orange solution containing 16.05 mg of diclofenac sodium per 1 mL of solution, in a white high density polyethylene bottle with a white low-density dropper cap. It is available as follows: 150 mL bottle NDC 65162-911-74 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see...
www.fda.gov/medwatch
www.amneal.comCardiovascular Thrombotic Events
Gastrointestinal Bleeding, Ulceration, and Perforation
Diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis.
Diclofenac sodium topical solution: 1.5% w/w
Diclofenac sodium topical solution is contraindicated in the following patients:
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to diclofenac sodium topical solution of 911 patients treated between 4 and 12 weeks (mean duration of 49 days) in seven Phase 3 controlled trials, as well as exposure of 793 patients treated in an open-label study, including 463 patients treated for at least 6 months, and 144 patients treated for at least 12 months. The population mean age was approximately 60 years, 89% of patients were Caucasians, 64% were females, and all patients had primary osteoarthritis. The most common adverse events with diclofenac sodium topical solution were application site skin reactions. These events were the most common reason for withdrawing from the studies.
Application Site Reactions
In controlled trials, the most common treatment-related adverse events in patients receiving diclofenac sodium topical solution were application site skin reactions. Application site reactions were characterized by one or more of the following: dryness, erythema, induration, vesicles, paresthesia, pruritus, vasodilation, acne, and urticaria. The most frequent of these reactions were dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%) and pruritus (4%). In one controlled trial, a higher rate of contact dermatitis with vesicles (4%) was observed after treatment of 152 subjects with the combination of diclofenac sodium topical solution and oral diclofenac. In the open label uncontrolled long-term safety study, contact dermatitis occurred in 13% and contact dermatitis with vesicles in 10% of patients, generally within the first 6 months of exposure, leading to a withdrawal rate for an application site event of 14%.
Adverse Events Common to the NSAID Class
In controlled trials, subjects treated with diclofenac sodium topical solution experienced some adverse events associated with the NSAID class more frequently than subjects using placebo (constipation, diarrhea, dyspepsia, nausea, flatulence, abdominal pain, edema; see Table 1). The combination of diclofenac sodium topical solution and oral diclofenac, compared to oral diclofenac alone, resulted in a higher rate of rectal hemorrhage (3% vs. less than 1%), and more frequent abnormal creatinine (12% vs. 7%), urea (20% vs. 12%), and hemoglobin (13% vs. 9%), but no difference in elevation of liver transaminases.
Table 1 lists all adverse reactions occurring in ≥ 1% of patients receiving diclofenac sodium topical solution, where the rate in the diclofenac sodium topical solution group exceeded placebo, from seven controlled studies conducted in patients with osteoarthritis. Since these trials were of different durations, these percentages do not capture cumulative rates of occurrence.
Table 1: Adverse Reactions occurring in ≥ 1% of patients treated with diclofenac sodium topical solution in placebo and oral diclofenac-controlled trials.
Treatment Group: | Diclofenac sodium topical solution N=911 | Topical Placebo N=332 |
Adverse Reaction† | N (%) | N (%) |
Dry Skin (Application Site) | 292 (32) | 17 (5) |
Contact Dermatitis (Application Site) | 83 (9) | 6 (2) |
Dyspepsia | 72 (8) | 13 (4) |
Abdominal Pain | 54 (6) | 10 (3) |
Flatulence | 35 (4) | 1 (<1) |
Pruritus (Application Site) | 34 (4) | 7 (2) |
Diarrhea | 33 (4) | 7 (2) |
Nausea | 33 (4) | 3 (1) |
Pharyngitis | 40 (4) | 13 (4) |
Constipation | 29 (3) | 1 (<1) |
Edema | 26 (3) | 0 |
Rash (Non-Application Site) | 25 (3) | 5 (2) |
Infection | 25 (3) | 8 (2) |
Ecchymosis | 19 (2) | 1 (<1) |
Dry Skin (Non-Application Site) | 19 (2) | 1 (<1) |
Contact Dermatitis, vesicles (Application Site) | 18 (2) | 0 |
Paresthesia (Non-Application Site) | 14 (2) | 3 (<1) |
Accidental Injury | 22 (2) | 7 (2) |
Pruritus (Non-Application Site) | 15 (2) | 2 (<1) |
Sinusitis | 10 (1) | 2 (<1) |
Halitosis | 11 (1) | 1 (<1) |
Application Site Reaction (not otherwise specified) | 11 (1) | 3 (<1) |
†Preferred Term according to COSTART | ||
In non-U.S. postmarketing surveillance, the following adverse reactions have been reported during post-approval use of diclofenac sodium topical solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole: abdominal pain, accidental injury, allergic reaction, asthenia, back pain, body odor, chest pain, edema, face edema, halitosis, headache, lack of drug effect, neck rigidity, pain
Cardiovascular: palpitation, cardiovascular disorder
Digestive: diarrhea, dry mouth, dyspepsia, gastroenteritis, decreased appetite, mouth ulceration, nausea, rectal hemorrhage, ulcerative stomatitis
Metabolic and Nutritional: creatinine increased
Musculoskeletal: leg cramps, myalgia
Nervous: depression, dizziness, drowsiness, lethargy, paresthesia, paresthesia at application site
Respiratory: asthma, dyspnea, laryngismus, laryngitis, pharyngitis
Skin and Appendages: At the Application Site: Adverse Reactions: contact dermatitis, contact dermatitis with vesicles, dry skin, pruritus, rash; Other Skin and Appendages: eczema, rash, pruritus, skin discoloration, urticaria
Special Senses: abnormal vision, blurred vision, cataract, ear pain, eye disorder, eye pain, taste perversion
See Table 2 for clinically significant drug interactions with diclofenac.
