Molecule
Cromolyn is a mast cell stabilizer indicated in the management of patients with mastocytosis. It is available as eye drops, oral concentrate and oral liquid for ophthalmic and intrabronchial use. MedsAcross supplies Cromolyn for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
GASTROCROM 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: US FDA prescribing information
NOT FOR INHALATION OR INJECTION. SEE DIRECTIONS FOR USE. The usual starting dose is as follows: Adults and Adolescents (13 Years and Older) Two ampules four times daily, taken one-half hour before meals and at bedtime. Children 2-12 Years One ampule four times daily, taken one-half hour before meals and at bedtime. Pediatric Patients Under 2 Years Not recommended. If satisfactory control of symptoms is not achieved within two to three weeks, the dosage may be increased but should not exceed 40 mg/kg/day. Patients should be advised that the effect of GASTROCROM therapy is dependent upon its administration at regular intervals, as directed. Maintenance Dose Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology. To prevent relapses, the dosage should be maintained.
Source: US FDA prescribing information
GASTROCROM is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
Source: US FDA prescribing information
The recommended dosage should be decreased in patients with decreased renal or hepatic function. Severe anaphylactic reactions may occur rarely in association with cromolyn sodium administration.
Source: US FDA prescribing information
Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received GASTROCROM during clinical studies were headache and diarrhea, each of which occurred in 4 of the 87 patients. Pruritus, nausea, and myalgia were each reported in 3 patients and abdominal pain, rash, and irritability in 2 patients each. One report of malaise was also recorded. Other Adverse Events: Additional adverse events have been reported during studies in other clinical conditions and from worldwide postmarketing experience. In most cases the available information is incomplete and attribution to the drug cannot be determined.
Source: US FDA prescribing information
Drug Interaction During Pregnancy In pregnant mice, cromolyn sodium alone did not cause significant increases in resorptions or major malformations at subcutaneous doses up to 540 mg/kg (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis). Isoproterenol alone increased both resorptions and major malformations (primarily cleft palate) at a subcutaneous dose of 2.7 mg/kg (approximately 7 times the maximum recommended daily inhalation dose in adults on a mg/m 2 basis). The incidence of major malformations increased further when cromolyn sodium at a subcutaneous dose of 540 mg/kg was added to isoproterenol at a subcutaneous dose of 2.7 mg/kg. No such interaction was observed in rats or rabbits.
Source: US FDA prescribing information
Store ampules in foil pouch until ready for use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Cromolyn, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Cromolyn 40 mg/mL eye dropsOphthalmicGeneric name | — | US FDA | Available on request |
| Cromolyn 100 mg/5 mL oral concentrateOralGeneric name | — | US FDA | Available on request |
| Cromolyn 20 mg/2 mL solutionIntrabronchialGeneric name | — | US FDA | Available on request |
| Gastrocrom 20 mg/mL oral liquidOral | Viatris Specialty | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 28 May 1982 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Cromolyn in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 4 presentations of Cromolyn and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Cromolyn, including Gastrocrom.
Yes. The US FDA first approved Cromolyn on 28 May 1982, according to Drugs@FDA.
No listed presentation of Cromolyn is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Cromolyn is classified under ATC code A07EB01 (Cromolyn).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.