Quick answers
- What is Cromolyn sodium used for?
- The FDA-approved label (Gastrocrom, Viatris Specialty LLC, June 26, 2024) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cromolyn sodium have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cromolyn sodium?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 19, 2026). Ask your pharmacist about alternatives.
- Has Cromolyn sodium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cromolyn sodium?
- 9 companies list prescription products of Cromolyn sodium in the FDA NDC Directory, including Micro Labs Limited, A-S Medication Solutions and Sandoz Inc.
What Cromolyn sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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.
— FDA label: Gastrocrom, Viatris Specialty LLC, effective June 26, 2024. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution/ drops · Solution, concentrate · Solution · Liquid |
|---|---|
| Route | Oral · Ophthalmic · Intrabronchial |
| Prescription products | 9 in the FDA NDC Directory |
| Brand names | Gastrocrom |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| cromolyn sodium 100 mg/5 mL solution, concentrate | Generic | $0.3681 per mL |
| cromolyn sodium 20 mg/2 mL solution | Generic | $0.9499 per mL |
| cromolyn sodium 20 mg/mL liquid | Brand: Gastrocrom | $2.44 per mL |
| cromolyn sodium 40 mg/mL solution/ drops | Generic | $0.5913 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Micro Labs Limited1 product
- A-S Medication Solutions1 product
- Sandoz Inc1 product
- Omnivium Pharmaceuticals LLC.1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Proficient Rx LP1 product
- Preferred Pharmaceuticals Inc.1 product
- Rising Pharma Holdings, Inc.1 product
- Viatris Specialty LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020479 GASTROCROM | Viatris Specialty | February 29, 1996 | 4, latest February 13, 2003 2003: Labeling · 2000: Labeling · 1999: Manufacturing (CMC) |
Generic approvals (5)
- ANDA075282Sandoz · June 16, 1999
- ANDA075271Teva Pharms · January 18, 2000
- ANDA202583Rising · October 27, 2011
- ANDA202745Micro Labs Ltd India · April 4, 2013
- ANDA209264Ailex Pharms LLC · October 16, 2017
Shortage status
Current shortage · updated October 19, 2026 · first posted November 3, 2023
| Product | Gastrocrom, Concentrate, 20 mg/1 mL (NDC 0037-0678-96) |
|---|---|
| Availability | Available |
| Company | Mylan Specialty, a Viatris Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 831109, 831246, 831261, 831269 |
|---|---|
| SPL set ID of the quoted label | 00623958-a8fe-47d1-a0d2-0aa4e2f7966e |
| FDA labels (SPL) | 8 |
| FDA applications | NDA020479, 5 ANDA |
| Active ingredients (FDA) | CROMOLYN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Gastrocrom, Viatris Specialty LLC, effective June 26, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →