FDA-filed SPL labeling · retrieved through openFDA

Loteprednol Etabonate

Loteprednol etabonate is a corticosteroid eye medication used to treat eye inflammation from various causes, relieve dry eye disease symptoms, and manage pain and inflammation after eye surgery.

Brand names LotemaxInveltysAlrexEysuvisLotemax SM
Drug class ⓘ Corticosteroid
Rx Forms 3 Routes Ophthalmic · Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 26 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMar 11, 2025
Clinical labels in scope ⓘ26
AvailabilityRx
Earliest approval/marketing year ⓘ1998
FDA-listed product records ⓘ62
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Loteprednol Etabonate at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Loteprednol etabonate is a targeted corticosteroid eye medication that effectively reduces inflammation and pain in the eye, with a relatively low risk of raising eye pressure compared to some other steroid eye drops. Different brand products are approved for different uses — from seasonal eye allergies and dry eye disease to post-surgical recovery — so always use the specific product your doctor prescribed. Regular follow-up with your eye doctor during treatment is important, especially if you use it for more than 10 days.
How we write & review this content — our editorial policy →

📖 Loteprednol Etabonate: Patient Information Guide

A plain-language walkthrough of Loteprednol Etabonate — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Loteprednol etabonate is a corticosteroid eye medication available in several branded products, each approved for specific uses:

  • Alrex (eye drops): temporary relief of the signs and symptoms of seasonal allergic conjunctivitis (eye allergies)
  • Eysuvis (eye drops): short-term treatment (up to two weeks) of the signs and symptoms of dry eye disease
  • Inveltys (eye drops/topical suspension): treatment of post-operative inflammation and pain following eye surgery
  • Lotemax (eye drops/suspension): treatment of steroid-responsive inflammatory eye conditions — including allergic conjunctivitis, iritis (iris inflammation), cyclitis, herpes zoster keratitis, superficial punctate keratitis, acne rosacea affecting the eye, and selected eye infections — as well as post-operative inflammation after eye surgery
  • Lotemax (ointment): post-operative inflammation and pain following eye surgery
  • Lotemax (gel): post-operative inflammation and pain following eye surgery
  • Lotemax SM (gel): post-operative inflammation and pain following eye surgery
  • Loteprednol etabonate ophthalmic suspension: steroid-responsive inflammatory eye conditions and post-operative inflammation after eye surgery
⚙️How it works▾

Loteprednol etabonate is a corticosteroid that binds to glucocorticoid receptors in eye tissue. Once activated, it dials down multiple parts of the inflammatory process — reducing swelling, blocking immune cells from flooding the area, inhibiting the formation of new blood vessels in inflamed tissue, and suppressing the production of prostaglandins (chemicals that drive pain and swelling). The result is less redness, pain, and irritation in the eye.

💊How it's taken▾

Loteprednol etabonate is applied directly to the eye and is never taken by mouth. Always wash your hands before use and shake the bottle as directed for your specific product. Frequency depends on the product and condition being treated:

  • Alrex eye drops: one drop in the affected eye(s) four times daily
  • Eysuvis eye drops: one to two drops in each eye four times daily, for up to two weeks
  • Inveltys: one to two drops in the affected eye twice daily, starting the day after surgery and continuing for 2 weeks
  • Lotemax eye drops (inflammatory conditions): one to two drops four times daily; in the first week your doctor may adjust this
  • Lotemax eye drops (post-operative): one to two drops four times daily starting 24 hours after surgery, for 2 weeks
  • Lotemax ointment: a small ribbon applied four times daily starting 24 hours after surgery, for 2 weeks
  • Lotemax gel: one to two drops four times daily starting the day after surgery, for 2 weeks
  • Lotemax SM gel: one drop three times daily starting the day after surgery, for 2 weeks

If you miss a dose of Eysuvis, take it as soon as you remember. If you use other eye drops, wait at least 5 minutes between each product. Always follow your prescriber's specific instructions.

🤒Side effects — in detail▾

Most people tolerate loteprednol etabonate eye products well, but some side effects can occur:

  • Eye pain
  • Posterior capsular opacification — clouding behind the lens after cataract surgery
  • Elevated intraocular pressure (increased pressure inside the eye)
  • Delayed wound healing after eye surgery
  • Increased risk of secondary eye infections with prolonged use

Contact your doctor right away if you notice significant eye pain, changes in your vision, increasing redness or discharge, or any sign of a new or worsening eye infection — these can be signs of a more serious problem that needs prompt attention.