Table 2: Clinically Significant Drug Interactions with Diclofenac
Drugs That Interfere with Hemostasis | |
Clinical Impact: |
|
Intervention: | Monitor patients with concomitant use of diclofenac sodium topical solution with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions (5.12)] |
Aspirin | |
Clinical Impact: | Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of NSAID alone [see Warnings and Precautions (5.2)] |
Intervention: | Concomitant use of diclofenac sodium topical solution and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions (5.12)]. Diclofenac sodium topical solution is not a substitute for low dose aspirin for cardiovascular protection. |
ACE inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers | |
Clinical Impact: |
|
Intervention: |
|
Diuretics | |
Clinical Impact: | Clinical studies, as well as post-marketing observations, showed that NSAIDS reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. |
Intervention: | During concomitant use of diclofenac sodium topical solution with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see Warnings and Precautions (5.6)]. |
Digoxin | |
Clinical Impact: | The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life digoxin. |
Intervention: | During concomitant use of diclofenac sodium topical solution and digoxin, monitor serum digoxin levels. |
Lithium | |
Clinical Impact: | NSAIDS have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. |
Intervention: | During concomitant use of diclofenac sodium topical solution and lithium, monitor patients for signs of lithium toxicity. |
Methotrexate | |
Clinical Impact: | Concomitant use of NSAIDs and methotrexate may increase the risk of methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). |
Intervention: | During concomitant use of diclofenac sodium topical solution and methotrexate, monitor patients for methotrexate toxicity. |
Cyclosporine | |
Clinical Impact: | Concomitant use of diclofenac sodium topical solution and cyclosporine may increase cyclosporine’s nephrotoxicity. |
Intervention: | During concomitant use of diclofenac sodium topical solution and cyclosporine, monitor patients for signs or worsening renal function. |
NSAIDs and Salicylates | |
Clinical Impact: | Concomitant use of diclofenac with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see Warnings and Precautions (5.2)]. Concomitant use of oral NSAIDs with diclofenac sodium topical solution has been evaluated in one Phase 3 controlled trial and in combination with oral diclofenac, compared to oral diclofenac alone, resulted in a higher rate of rectal hemorrhage (3% vs. less than 1%), and more frequent abnormal creatinine (12% vs. 7%), urea (20% vs. 12%) and hemoglobin (13% vs. 9%). |
Intervention: | The concomitant use of diclofenac with other NSAIDs or salicyclates is not recommended. Do not use combination therapy with diclofenac sodium topical solution and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations |
Pemetrexed | |
Clinical Impact: | Concomitant use of diclofenac sodium topical solution and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). |
Intervention: | During concomitant use of diclofenac sodium topical solution and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. |
Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see Warnings and Precautions (5.1,5.2,5.4,5.6)].
Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Emesis is not recommended due to a possibility of aspiration and subsequent respiratory irritation by DMSO contained in diclofenac sodium topical solution. Consider activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdose treatment, contact a poison control center (1-800-222-1222).
Diclofenac sodium topical solution 1.5% is a nonsteroidal anti-inflammatory drug, available as a clear, colorless to faintly pink-orange solution for topical application.
