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CROMOLYN SODIUM

Generic: Cromolyn Sodium

Verified·Apr 23, 2026
NDC
68788-8490
RxCUI
831109
Route
OPHTHALMIC
ICD-10 indication
J45.909

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About CROMOLYN SODIUM

What is this medication? Cromolyn sodium is a type of medication known as a mast cell stabilizer. It works by preventing the release of natural substances in the body, such as histamine, that cause inflammation and allergic reactions. This medication is primarily used as a preventive treatment rather than a rescue medicine, meaning it must be taken regularly to be effective at keeping symptoms under control before they start. Doctors prescribe this medication for several different conditions depending on the form it takes. In its inhaled or nasal forms, it is used to manage bronchial asthma and allergic rhinitis. The oral liquid form is typically used to treat systemic mastocytosis or certain food allergies, while the ophthalmic drops help relieve itchy or red eyes caused by seasonal allergies. Because it is a maintenance drug, patients should follow their prescribed schedule closely even when they feel well.

Copay & patient assistance

  • Patient Copay Amount: $0 (Medicines are provided for free)
  • Maximum Annual Benefit Limit: Not Publicly Available
  • Core Eligibility Restrictions: Patients must have a demonstrated financial need and must be located in the United States. Specific eligibility instructions are provided on the application for each individual medicine.
  • RxBIN, PCN, and Group numbers: Not Publicly Available

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Prescribing information

From the FDA-approved label for CROMOLYN SODIUM. Official source: DailyMed (NLM) · Label effective Apr 1, 2026

Indications and usage
INDICATIONS AND USAGE Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
Dosage and administration
DOSAGE AND ADMINISTRATION The dose is 1 or 2 drops in each eye 4 to 6 times a day at regular intervals. One drop contains approximately 1.6 mg cromolyn sodium. Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed. Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement. If required, corticosteroids may be used concomitantly with Cromolyn Sodium Ophthalmic Solution USP, 4%.
Contraindications
CONTRAINDICATIONS Cromolyn Sodium Ophthalmic Solution USP, 4% is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients.
Adverse reactions
ADVERSE REACTIONS The most frequently reported adverse reaction attributed to the use of cromolyn sodium ophthalmic solution, on the basis of reoccurrence following readministration, is transient ocular stinging or burning upon instillation. The following adverse reactions have been reported as infrequent events. It is unclear whether they are attributable to the drug: Conjunctival injection; watery eyes; itchy eyes; dryness around the eye; puffy eyes; eye irritation; and styes. Immediate hypersensitivity reactions have been reported rarely and include dyspnea, edema and rash.
Use in pregnancy
Pregnancy

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Medicare Part D coverage

How CROMOLYN SODIUM appears across Medicare Part D plan formularies nationally. Source: CMS monthly Prescription Drug Plan file (2026-04-30).

Covered by plans

80%

4,417 of 5,509 plans

Most common tier

Tier 3

On 33% of covering formularies

Prior authorization required

58%

of covering formularies

TierFormularies on this tierShare
Tier 1 (preferred generic)79
24%
Tier 2 (generic)102
31%
Tier 3 (preferred brand)109
33%
Tier 4 (non-preferred brand)39
12%

Step therapy: 0% of formularies

Quantity limits: 1% of formularies

Coverage breadth: 329 of 65 formularies

How to read this:plans on the same formulary share tier + PA rules. Your specific plan's copay depends on (a) the tier above, (b) your plan's cost-share for that tier, (c) whether you're in the initial coverage phase or past the 2026 $2,000 out-of-pocket cap. For your exact plan, check its Summary of Benefits or log in to your Medicare.gov account. Copay cards don't apply to Medicare (federal law).

Prior authorization & coverage

PayerPAStep therapyCopay tier

Medicare Part D

Medicare Part D

Medicare Part D

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How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.

Rare-disease navigation (specialists, trials, patient communities)

CROMOLYN SODIUM treats a rare condition. For in-depth disease pages on our sister site:

UniteRare.org is our sister site for rare-disease navigation — same editorial team, same accuracy standards.