⚠️Warnings & precautions▾
  • Rising eye pressure (IOP): Long-term use can raise pressure inside the eye, potentially damaging the optic nerve and leading to glaucoma. If you use this medication for 10 days or more, your eye pressure should be checked regularly.
  • Cataract formation: Corticosteroid eye drops used over time can cause posterior subcapsular cataracts (a specific type of lens clouding).
  • Infection risk: Steroids suppress the eye's immune defenses. Prolonged use raises the risk of bacterial, viral, or fungal eye infections. Fungal infections of the cornea are a particular concern with long-term use.
  • Herpes simplex: If you have a history of herpes simplex eye infection, use this medication only under close supervision — steroids can prolong or worsen the infection.
  • Delayed healing: Using steroid eye drops after cataract surgery may slow healing and increase the chance of bleb formation (fluid-filled pockets). In people with thinning of the cornea or sclera, rare perforations have occurred.
  • Contact lenses: Do not wear contact lenses during treatment with loteprednol etabonate ophthalmic gel.
🔀What it interacts with▾

The FDA label for loteprednol etabonate eye products does not specify particular drug interactions. However, there are important administration points to be aware of:

  • Other eye drops: Wait at least 5 minutes between instilling loteprednol etabonate and any other eye drops to avoid washing out the medication before it has time to work

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Viral eye infections: Do not use loteprednol etabonate if you have epithelial herpes simplex keratitis (dendritic keratitis), chickenpox (varicella), or vaccinia affecting the eye
  • Fungal or mycobacterial eye infections: This medication is contraindicated (must not be used) with these infections
  • Glaucoma or high eye pressure: Tell your doctor — this drug can raise eye pressure further
  • History of herpes simplex eye infection: Tell your doctor — steroid eye drops can reactivate or worsen this infection
  • Pregnancy: Animal studies showed birth defects at doses relevant to human use; discuss risks and benefits carefully with your doctor
  • Breastfeeding: It is not known whether this drug passes into breast milk; talk to your doctor about the risks and benefits
  • Children: Loteprednol etabonate ophthalmic gel has established safety and effectiveness in children from birth to age 11
  • Older adults: No significant differences in safety or effectiveness compared to younger patients have been found
  • Contact lens wearers: Do not wear contact lenses during your course of treatment
🔬Pharmacokinetics — how your body processes it▾

When loteprednol etabonate eye drops are applied as directed, blood levels of the drug remain below detectable limits — meaning very little, if any, is absorbed into the bloodstream. Studies with Lotemax suspension applied up to 8 times daily found that plasma concentrations of the drug and its primary inactive metabolite stayed below 1 ng/mL at all time points. The ointment form is not expected to result in higher systemic exposure than the suspension used at standard doses. This low systemic absorption is a meaningful safety advantage of ophthalmic (eye-based) corticosteroid delivery.

📦How to store it▾

Store upright at 15º to 25º C (59º to 77º F).

📄 Written from Loteprednol Etabonate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Loteprednol Etabonate — the kind of thing our pharmacy team would talk through with you at the counter.

What is loteprednol etabonate actually used for? ▾
It depends on which product you've been given. Some versions — like Alrex — treat seasonal eye allergies. Eysuvis is used short-term for dry eye disease. Others, like Inveltys and Lotemax ointment or gel, are used after eye surgery to control pain and swelling. Lotemax eye drops also treat a wider range of inflammatory eye conditions. Your pharmacist or doctor can confirm exactly what your specific product is for.
How do I use these eye drops correctly? ▾
Always wash your hands before touching your eyes or the bottle. Shake the bottle as directed — the shaking instructions are slightly different for each product, so check your label. Tilt your head back, gently pull down your lower lid, and place the drop inside the lower eyelid. If you're using other eye drops at the same time, wait at least 5 minutes between each one. Don't touch the dropper tip to your eye or any surface.
How long will I need to use this medication? ▾
That depends on your condition and which product you're using. For post-surgical use, most products are used for the first two weeks after surgery. Eysuvis for dry eye is approved only for up to two weeks of use. For inflammatory eye conditions treated with Lotemax drops, your doctor will guide you on duration — don't stop early without checking in, but also don't use it longer than directed without follow-up.
Can this medication raise my eye pressure? ▾
Yes, it can — this is one of the most important things to know about any steroid eye drop. If you use loteprednol etabonate for 10 days or more, your doctor should check your intraocular pressure (the pressure inside your eye). Unchecked high eye pressure can damage your optic nerve over time. Be sure to attend all follow-up appointments, and tell your doctor right away if you notice any changes in your vision.
Is it safe to use if I'm pregnant or breastfeeding? ▾
Animal studies did show birth defects at doses connected to human use, so this is a real concern to discuss with your doctor before using loteprednol etabonate if you're pregnant or trying to become pregnant. For breastfeeding, we don't have solid data on whether it passes into breast milk. Your doctor will help you weigh the benefits of treatment against any potential risks for your baby.
Can I wear my contact lenses while using this medication? ▾
You should not wear contact lenses during your course of treatment with loteprednol etabonate ophthalmic gel. The labeling for that product specifically advises against it. Talk to your eye doctor about when it's safe to wear your lenses again after finishing treatment.
Is Loteprednol Etabonate available over the counter? ▾
Loteprednol Etabonate is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Loteprednol Etabonate first available? ▾
Loteprednol Etabonate has been available in the United States since at least 1998, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Loteprednol Etabonate? ▾
Loteprednol Etabonate is supplied by 19 manufacturers listed in the FDA NDC Directory, including Bausch & Lomb Incorporated, Alcon Laboratories, Inc., Bausch & Lomb Americas Inc..

