FDA label
What is cromolyn used for?
The FDA-approved uses of cromolyn, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.”
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Cromolyn Sodium, solution/ drops
Indications and Usage, quoted from the label by Sandoz Inc (ANDA075282). Cross-references to other label sections are left out.
Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
Source: DailyMed label, set id b32851c3-cd97-4be4-a09c-1deab1d6966b, version 7, effective February 20, 2025. NDC 61314-237, one of 4 listings for this product.
Cromolyn Sodium, solution, concentrate
Indications and Usage, quoted from the label by Omnivium Pharmaceuticals LLC (ANDA209264). Cross-references to other label sections are left out.
Cromolyn Sodium Oral Solution (Concentrate) is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.
Source: DailyMed label, set id a742664b-265e-49f9-9744-d04e1fb620ae, version 2, effective January 13, 2026. NDC 81665-104, one of 3 listings for this product.
Cromolyn Sodium, solution
Indications and Usage, quoted from the label by Teva Pharmaceuticals USA, Inc. (ANDA075271). Cross-references to other label sections are left out.
Cromolyn sodium inhalation solution USP is a prophylactic agent indicated in the management of patients with bronchial asthma.
In patients whose symptoms are sufficiently frequent to require a continuous program of medication, cromolyn sodium inhalation solution USP is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION ). The effect of cromolyn sodium is usually evident after several weeks of treatment, although some patients show an almost immediate response.
In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., cromolyn sodium should be given shortly before exposure to the precipitating factor (see DOSAGE AND ADMINISTRATION ).
Source: DailyMed label, set id 8fe37a7a-edd6-4733-bb7e-e01c1906aeba, version 9, effective December 14, 2023. NDC 0172-6406, one of 1 listing for this product.
Questions
What is cromolyn used for?
The FDA label says: “Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.”
What drug class is cromolyn?
FDA lists cromolyn in the Mast Cell Stabilizer established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.