Cromolyn Ophthalmic
Cromolyn ophthalmic is an eye drop used to treat vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis — seasonal allergic eye conditions that cause itching, tearing, and eye discomfort.
🧬 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 6 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 →
📖 Cromolyn Ophthalmic: Patient Information Guide
A plain-language walkthrough of Cromolyn Ophthalmic — 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▾
Cromolyn sodium ophthalmic solution is approved for allergic eye conditions that tend to recur seasonally. All three supported uses apply specifically to Cromolyn Sodium ophthalmic solution 4%:
- Vernal keratoconjunctivitis — a recurring seasonal allergy affecting both the conjunctiva (eye's outer lining) and the cornea
- Vernal conjunctivitis — seasonal allergic inflammation of the conjunctiva
- Vernal keratitis — seasonal allergic inflammation of the cornea
⚙️How it works▾
Cromolyn sodium stabilizes mast cells — immune cells that sit in the tissues of your eye and release irritating chemicals when they encounter allergens. Normally, those cells release histamine and another substance called SRS-A (slow-reacting substance of anaphylaxis), which drive itching, tearing, and redness. Cromolyn sodium blocks the process that triggers that release, so those chemicals never get out in the first place. It has no direct antihistamine or anti-inflammatory effect on its own — it simply prevents the allergic cascade from starting.
💊How it's taken▾
Cromolyn Sodium eye drops are applied directly to the eye. The usual approach is 1 or 2 drops in each eye, four to six times daily, spaced out at regular intervals throughout the day. Consistent timing matters — the drops are most effective when used on a set schedule rather than only when symptoms flare.
- Symptoms like itching and tearing often improve within a few days, but some people need up to six weeks of treatment for full benefit
- Once improvement is established, continue using the drops for as long as your prescriber directs to keep symptoms under control
- If you miss a dose, take it as soon as you remember and then return to your regular schedule — do not double up
🤒Side effects — in detail▾
The most common side effect is a brief stinging or burning sensation right after the drops go in — this is generally harmless and usually fades quickly. Other reported effects include:
- Eye irritation or redness (conjunctival injection)
- Watery or itchy eyes
- Dryness around the eye
- Puffy eyes
- Styes (small eyelid bumps)
Rarely, serious allergic reactions have occurred, including trouble breathing, swelling, or a rash. If any of these happen, stop using the drops and get medical help right away.
⚠️Warnings & precautions▾
- Serious allergic reactions are rare but possible — if you experience breathing difficulty, facial or eye swelling, or a rash after using the drops, seek emergency care immediately
- Do not use Cromolyn Sodium eye drops if you are allergic to cromolyn sodium or to any ingredient in the solution
- The drops require regular, consistent use to be effective — skipping doses or using them only occasionally will reduce how well they work
- If a corticosteroid eye medication is also prescribed, your doctor will guide you on using both together safely
🔀What it interacts with▾
The FDA label for Cromolyn Sodium ophthalmic solution does not identify specific drug, food, or substance interactions to be aware of. Always tell your doctor and pharmacist about all eye drops and other medications you are using.
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▾
- Do not use these drops if you have a known allergy to cromolyn sodium or any component of the solution
- Tell your doctor about all eye conditions and any other eye medications — prescription or over-the-counter — that you are currently using
- Inform your prescriber if you are pregnant, planning to become pregnant, or breastfeeding so they can weigh the benefits and risks with you
📡Pharmacodynamics — effects in the body▾
Cromolyn sodium prevents sensitized mast cells in the eye from degranulating — meaning it stops them from releasing the chemical mediators (histamine and SRS-A) that cause the redness, itching, tearing, and discharge of allergic eye disease. It does not constrict blood vessels, block histamine receptors directly, or reduce existing inflammation on its own. Its benefit comes from preventing the allergic response from being triggered in the first place.
🔬Pharmacokinetics — how your body processes it▾
Cromolyn sodium is very poorly absorbed when applied to the eye. In animal studies, less than 0.07% of the administered dose reached the bloodstream, and in human volunteers, approximately 0.03% was absorbed following eye administration. Only trace amounts (less than 0.01%) penetrate into the aqueous humor (the fluid inside the eye), and those trace amounts clear from the eye within 24 hours after treatment stops.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F) . Protect from light-store in original carton. Keep out of reach of children.
