Two medicines, side by side
Cromolyn vs montelukast
Cromolyn and montelukast are both labeled for asthma and allergies. Drugs@FDA records approvals of cromolyn since 1982 and of montelukast since 1998. Pharmacies paid $0.349 per mL (Cromolyn 100 mg/5 mL oral conc) and $0.0419 per montelukast sod 10 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, cromolyn is a mast cell stabilizer and montelukast a leukotriene receptor antagonist.
Check it at the source: the cromolyn FDA label on DailyMed (effective February 20, 2025); the montelukast FDA label on DailyMed (effective April 30, 2025).
Highlights of the cromolyn record
Cromolyn (Gastrocrom) · label of February 20, 2025
Used for
From the label: indicationsCromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
On the market
- Earliest approval on file
- May 28, 1982
- Generic labelers
- 10 labelers
- Pharmacy cost
- $0.349 per mL
Supply and safety
- Shortage
- Listed; available
- Recalls
- 3
Highlights of the montelukast record
Montelukast (Singulair) · label of April 30, 2025
SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of SINGULAIR. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with SINGULAIR use are currently not well understood [see Warnings and Precautions (5.1) ].
Used for
From the label: indicationsSINGULAIR is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). […]
On the market
- Earliest approval on file
- February 20, 1998
- Generic labelers
- 36 labelers
- Pharmacy cost
- $0.0419 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 11
Source: FDA drug labels via openFDA (Cromolyn label of February 20, 2025, Montelukast label of April 30, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do cromolyn and montelukast differ on the record?
In FDA's classes, cromolyn is a mast cell stabilizer and montelukast a leukotriene receptor antagonist.
Only the montelukast label carries a boxed warning.
Generics: cromolyn since 1994; montelukast since 2012 (Drugs@FDA).
| Cromolyn | Montelukast | |
|---|---|---|
| Labeled for | Asthma, Allergies | Asthma, Allergies |
| Pharmacologic class | Mast Cell Stabilizer | Leukotriene Receptor Antagonist |
| How it works (label) | n/a | The cysteinyl leukotrienes (LTC 4 , LTD 4 , LTE 4 ) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene (CysLT) receptors. |
| Half-life (label) | n/a | In several studies, the mean plasma half-life of montelukast ranged from 2.7 to 5.5 hours in healthy young adults. |
| Earliest approval on file (Drugs@FDA) | May 28, 1982 | February 20, 1998 |
| First generic approved | April 26, 1994 | August 3, 2012 |
| Generic labelers (NDC) | 10 labelers | 36 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.349 per mL (Cromolyn 100 mg/5 mL oral conc) | $0.0419 per tablet (Montelukast sod 10 mg tablet) |
| 12-month price change | n/a | -20% |
| Boxed warning | No | Yes |
| Shortage now | Listed; available | A presentation being discontinued |
| Recalls recorded | 3 | 11 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 3,585 | 174,997 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to cromolyn
- every medicine labeled for the same conditions