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Diclofenac Sodium 1 mg/mL Solution/ Drops — NDC 24208-457-05 (Billing 24208-0457-05)

by Bausch & Lomb Incorporated · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

This is a package of Diclofenac Sodium 1 mg/mL Solution/ Drops from Bausch & Lomb Incorporated, marketed since Dec 2007 and currently FDA-listed; retail pharmacies pay about $1.70 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 24208-0457-05
🏷️ FDA NDC (as labeled) 24208-457-05 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle, dropper Cost per mL$1.70 NADAC Per package$8.48 / 5 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $3.12/unit · Part D plans $2.49/unit — full pricing hub ↓
Main listing for product 24208-457 · Also comes in: 2.5 mL 24208-457-25
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 24208-457-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24208 labeler · 457 product · 05 package
Package marketed since
Dec 28, 2007
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 2420845705 4
Medicaid fills, this package
9,490 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Diclofenac Sodium (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 27, 2026 — Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0342-2026
Class III · Dec 22, 2025 — Failed PH Specifications (Cipla USA, Inc.) · FDA recall D-0291-2026
Class II · Jun 22, 2023 — Defective Delivery System (ALEMBIC PHARMACEUTICALS, INC.) · FDA recall D-0941-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24208-457-05
Product NDC 24208-457
11-digit billing NDC 24208045705
NCPDP billing unit ML — per mL (volume)
RxCUI 854801
UNII QTG126297Q
Application # ANDA078792
SPL Set ID 39dfffb0-612a-48f3-8db5-1a59899b91e9
Established class (EPC) Anti-Inflammatory Agents; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-12-28
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance DICLOFENAC SODIUM
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86805010102010
GPI class Diclofenac Sodium
GCN Seq No 016008
GCN 33831
HICL code 003733
Ingredient (HICL) Diclofenac Sodium
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6P
Therapeutic class — specific (HIC3) Eye Anti-Inflammatory Agents
AHFS code 52:08.20.00
AHFS class Eent Nonsteroidal Anti-Inflam. Agents
FDB label name DICLOFENAC 0.1% EYE DROPS
FDB brand name Diclofenac Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016008
  • GCN: 33831
  • GPI-14 (Medi-Span): 86805010102010
  • HICL (First Databank): 003733
  • AHFS class code: 52:08.20.00
  • RxCUI (RxNorm): 854801
Why two NDCs? The FDA registers this code as 24208-457-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 24208-0457-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine 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
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DICLOFENAC 0.1% EYE DROPS Ingredient Diclofenac Sodium
📗 Our plain-language guide HelloPharmacist
  • They calm inflammation after cataract surgery. They also temporarily ease pain and light sensitivity after corneal refractive surgery, such as PRK or radial keratotomy.
  • After cataract surgery, it is usually about 4 times a day, starting the day after surgery for the first 2 weeks. For refractive surgery, you use drops before and right after the pr...
  • Brief burning or stinging is the most common complaint, affecting about 15% of people. It usually passes quickly. Tell your doctor if it persists or you notice blurred vision, redn...
  • Be careful and tell your doctor first. People sensitive to aspirin or other NSAIDs may also react to diclofenac. You should not use the drops if you are allergic to any ingredient...
📖 Read our full Diclofenac Ophthalmic guide →
1
Nutrient depletion considerations

Diclofenac Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Diclofenac Sodium nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $1.695 $8.48 / 5 ml
Medicaid paysCMS SDUD · 12 mo $3.12 $15.58 / 5 ml
Medicare drug plans payPart D · Q2 2026 $2.49 $12.46 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $2.312 $1.695
▼ Down 21% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
24208-0457-05 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER $1.70 / mL $8.48 2007-12-28 — Active
24208-0457-25 24208-457-25 1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER — — 2007-12-28 — Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Diclofenac Sodium 1 mg/mL Solution/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diclofenac Sodium 1 mg/mLthis 24208-0457-05 Bausch 1 bottle $1.695 AT Availability likely —
Diclofenac Sodium 1 mg/mL 61314-0014-05 Sandoz 5 ml $1.695 AT Availability likely —
Diclofenac Sodium 1 mg/mL 72888-0150-21 Advagen 1 bottle $1.750 AT Availability likely +3%
Diclofenac Sodium 1 mg/mL 50090-2454-00 A-S 1 bottle — AT FDA listed —
Diclofenac Sodium 1 mg/mL 50090-3568-00 A-S 5 ml — AT FDA listed —
Diclofenac 1 mg/mL 59390-0149-02 Altaire 1 bottle — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2007
On the market since
Dec 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • 1 mg / 1 mL UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 6D4M1DAL6O
    Polyoxyl 35 castor oil is a synthetic compound made by chemically treating castor oil. It works as a solubilizer and emulsifier to help dissolve and evenly mix oily and water-based ingredients in medicines.
  • 2 mg / 1 mL UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB INC
FDA applicationANDA078792 (ANDA)
Labeler code24208
First marketedDec 2007
Product typeHuman Prescription Drug
Portfolio92 products on file

More NDCs from Bausch & Lomb Incorporated labeler code 24208

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

INDICATIONS AND USAGE 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.

