Diclofenac sodium ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.
Cataract Surgery One drop of diclofenac sodium ophthalmic solution should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the postoperative period. Corneal Refractive Surgery One or two drops of diclofenac sodium ophthalmic solution should be applied to the operative eye within the hour prior to corneal refractive surgery. Withi...
www.fda.gov/medwatchDiclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt, with an empirical formula of C14H10Cl2NO2Na. The structural formula of diclofenac sodium is:
Diclofenac sodium ophthalmic solution, 0.1% is available as a sterile solution which contains diclofenac sodium 0.1% (1 mg/mL).
Inactive Ingredients: polyoxyl 35 castor oil, boric acid, tromethamine, sorbic acid (2 mg/mL), edetate disodium (1 mg/mL), and purified water.
Diclofenac sodium is a faintly yellow-white to light-beige, slightly hygroscopic crystalline powder. It is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular weight is 318.14. Diclofenac sodium ophthalmic solution, 0.1% is an iso-osmotic solution with an osmolality of about 300 mOsmol/1000 g, buffered at approximately pH 7.2. Diclofenac sodium ophthalmic solution, 0.1% has a faint characteristic odor of castor oil.
Diclofenac sodium is one of a series of phenylacetic acids that has demonstrated anti-inflammatory and analgesic properties in pharmacological studies. It is thought to inhibit the enzyme cyclooxygenase, which is essential in the biosynthesis of prostaglandins.
Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
Results from a bioavailability study established that plasma levels of diclofenac following ocular instillation of two drops of diclofenac sodium ophthalmic solution, 0.1% to each eye were below the limit of quantification (10 ng/mL) over a 4-hour period. This study suggests that limited, if any, systemic absorption occurs with diclofenac sodium ophthalmic solution, 0.1%.
Postoperative Anti-Inflammatory Effects
In two double-masked, controlled, efficacy studies of postoperative inflammation, a total of 206 cataract patients were treated with diclofenac sodium ophthalmic solution, 0.1% and 103 patients were treated with vehicle placebo. Diclofenac sodium ophthalmic solution, 0.1% was favored over vehicle placebo over a 2-week period for the clinical assessments of inflammation as measured by anterior chamber cells and flare.
In double-masked, controlled studies of corneal refractive surgery (radial keratotomy (RK) and laser photorefractive keratectomy (PRK)) patients were treated with diclofenac sodium ophthalmic solution, 0.1% and/or vehicle placebo. The efficacy of diclofenac sodium ophthalmic solution given before and shortly after surgery was favored over vehicle placebo during the 6-hour period following surgery for the clinical assessments of pain and photophobia. Patients were permitted to use a hydrogel soft contact lens with diclofenac sodium ophthalmic solution for up to three days after PRK.
Ocular
Transient burning and stinging were reported in approximately 15% of patients across studies with the use of diclofenac sodium ophthalmic solution. In cataract surgery studies, keratitis was reported in up to 28% of patients receiving diclofenac sodium ophthalmic solution, although in many of these cases keratitis was initially noted prior to the initiation of treatment. Elevated intraocular pressure following cataract surgery was reported in approximately 15% of patients undergoing cataract surgery.
Lacrimation complaints were reported in approximately 30% of case studies undergoing incisional refractive surgery. The following adverse reactions were reported in approximately 10% or less of patients: abnormal vision, acute elevated IOP, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, eye pain, injection (redness), iritis, irritation, itching, lacrimation disorder, and ocular allergy.
Systemic
The following adverse reactions were reported in 3% or less of patients: abdominal pain, asthenia, chills, dizziness, facial edema, fever, headache, insomnia, nausea, pain, rhinitis, viral infection, and vomiting.
Clinical Practice
The following reactions have been identified during postmarketing use of topical diclofenac sodium ophthalmic solution, 0.1% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical diclofenac sodium ophthalmic solution, 0.1%, or a combination of these factors, include corneal erosion, corneal infiltrates, corneal perforation, corneal thinning, corneal ulceration, and epithelial breakdown [see PRECAUTIONS, General].
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Diclofenac sodium ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.