Diclofenac sodium topical solution contains 1.5% w/w diclofenac sodium, USP, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid, monosodium salt. It is a white to off-white crystalline powder, hygroscopic, and odorless that is freely soluble in methanol, soluble in alcohol, and sparingly soluble in water. The molecular weight is 318.13. Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula.
Each 1 mL of solution contains 16.05 mg of diclofenac sodium, USP. The inactive ingredients in diclofenac sodium topical solution include: alcohol, dimethyl sulfoxide USP (DMSO, 45.5% w/w), glycerin, propylene glycol, and purified water.
Diclofenac sodium topical solution 1.5% w/w is supplied as a clear, colorless to faintly pink-orange solution containing 16.05 mg of diclofenac sodium per 1 mL of solution, in a white high density polyethylene bottle with a white low-density dropper cap. It is available as follows:
150 mL bottle NDC 65162-911-74
Storage
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Advise the patient to read the FDA-approved patient labeling (Medication Guide) and Instructions for Use that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with diclofenac sodium topical solution and periodically during the course of ongoing therapy.
Cardiovascular Thrombotic Events
Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [see Warnings and Precautions (5.1)].
Gastrointestinal Bleeding, Ulceration, and Perforation
Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions (5.2)].
Hepatotoxicity
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop diclofenac sodium topical solution and seek immediate medical therapy [see Warnings and Precautions (5.3)].
Heart Failure and Edema
Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see Warnings and Precautions (5.5)].
Anaphylactic Reactions
Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see Contraindications (4) and Warnings and Precautions (5.7)].
Serious Skin Reactions, including DRESS
Advise patients to stop taking diclofenac sodium topical solution immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [see Warnings and Precautions (5.9, 5.10)].
Female Fertility
Advise females of reproductive potential who desire pregnancy that NSAIDs, including diclofenac sodium topical solution, may be associated with a reversible delay in ovulation [see Use in Specific Populations (8.3)]
Fetal Toxicity
Inform pregnant women to avoid use of diclofenac sodium topical solution and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with diclofenac sodium topical solution is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [see Warnings and Precautions (5.11) and Use in Specific Populations (8.1)].
Avoid Concomitant Use of NSAIDs
Inform patients that the concomitant use of diclofenac sodium topical solution with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see Warnings and Precautions (5.2)and Drug Interactions (7)]. Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia.
Use of NSAIDS and Low-Dose Aspirin
Inform patients not to use low-dose aspirin concomitantly with diclofenac sodium topical solution until they talk to their healthcare provider [see Drug Interactions (7)].
Eye Exposure
Instruct patients to avoid contact of diclofenac sodium topical solution with the eyes and mucosa. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour.
Prevention of Secondary Exposure
Instruct patients to avoid skin-to-skin contact between other people and the knee(s) to which diclofenac sodium topical solution was applied until the knee(s) is completely dry.
Application Site Reactions
Diclofenac sodium topical solution can cause a localized skin reaction at the application site. Advise patients to contact their physicians as soon as possible if they develop any type of localized application site rash.
Special Application Instructions
Distributed by:
Amneal Pharmaceuticals
Bridgewater, NJ 08807
Rev. 05-2021-03
What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including:
| |
The risk of getting an ulcer or bleeding increases with:
| |
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NSAIDs should only be used:
| |
What are NSAIDs? NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. | |
Who should not take NSAIDs? Do not take NSAIDs:
| |
Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first. | |
What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)?
Get emergency help right away if you get any of the following symptoms: | |
|
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Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: | |
|
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If you take too much of your NSAID, call your healthcare provider or get medical help right away. These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |
Other information about NSAIDs
| |
General information about the safe and effective use of NSAIDs Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals. | |
Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 For more information, go to | |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised 11-2020-02
Diclofenac (dye-KLOE-fen-ak) Sodium Topical Solution 1.5%
Read the Medication Guide that comes with diclofenac sodium topical solution first. Be sure that you read, understand and follow these Instructions for Use before you use diclofenac sodium topical solution for the first time.
Important: For use on the skin only (topical). Do not get diclofenac sodium topical solution in your eyes, nose or mouth.
Before you use diclofenac sodium topical solution:
Steps for using diclofenac sodium topical solution:
Step 1. Wash your hands with soap and water before applying diclofenac sodium topical solution.
Step 2. Put 10 drops of diclofenac sodium topical solution either on your hand or directly on your knee (see Figure A).
Step 3. Spread diclofenac sodium topical solution evenly on the front, back and sides of your knee (see Figures B and C). Repeat steps 2 and 3, three times so that your knee is completely covered with a total of 40 drops of diclofenac sodium topical solution.