⏱️ Dosage and Administration 92 words ▾

DOSAGE AND ADMINISTRATION 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.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS Diclofenac sodium ophthalmic solution is contraindicated in patients who are hypersensitive to any component of the medication.

⚠️ Warnings 107 words ▾

WARNINGS The refractive stability of patients undergoing corneal refractive procedures and treated with diclofenac sodium 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 nonsteroidal 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.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS 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 the 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 the 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 Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 1 words ▾

PREGNANCY

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 18 words ▾

Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

🆘 Overdosage 24 words ▾

OVERDOSAGE Overdosage will not ordinarily cause acute problems. If diclofenac sodium ophthalmic solution is accidentally ingested, fluids should be taken to dilute the medication.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamics 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. Animal Studies 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. Pharmacokinetics Results from a bioavailability study established that plasma levels of diclofenac following ocular instillation of two drops of diclofenac sodium ophthalmic solution 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.

Clinical Trials 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 and 103 patients were treated with vehicle placebo. Diclofenac sodium ophthalmic solution 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 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.

📦 How Supplied / Storage and Handling 109 words ▾

HOW SUPPLIED Diclofenac sodium ophthalmic solution, 0.1% (1 mg/mL) sterile solution is supplied in a low-density polyethylene (LDPE) white bottle with a LDPE Dropper Tip and a polypropylene gray cap. The 2.5 mL fill and the 5 mL fill are supplied in a 7.5 mL size bottle. 2.5 mL NDC 24208-457-25 5 mL NDC 24208-457-05 Store at 20°C to 25°C (68°F to 77°F).

PROTECT FROM LIGHT. Dispense in original, unopened container only. Distributed by: Bausch & Lomb Americas Inc.

Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2022 Bausch & Lomb Incorporated or its affiliates Revised: June 2022 9057308 (Folded) 9057208 (Flat)

📦 Storage and Handling 54 words ▾

Store at 20°C to 25°C (68°F to 77°F). PROTECT FROM LIGHT. Dispense in original, unopened container only. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2022 Bausch & Lomb Incorporated or its affiliates Revised: June 2022 9057308 (Folded) 9057208 (Flat)

📋 Description 163 words ▾

DESCRIPTION Diclofenac 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 C 14 H 10 Cl 2 NO 2 Na. The structural formula of diclofenac sodium is: Diclofenac sodium ophthalmic solution is available as a sterile solution, which contains diclofenac sodium 0.1% (1 mg/mL).

Inactive Ingredients: boric acid, edetate disodium (1 mg/mL), polyoxyl 35 castor oil, purified water, sorbic acid (2 mg/mL), and tromethamine. Diclofenac sodium is a white to off-white, 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 has a faint characteristic odor of castor oil.

Diclofenac Sodium (structural formula)

💬 Information for Patients 47 words ▾

Information for Patients 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.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General 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.

Information for Patients 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. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in rats given diclofenac sodium 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 up to 2 mg/kg/day did not reveal any oncogenic potential. Diclofenac sodium did not show mutagenic potential in various mutagenicity studies including the Ames test. Diclofenac sodium administered to male and female rats at 4 mg/kg/day (approximately 1000 times the human topical ophthalmic dose) did not affect fertility.

Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients. PREGNANCY Teratogenic Effects 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 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 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. Non-teratogenic Effects Because of the known effects of prostaglandin biosynthesis inhibiting drugs on the fetal cardiovascular… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 61 words ▾

Nursing Women It is not known whether topical ophthalmic administration of diclofenac sodium ophthalmic solution 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.

🧬 Pharmacokinetics 53 words ▾

Pharmacokinetics Results from a bioavailability study established that plasma levels of diclofenac following ocular instillation of two drops of diclofenac sodium ophthalmic solution 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.

🧬 Pharmacodynamics 37 words ▾

Pharmacodynamics 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.