Diclofenac sodium ophthalmic solution is contraindicated in patients who are hypersensitive to any component of the medication.
The refractive stability of patients undergoing corneal refractive procedures and treated with diclofenac sodium ophthalmic solution has not been established. Patients should be monitored for a year following use in this setting. With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied non-steroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
Use of topical NSAIDs may result in keratitis. In some susceptible patients continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal infiltrates, corneal erosion, corneal ulceration, and corneal perforation. These events may be sight-threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.
Postmarketing experience with topical NSAIDs suggests that patients experiencing complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events, which may become sight-threatening. Topical NSAIDs should be used with caution in these patients.
Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for occurrence and severity of corneal adverse events.
It is recommended that diclofenac sodium ophthalmic solution, like other NSAIDs, be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.
Results from clinical studies indicate that diclofenac sodium ophthalmic solution has no significant effect upon ocular pressure. However, elevations in intraocular pressure may occur following cataract surgery.
Except for the use of a bandage hydrogel soft contact lens during the first 3 days following refractive surgery, diclofenac sodium ophthalmic solution should not be used by patients currently wearing soft contact lenses due to adverse events that have occurred in other circumstances.
Long-term carcinogenicity studies in rats given diclofenac sodium ophthalmic solution in oral doses up to 2 mg/kg/day (approximately 500 times the human topical ophthalmic dose) revealed no significant increases in tumor incidence. A 2-year carcinogenicity study conducted in mice employing oral diclofenac sodium ophthalmic solution up to 2 mg/kg/day did not reveal any oncogenic potential. Diclofenac sodium ophthalmic solution did not show mutagenic potential in various mutagenicity studies including the Ames test. Diclofenac sodium ophthalmic solution administered to male and female rats at 4 mg/kg/day (approximately 1000 times the human topical ophthalmic dose) did not affect fertility.
No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
Pregnancy Category C.Reproduction studies performed in mice at oral doses up to 5,000 times (20 mg/kg/day) and in rats and rabbits at oral doses up to 2,500 times (10 mg/kg/day) the human topical dose have revealed no evidence of teratogenicity due to diclofenac sodium ophthalmic solution despite the induction of maternal toxicity and fetal toxicity. In rats, maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival. Diclofenac sodium ophthalmic solution has been shown to cross the placental barrier in mice and rats.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of diclofenac sodium ophthalmic solution during late pregnancy should be avoided.
Nursing Women
It is not known whether topical ophthalmic administration of diclofenac sodium ophthalmic solution, 0.1% could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
Ocular
Transient burning and stinging were reported in approximately 15% of patients across studies with the use of diclofenac sodium ophthalmic solution. In cataract surgery studies, keratitis was reported in up to 28% of patients receiving diclofenac sodium ophthalmic solution, although in many of these cases keratitis was initially noted prior to the initiation of treatment. Elevated intraocular pressure following cataract surgery was reported in approximately 15% of patients undergoing cataract surgery.
Lacrimation complaints were reported in approximately 30% of case studies undergoing incisional refractive surgery. The following adverse reactions were reported in approximately 10% or less of patients: abnormal vision, acute elevated IOP, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, eye pain, injection (redness), iritis, irritation, itching, lacrimation disorder, and ocular allergy.
Systemic
The following adverse reactions were reported in 3% or less of patients: abdominal pain, asthenia, chills, dizziness, facial edema, fever, headache, insomnia, nausea, pain, rhinitis, viral infection, and vomiting.
Clinical Practice
The following reactions have been identified during postmarketing use of topical diclofenac sodium ophthalmic solution, 0.1% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical diclofenac sodium ophthalmic solution, 0.1%, or a combination of these factors, include corneal erosion, corneal infiltrates, corneal perforation, corneal thinning, corneal ulceration, and epithelial breakdown [see PRECAUTIONS, General].
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Overdosage will not ordinarily cause acute problems. If diclofenac sodium ophthalmic solution is accidentally ingested, fluids should be taken to dilute the medication.
Cataract Surgery
One drop of diclofenac sodium ophthalmic solution should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the postoperative period.