📄 Written from Cromolyn Ophthalmic’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 Cromolyn Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this eye drop treating — is it just regular eye allergies? ▾
How long before these drops actually start helping? ▾
My eyes sting when I put the drops in. Is that normal? ▾
Can I stop using them once my eyes feel better? ▾
Is there anything I should watch for that would mean I need to call for help right away? ▾
Can I use these drops alongside other eye medications my doctor prescribed? ▾
Is Cromolyn Ophthalmic available over the counter? ▾
When was Cromolyn Ophthalmic first available? ▾
Who makes Cromolyn Ophthalmic? ▾
💬 Answers drafted from Cromolyn Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Cromolyn Ophthalmic comes
Cromolyn Ophthalmic is available in 1 form. 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
How this form is used
- Cromolyn Sodium ophthalmic solution is used to treat vernal keratoconjunctivitis
- Cromolyn Sodium ophthalmic solution is used to treat vernal conjunctivitis
- Cromolyn Sodium ophthalmic solution is used to treat vernal keratitis
- Cromolyn Sodium eye drops are instilled as 1 or 2 drops in each eye, four to six times a day at regular intervals
- Cromolyn Sodium eye drops must be used on a consistent schedule — regular timing is key to how well they work
- Cromolyn Sodium eye drops may be used alongside corticosteroid eye treatments if your doctor prescribes them together
- Continue using Cromolyn Sodium eye drops for as long as your doctor directs, even after symptoms improve
📊 Cromolyn Ophthalmic across the U.S. market
How Cromolyn Ophthalmic 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Cromolyn Ophthalmic is used
A general measure of how commonly Cromolyn Ophthalmic 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 Cromolyn Ophthalmic 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.
How commonly is Cromolyn Ophthalmic prescribed? Of the 1,596 medications we measure, Cromolyn Ophthalmic ranks #560 by Medicaid prescriptions — more than 65% of them.
Utilization by Cromolyn Ophthalmic 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.
cromolyn sodium 40 MG/ML Ophthalmic Solution
Summed across the 1 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 831109
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 Cromolyn Ophthalmic, 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 1 of 9 listed Cromolyn Ophthalmic NDCs with Medicaid activity.
🔍 Compare Cromolyn Ophthalmic products
A representative set of FDA-listed product records for Cromolyn Ophthalmic — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| 40 mg/mL | Ophthalmic | A-S Medication Solutions × 5 listings | ANDA | View NDC → |
| 40 mg/mL | Ophthalmic | Akorn | ANDA | View NDC → |
| 40 mg/mL | Ophthalmic | Preferred Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 40 mg/mL | Ophthalmic | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| 40 mg/mL | Ophthalmic | RPK Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 40 mg/mL | Ophthalmic | Sandoz Inc × 2 listings | ANDA | View NDC → |
Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Cromolyn Ophthalmic NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Cromolyn Ophthalmic — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Cromolyn Ophthalmic in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Cromolyn Ophthalmic went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 42612 8 dose forms · 8 strengths
-
Dose form (SCDF) Inhalation Powder RxCUI 2108327No current FDA listingClinical drug / strength (SCD) sodium 20 MGRxCUI 309548 -
Dose form (SCDF) Inhalation Solution RxCUI 2108316No current FDA listingClinical drug / strength (SCD) sodium 10 MG/MLRxCUI 831246 -
Dose form (SCDF) Metered Dose Inhaler RxCUI 746181No current FDA listing -
Dose form (SCDF) Metered Dose Nasal Spray RxCUI 1797850No current FDA listingClinical drug / strength (SCD) sodium 5.2 MG/ACTUATRxCUI 1797851 -
Dose form (SCDF) Nasal Spray RxCUI 378374No current FDA listingClinical drug / strength (SCD) sodium 5.2 MG/ACTUATRxCUI 849548 -
Dose form (SCDF) Ophthalmic Solution RxCUI 378379In current FDA listings -
Dose form (SCDF) Oral Capsule RxCUI 378381No current FDA listingClinical drug / strength (SCD) sodium 100 MGRxCUI 831263 -
Dose form (SCDF) Oral Solution RxCUI 378378No current FDA listingClinical drug / strength (SCD) sodium 20 MG/MLRxCUI 831261
Look up RxCUI 42612 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.
📦 Supply & shortage status
Whether Cromolyn Ophthalmic is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Cromolyn Ophthalmic belongs to the Mast Cell Stabilizer class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 6 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.
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. Akorn 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.