🔬 Clinical Studies 143 words ▾

Clinical Trials 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 and 103 patients were treated with vehicle placebo. Diclofenac sodium ophthalmic solution 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 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 94 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in rats given diclofenac sodium 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 up to 2 mg/kg/day did not reveal any oncogenic potential. Diclofenac sodium did not show mutagenic potential in various mutagenicity studies including the Ames test.

Diclofenac sodium administered to male and female rats at 4 mg/kg/day (approximately 1000 times the human topical ophthalmic dose) did not affect fertility.

📄 Package Label / Principal Display Panel 33 words ▾

Package/Label Display Panel – 5 mL carton NDC 24208-457-05 Diclofenac Sodium Ophthalmic Solution 0.1% (Sterile) FOR TOPICAL APPLICATION IN THE EYE [Eye Image] Rx only 5 mL BAUSCH + LOMB 9542403 AB45707 CARTON

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
9.5K
Units reimbursed last 4 qtrs
51K
Gross reimbursed last 4 qtrs
$158.9K
Avg / prescription
$16.74
Avg / unit
$3.1155
Latest quarter Q1 2026
1.5KRx
Medicaid pays / mL
$3.1155
gross reimbursed
vs
NADAC / mL
$1.6954
acquisition cost
=
Spread
+$1.4201
+84% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
52% FFS 48% MCO
Fee-for-service · 4,982 Rx Managed care · 4,508 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,120 units · 14.3 per 100k residents WA Idaho: 200 units · 10.2 per 100k residents ID Montana: 573 units · 50.6 per 100k residents MT North Dakota: no data reported ND Minnesota: 215 units · 3.7 per 100k residents MN Wisconsin: 733 units · 12.4 per 100k residents WI Michigan: 1,585 units · 15.8 per 100k residents MI New York: 4,830 units · 24.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,310 units · 30.9 per 100k residents OR Nevada: 385 units · 12.1 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 55 units · 1.7 per 100k residents IA Illinois: 648 units · 5.2 per 100k residents IL Indiana: 1,565 units · 22.8 per 100k residents IN Ohio: 2,065 units · 17.5 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 2,708 units · 29.1 per 100k residents NJ Massachusetts: 1,230 units · 17.6 per 100k residents MA California: 16,475 units · 42.3 per 100k residents CA Utah: no data reported UT Colorado: 930 units · 15.8 per 100k residents CO Nebraska: no data reported NE Missouri: 145 units · 2.3 per 100k residents MO Kentucky: 1,452 units · 32.1 per 100k residents KY West Virginia: 220 units · 12.4 per 100k residents WV Virginia: 695 units · 8.0 per 100k residents VA Maryland: 995 units · 16.1 per 100k residents MD Connecticut: 475 units · 13.1 per 100k residents CT Rhode Island: 60 units · 5.5 per 100k residents RI Arizona: 2,087 units · 28.1 per 100k residents AZ New Mexico: 355 units · 16.8 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 500 units · 7.0 per 100k residents TN North Carolina: 1,523 units · 14.1 per 100k residents NC South Carolina: 360 units · 6.7 per 100k residents SC Delaware: 380 units · 36.9 per 100k residents DE Oklahoma: 55 units · 1.4 per 100k residents OK Louisiana: 360 units · 7.9 per 100k residents LA Mississippi: no data reported MS Alabama: 270 units · 5.3 per 100k residents AL Georgia: 753 units · 6.8 per 100k residents GA D.C.: 55 units · 8.1 per 100k residents DC Hawaii: 1,165 units · 81.2 per 100k residents HI Texas: no data reported TX Florida: 2,470 units · 10.9 per 100k residents FL
Units reimbursed · per 100k residents
1.481.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Hawaii 81.2 /100k
2 Montana 50.6 /100k
3 California 42.3 /100k
4 Delaware 36.9 /100k
5 Kentucky 32.1 /100k
6 Oregon 30.9 /100k
7 New Jersey 29.1 /100k
8 Arizona 28.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page24208-0457-05 9,490 Rx · $158,893
1 bottle24208-0457-25 No Medicaid data
Drug total (last 4 qtrs): 9,490 Rx · 51,001 units · $158,893 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Diclofenac Sodium — the program that covers self-administered drugs. 19 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Diclofenac Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$30M
Claims incl. refills
804.1K
Beneficiaries
539.2K
Spend / beneficiary
$55.63
Spend / claim
$37.30
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 24208-0454-30 · Bausch 24208-0463-25 · Bausch →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.