💬 Answers drafted from Loteprednol Etabonate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

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💊 How Loteprednol Etabonate comes

Loteprednol Etabonate is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Eye drops

In the eye
Brands Alrex Eysuvis Inveltys Lotemax
How this form is used
What it may be used for
  • Alrex is used for temporary relief of seasonal allergic conjunctivitis (eye allergy symptoms)
  • Eysuvis is used for short-term treatment (up to two weeks) of dry eye disease signs and symptoms
  • Inveltys is used for post-operative inflammation and pain following eye surgery
  • Lotemax eye drops and loteprednol etabonate ophthalmic suspension treat steroid-responsive inflammatory eye conditions and post-operative inflammation after eye surgery
Important instructions
  • Alrex: shake vigorously before use; instill one drop into the affected eye(s) four times daily
  • Eysuvis: shake for two to three seconds before use; instill one to two drops into each eye four times daily for up to two weeks; wash hands before each use
  • Inveltys: shake for one to two seconds before use; instill one to two drops into the affected eye twice daily, beginning the day after surgery and continuing for the first 2 weeks after surgery
  • If using other eye drops alongside any of these products, wait at least 5 minutes between applications
Available strengths 4 strengths
2 mg/mL 2.5 mg/mL 5 mg/mL 10 mg/mL
31 FDA-listed product records ⓘ

Eye ointment

In the eye
Brands Lotemax Lotemax SM
How this form is used
What it may be used for
  • Lotemax ointment is used for post-operative inflammation and pain following eye surgery
Important instructions
  • Lotemax ointment: wash hands before use
  • Lotemax ointment: apply a small ribbon (about half an inch) into the conjunctival sac four times daily, beginning 24 hours after surgery and continuing for the first 2 weeks after surgery
Available strengths 2 strengths
3.8 mg/g 5 mg/g
14 FDA-listed product records ⓘ

Topical suspension

On the skin
Brands Inveltys
How this form is used
What it may be used for
  • Inveltys topical suspension is indicated for post-operative inflammation and pain following eye surgery
Important instructions
  • Inveltys: shake for one to two seconds before use
  • Inveltys: instill one to two drops into the affected eye twice daily beginning the day after surgery, continuing throughout the first 2 weeks of the post-operative period
  • Inveltys: wash hands well before each use; if using other eye drops, wait at least 5 minutes between applications
Available strengths 1 strength
10 mg/mL
4 FDA-listed product records ⓘ

📊 Loteprednol Etabonate across the U.S. market

How Loteprednol Etabonate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

3
Dose forms ⓘ
19
Manufacturers
6
Brand names
62
FDA-listed product records ⓘ
1998
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (13) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bausch & Lomb Incorporated19%
Alcon Laboratories, Inc.15%
Bausch & Lomb Americas Inc.8%
Isomedix Operations Inc8%
Sun Pharmaceutical Industries, Inc.6%
Armas Pharmaceuticals Inc.6%
Other makers37%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Loteprednol Etabonate is used

A general measure of how commonly Loteprednol Etabonate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Loteprednol Etabonate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

34,076
Medicaid prescriptions filled (Q1–Q4 2025)
$10.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Loteprednol Etabonate prescribed? Of the 1,596 medications we measure, Loteprednol Etabonate ranks #710 by Medicaid prescriptions — more than 56% of them.

Where Loteprednol Etabonate ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #710 of 1,596
#705 Trospium / Xanomeline 35,066 Rx #706 Furosemide Injection 34,727 Rx #707 Vedolizumab Injection 34,599 Rx #708 Iron Dextran Injection 34,405 Rx #709 Penicillin G (Potassiu... 34,354 Rx #710 Loteprednol Ophthalmic 34,076 Rx #711 Loteprednol Etabonate 34,076 Rx #712 Zaleplon 33,889 Rx #713 Ampicillin 33,801 Rx #714 Gentamicin Injection 33,521 Rx #715 Benralizumab Injection 33,442 Rx

Utilization by Loteprednol Etabonate product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 5 mg/mL ophthalmic suspension is the most-dispensed Loteprednol Etabonate product — about 41% of these Medicaid prescriptions.