Step 4. If your healthcare provider has prescribed diclofenac sodium topical solution for both knees, repeat steps 2 and 3 for the other knee.
After you use diclofenac sodium topical solution:
Do not:
How should I store diclofenac sodium topical solution?
Keep diclofenac sodium topical solution and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
*Trademarks are the property of their respective owners.
Distributed by:
Amneal PharmaceuticalsBridgewater, NJ 08807
Rev. 11-2016-01
Menthol
Methyl Salicylate
Topical analgesic
Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center Immediately.
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
For external use only
Do not use:
On wounds or damaged skin
With a heating pad
On a child under 12 years of age with arthritis-like conditions
Ask a doctor before use if
you haveredness over the affected area
When using this product
Avoid contact with eyes
Do not bandage tightly
Stop use and ask a doctor if
Condition worsens or symptoms persist for more than 7 days
Symptoms clear up and occur again within a few days
Excessive skin irritation occurs
Adults and children 12 years of age and older:
apply to affected area not more than 3 to 4 times daily
wash hands with soap and water after apply
Children under 12 years of age: ask a doctor
Citric Acid monohydrate, Glyceryl Monostearate, Lanolin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Polysorbate 80, Stearic Acid, Trolamine
The packaging for Torvexa is shown below:
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| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65162-911-74 | ML - Milliliter | 65162-911 | 30077597-76c0-4ba1-aae4-2a735eff933d | 1 | 2016-10-06 |
| 51824-105-03 | GM - Gram | 51824-105 | 992b78a7-1bbe-4acb-af5c-88ec94b81048 | 1 | 2024-11-05 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 84460-805 | 84460-805-01 |
| 65162-911 | 65162-911-74 |
| 51824-105 | 51824-105-03 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Diclofenac Sodium | QTG126297Q | ACTIB |
| Dimethyl Sulfoxide | YOW8V9698H | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Alcohol | 3K9958V90M | IACT |
| Water | 059QF0KO0R | IACT |
| LEVOMENTHOL | BZ1R15MTK7 | ACTIB |
| METHYL SALICYLATE | LAV5U5022Y | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| LANOLIN | 7EV65EAW6H | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-08-06 | daily-update | 2026-08-11 01:06:01 |
| 1 | 2026-03-24 | full-release | 2026-05-31 22:11:13 |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206116-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 |
| Application-product | TE code |
|---|---|
| A206116-001 | AT |
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| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206116-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2016-09-02 | 3a93d1ddd44b… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A206116-001 | AT | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A206116-001 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A206116-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206116-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206116-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206116-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206116-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206116-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206116-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206116-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206116-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206116-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206116-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206116-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206116-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206116-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A206116-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206116-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A206116-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A206116-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A206116-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A206116-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A206116-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206116-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206116-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A206116-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A206116-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A206116-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A206116-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A206116-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206116-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A206116-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A206116-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206116-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206116-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206116-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206116-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A206116-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A206116-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206116-001 | AT | 1 | 3a93d1ddd44b… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| bdd091c3-6a57-431a-bb8d-aa30d68c8d04 | 55a35d04-d75b-4e76-972f-4710035763c9 | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | 55a35d04-d75b-4e76-972f-4710035763c9 | ||
| Orthrexo | DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE | V2 Pharma, LLC | eb070904-4f6f-42c0-981d-8dc850040185 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 65162-911-74 51824-105-03 65162091174 51824010503 |
| CAREALL Muscle Rub Ultra Strength | MENTHOL, METHYL SALICYLATE | New World Imports, Inc | d066002d-8ceb-4d16-9744-d5ca25d2ad5a | 2025-12-01 | Warnings | 51824-105-03 51824-105 51824010503 |
| Orthaphen | DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE | V2 Pharma, LLC | 1583e691-5823-4a68-aafc-bf80b8854233 | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | 65162-911-74 51824-105-03 65162091174 51824010503 |
| Fenovar | DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE | V2 Pharma, LLC | cca25bd7-2afd-4ff1-adb3-0a77dfcd4342 | 2024-11-01 | Boxed warning, Warnings, Adverse reactions | 65162-911-74 51824-105-03 65162091174 51824010503 |
| Diclofenac Sodium | DICLOFENAC | Amneal Pharmaceuticals LLC | 78873f83-cea9-44d4-8ad4-8cb9257e5c7f | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | 65162-911-74 65162-911 65162091174 |
Adverse event summaries are temporarily unavailable. Other product information remains available.