Prescription and over-the-counter medicine
Cromolyn Brand names: Gastrocrom; first approved as Intal
Cromolyn (Gastrocrom) is a prescription and over-the-counter medicine with an FDA approval on record since 1982. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.349 per mL (Cromolyn 100 mg/5 mL oral conc) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the cromolyn FDA label on DailyMed (effective February 20, 2025, Sandoz Inc); the NDA 18596 record on Drugs@FDA; every cromolyn label on DailyMed.
Highlights of the record
FDA label of February 20, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
Forms and strengths
- 5.2 mg
- 20 mg/2ml
- 20 mg/ml
- 40 mg/ml
- 100 mg/5ml
Solution/ drops; solution (concentrate); spray (metered); solution; liquid.
On the market
- Earliest approval on file
- May 28, 1982 Intal, King Pharms Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 24 first April 26, 1994; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 10 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.349 per mL Cromolyn 100 mg/5 mL oral conc
- Shortage (FDA)
- None current 4 past records
- Recalls by its makers (FDA)
- 3 since 2022 0 Class I among all firms' recalls; latest July 21, 2023
- FAERS reports
- 3,585 through July 30, 2026
What is cromolyn used for?
From the label: indications and usageCromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
Conditions named in the indications of cromolyn's FDA labels, with every medicine labeled for each:
From other cromolyn labelsAsthma: INDICATIONS AND USAGE Cromolyn sodium inhalation solution USP is a prophylactic agent indicated in the management of patients with bronchial asthma.
Allergies: Uses to prevent and relieve nasal symptoms of hay fever and other nasal allergies: runny/itchy nose sneezing allergic stuffy nose
FDA pharmacologic class: Mast Cell Stabilizer.
Source: FDA drug label (Cromolyn Sodium), Sandoz Inc, effective February 20, 2025 (SPL set b32851c3-cd97-4be4-a09c-1deab1d6966b), via openFDA; the full label on DailyMed
Is there a generic for cromolyn (Gastrocrom)?
The FDA approved the first generic cromolyn on April 26, 1994. 24 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cromolyn from 10 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1982 earliest approval on file
- 1994 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cromolyn (Gastrocrom)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.349 per mL (Cromolyn 100 mg/5 mL oral conc). The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cromolyn 100 mg/5 mL oral conc (generic)
- Gastrocrom 100 mg/5 mL conc (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cromolyn 100 mg/5 mL oral conc | Generic | $0.349 per mL | n/a | n/a |
| Cromolyn 20 mg/2 mL neb solution | Generic | $0.963 per mL | n/a | +70% |
| Cromolyn 4% eye drops | Generic | $0.595 per mL | n/a | no change |
| Gastrocrom 100 mg/5 mL conc | Brand | $2.43 per mL | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is cromolyn in shortage?
No cromolyn presentation is listed as limited or unavailable in the FDA Drug Shortage Database (read October 8, 2026); it keeps 4 current entries listed as available (updated October 5, 2026). ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 16571-600-96) | Rising Pharma Holdings, Inc. | Current | September 1, 2026 |
| Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 42571-132-52) | Micro Labs LTD | Current | October 3, 2026 |
| Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 81665-104-96) | Ailex Pharmaceuticals | Current | September 30, 2026 |
| Gastrocrom, Concentrate, 20 mg/1 mL (NDC 0037-0678-96) | Mylan Specialty, a Viatris Company | Current | October 5, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has cromolyn been recalled?
The FDA's Enforcement Report lists 3 recalls naming cromolyn since 2022: 0 Class I (the most serious), 3 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 21, 2023 | Class II | The Ritedose Corporation | CGMP deviation: product released prior to supplier approval. |
| April 26, 2023 | Class II | Akorn, Inc. | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| October 13, 2022 | Class II | Akorn, Inc. | CGMP Deviations: |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cromolyn label say about other medicines?
The cromolyn label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name cromolyn. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Isoproterenol | drug interactions | 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). |
Other labels that name cromolyn
Source: FDA drug label (Cromolyn Sodium), Sandoz Inc, effective February 20, 2025 (SPL set b32851c3-cd97-4be4-a09c-1deab1d6966b), via openFDA; the full label on DailyMed
What do FAERS reports show for cromolyn?
The FDA Adverse Event Reporting System holds 3,585 reports that list cromolyn among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 48 are coded as a death and 433 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2020 (1,119, against a median of 165 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cromolyn?
9 other medicines are given the same way (oral) and in the same FDA class as cromolyn or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dexamethasone | Asthma | 41 labelers | $0.193 per tablet 4 mg tablet | In shortage |
| Montelukast | Asthma | 36 labelers | $0.0419 per tablet 10 mg tablet | A presentation being discontinued |
| Theophylline | Asthma | 26 labelers | $0.330 per tablet 300 mg tablet | No current entry |
| Albuterol | Asthma | 14 labelers | $0.288 per tablet 2 mg tablet | Resolved |
| Budesonide | Asthma | 14 labelers | $0.498 per capsule 3 mg capsule | No current entry |
| Zafirlukast | Asthma | 5 labelers | $0.623 per tablet 20 mg tablet | No current entry |
| Zileuton | Asthma | 5 labelers | $2.05 per tablet 600 mg tablet | No current entry |
| Ephedrine | Asthma | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does cromolyn compare with medicines for the same use?
2 side-by-side pages set cromolyn beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to cromolyn
- 9 medicines for the same use
- Other mast cell stabilizers
- the pharmacologic class, with prices and generics
- Cromolyn side effects
- the label's list beside FAERS reports
- Cromolyn shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other