A clinical briefing on the Cromolyn Sodium oral solution shortage for providers. Timeline, prescribing implications, alternatives, and patient access tools.
Cromolyn Sodium oral concentrate (100 mg/5 mL) has been on the FDA's active drug shortage list since mid-2023. For prescribers who manage patients with mastocytosis, mast cell activation syndrome (MCAS), and related conditions, this shortage has created significant treatment disruptions.
This briefing summarizes the current state of the shortage, its clinical implications, and actionable steps providers can take to support patient access.
Understanding the timeline helps frame the scope of this issue:
The intermittent nature of this shortage creates several clinical challenges:
Patients who abruptly lose access to Cromolyn may experience symptom flares including GI disturbance, flushing, urticaria, and in severe cases, anaphylactoid reactions. The median time patients reported being without Cromolyn during the 2023 shortage was 30 days (TMS survey data).
The unpredictability of supply has led some patients to ration their medication, skip doses, or stockpile when supply is available — none of which are optimal from an adherence standpoint.
For newly diagnosed patients, the inability to trial Cromolyn can delay treatment optimization and make it harder to establish a baseline response to mast cell stabilizer therapy.
As of early 2026, the manufacturer landscape is as follows:
The nasal spray formulation (NasalCrom, OTC) and ophthalmic preparations are generally unaffected by this shortage.
The shortage has created cost pressures for patients:
Insurance coverage varies. Some plans require prior authorization or step therapy (typically trying antihistamines first). Given the shortage, some insurers have been more flexible with PA requirements — it may be worth an appeal if initial coverage is denied.
Medfinder offers real-time pharmacy availability data for shortage medications. Providers can direct patients to check Cromolyn availability at nearby pharmacies, or use the tool themselves during patient encounters to identify stocked locations.
Compounding pharmacies can prepare Cromolyn Sodium in capsule form (100 mg or 200 mg) using bulk powder. When writing prescriptions during the shortage, consider adding "compounding acceptable" to give pharmacies flexibility. Notable compounding pharmacies serving mast cell patients nationally include those recommended by the Mast Cell Disease Society.
When Cromolyn is truly unavailable, consider these evidence-based alternatives:
For a patient-facing comparison, you may share: Alternatives to Cromolyn If You Can't Fill Your Prescription.
Omnivium Pharmaceuticals changed its NDC for Cromolyn Sodium to 81665-0104-96. If a patient reports that their pharmacy says Cromolyn is "discontinued," this may be the cause. Advise the pharmacy to search the new NDC or contact their wholesaler directly.
There is no confirmed resolution date for this shortage. The fundamental issues — limited API supply, high demand, and a small manufacturer base — are structural and unlikely to resolve quickly. Providers should plan for continued intermittent availability through at least 2026.
Proactive steps include:
The Cromolyn Sodium shortage is a significant challenge for providers managing mast cell patients. By staying informed about the supply landscape, having alternative protocols ready, and leveraging tools like Medfinder, you can help minimize treatment disruptions for your patients.
For a practical guide on helping patients locate Cromolyn, see How to Help Your Patients Find Cromolyn in Stock: A Provider's Guide. For patient-facing content you can share, see our Cromolyn Shortage Update for Patients.
You focus on staying healthy. We'll handle the rest.
Try Medfinder Concierge FreeMedfinder's mission is to ensure every patient gets access to the medications they need. We believe this begins with trustworthy information. Our core values guide everything we do, including the standards that shape the accuracy, transparency, and quality of our content. We’re committed to delivering information that’s evidence-based, regularly updated, and easy to understand. For more details on our editorial process, see here.
%2C%20Color%3DOriginal.png)