Corneal Refractive Surgery
One or two drops of diclofenac sodium ophthalmic solution should be applied to the operative eye within the hour prior to corneal refractive surgery. Within 15 minutes after surgery, one or two drops should be applied to the operative eye and continued 4 times daily for up to 3 days.
Product: 50090-3568
NDC: 50090-3568-0 5 mL in a BOTTLE
Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc.
Princeton, NJ 08540
Rev. September 2021
300051855-0921
| Class | Version | Type | Effective |
|---|---|---|---|
| DICLOFENAC Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20190118 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 77dc03a4-fbfc-e6a3-fe95-285bbae40d75 | Product name | 2 | 20250814 |
| 111d457e-3138-4512-b0ba-d0cd760c4055 | Product name | 3 | 20250225 |
| 0426261e-1bb9-b78b-abd2-80da765a7e3e | Product name | 2 | 20240513 |
| 7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7 | Product name | 5 | 20240320 |
| 0ac2f11f-f58d-baf2-71a0-680993b48a61 | Product name | 2 | 20231211 |
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| c4e1eedc-aca2-4551-8382-89144ed9d049 | Product name | 3 | 20220126 |
| 8d368a34-1453-43ea-828d-0dbcd72b8794 | Product name | 8 | 20210622 |
| d6bab9d2-edce-a213-4796-226ab15472c3 | Product name | 6 | 20200616 |
| 2487e6ef-d419-42fc-aaf8-7acc805d2370 | Product name | 2 | 20170718 |
| e071c814-e5e7-e7ed-ec76-428765d9c66b | Product name | 2 | 20151120 |
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| dbb00be6-fb1c-4b0a-a770-31f7e05e247e | Product name | 1 | 20150316 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-3568-0 | Diclofenac Sodium | 5 mL in 1 BOTTLE | SOLUTION | 5 | 6 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-3568 | DICLOFENAC SODIUM SOLUTION [A-S MEDICATION SOLUTIONS] | 6 | Current NDC, 1 package rows | 20230317_3a520306-fe3e-4830-963f-04b080db3abc.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-3568-0 | ML - Milliliter | 50090-3568 | 81bcca2d-af4f-4bc4-9a6b-712c3b767241 | 1 | 2023-04-07 |
| 61314-014-05 | ML - Milliliter | 61314-014 | a52f7e4c-3267-4c4c-8e38-2cb6d9442573 | 1 | 2012-07-24 |
| 61314-014-25 | ML - Milliliter | 61314-014 | ab7d2340-c8c7-4e03-baa1-a023f9f720a1 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50090-3568 | 50090-3568-0 |
| 61314-014 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DICLOFENAC SODIUM | QTG126297Q | ACTIB |
| POLYOXYL 35 CASTOR OIL | 6D4M1DAL6O | IACT |
| BORIC ACID | R57ZHV85D4 | IACT |
| TROMETHAMINE | 023C2WHX2V | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A078031-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 |
| Application-product | TE code |
|---|---|
| A078031-001 | AT |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
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| 2026-02-19 14:30 UTC | 2026-02 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A078031-001 | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS / OPHTHALMIC | AT | 2008-02-06 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078031-001 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078031-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078031-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078031-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078031-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078031-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078031-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078031-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078031-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078031-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078031-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078031-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078031-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078031-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078031-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078031-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078031-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078031-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078031-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078031-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078031-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078031-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078031-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A078031-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A078031-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A078031-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A078031-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A078031-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A078031-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078031-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A078031-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A078031-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078031-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078031-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078031-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078031-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A078031-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A078031-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078031-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A078031-001 | AT | 1 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Diclofenac Sodium | DICLOFENAC SODIUM | A-S Medication Solutions | 3a520306-fe3e-4830-963f-04b080db3abc | 2022-06-01 | Warnings, Adverse reactions | 50090-3568-0 50090-3568 50090356800 3f758075-7120-495a-9e3b-6370828dc758 3a520306-fe3e-4830-963f-04b080db3abc |
| Diclofenac Sodium | DICLOFENAC SODIUM | Sandoz Inc | 52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b | 2021-09-29 | Warnings, Adverse reactions | 61314-014 |
Adverse event summaries are temporarily unavailable. Other product information remains available.