loteprednol etabonate 5 MG/ML Ophthalmic Suspension Most dispensed

14,132 Medicaid prescriptions (Q1–Q4 2025) 41% of Loteprednol Etabonate prescriptions shown $2.7M gross reimbursement (before rebates) ≈ $192 per prescription (gross)

Summed across the 13 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311382

loteprednol etabonate 2.5 MG/ML Ophthalmic Suspension

8,539 Medicaid prescriptions (Q1–Q4 2025) 25% of Loteprednol Etabonate prescriptions shown $4.3M gross reimbursement (before rebates) ≈ $508 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2464838

loteprednol etabonate 2 MG/ML Ophthalmic Suspension

5,454 Medicaid prescriptions (Q1–Q4 2025) 16% of Loteprednol Etabonate prescriptions shown $1.8M gross reimbursement (before rebates) ≈ $324 per prescription (gross)

Summed across the 5 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311381

loteprednol etabonate 0.005 MG/MG Ophthalmic Gel

3,080 Medicaid prescriptions (Q1–Q4 2025) 9% of Loteprednol Etabonate prescriptions shown $508,596 gross reimbursement (before rebates) ≈ $165 per prescription (gross)

Summed across the 4 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1312625

loteprednol etabonate 0.005 MG/MG Ophthalmic Ointment

1,814 Medicaid prescriptions (Q1–Q4 2025) 5% of Loteprednol Etabonate prescriptions shown $689,545 gross reimbursement (before rebates) ≈ $380 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1099500

loteprednol etabonate 0.0038 MG/MG Ophthalmic Gel

951 Medicaid prescriptions (Q1–Q4 2025) 3% of Loteprednol Etabonate prescriptions shown $249,853 gross reimbursement (before rebates) ≈ $263 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2118537

loteprednol etabonate 10 MG/ML Ophthalmic Suspension

106 Medicaid prescriptions (Q1–Q4 2025) <1% of Loteprednol Etabonate prescriptions shown $31,617 gross reimbursement (before rebates) ≈ $298 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2055281

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Loteprednol Etabonate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 26 of 69 listed Loteprednol Etabonate NDCs with Medicaid activity.

🔍 Compare Loteprednol Etabonate products

A representative set of FDA-listed product records for Loteprednol Etabonate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 62 of 62 products — FDA National Drug Code Directory. See every product, package size and price: browse all 62 Loteprednol Etabonate NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Loteprednol Etabonate RxCUI 52177 3 dose forms · 7 strengths
  1. Dose form (SCDF) Ophthalmic Gel RxCUI 1312624 In current FDA listings
    Clinical drug / strength (SCD) 0.0038 MG/MG RxCUI 2118537 0.005 MG/MG RxCUI 1312625
  2. Dose form (SCDF) Ophthalmic Ointment RxCUI 1099499 In current FDA listings
    Clinical drug / strength (SCD) 0.005 MG/MG RxCUI 1099500
  3. Dose form (SCDF) Ophthalmic Suspension RxCUI 375144 In current FDA listings
    Clinical drug / strength (SCD) 2 MG/ML RxCUI 311381 2.5 MG/ML RxCUI 2464838 5 MG/ML RxCUI 311382 10 MG/ML RxCUI 2055281

Look up RxCUI 52177 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Lotemax Inveltys Alrex Eysuvis Lotemax SM

🏭 Manufacturers & labelers

Bausch & Lomb Incorporated 12 Alcon Laboratories, Inc. 9 Bausch & Lomb Americas Inc. 5 Isomedix Operations Inc 5 Sun Pharmaceutical Industries, Inc. 4 Armas Pharmaceuticals Inc. 4 Amneal Pharmaceuticals NY LLC 3 Sentiss Pharmaceuticals LLC 3 Padagis US LLC 3 Akorn 2 NorthStar RxLLC 2 Industriale Chimica s.r.l. 2 Farmabios S.p.A. 2 Lupin Pharmaceuticals, Inc. 1 Oceanside Pharmaceuticals 1 Curia Spain S.A.U. 1 Sportpharm LLC 1 Aarti Pharmalabs Limited 1 Zach System Sa 1

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 11, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Loteprednol Etabonate.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Loteprednol Etabonate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
26
NDC products indexed
62
Distinct labelers/manufacturers represented
19
Linked representative label ⓘ
Alcon Laboratories, Inc.
Linked label effective
Mar 11, 2025
Composite sections available
23
Linked SPL Set ID
a2169d82-4275-4ab6-a1c3-c274080b815c
Linked SPL Document ID
db147c65-ed03-4af5-af1f-86b9ff51148a
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 26 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Alcon Laboratories, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.