Cromolyn Sodium Concentrate shortage
Cromolyn Sodium Concentrate is currently listed in shortage by the FDA. The FDA lists 6 affected products. The reported reason: Other. This page was last refreshed from FDA data on Oct 3, 2026.
Cromolyn sodium concentrate is in shortage, but all four manufacturers reporting the shortage still list available supply in both the 20 mg/1 mL and 100 mg/5 mL strengths. Some supply remains in the distribution chain, though Ailex Pharmaceuticals has stopped making it.
Don’t stop or change your therapy on your own — ask your pharmacist about other manufacturers (see options) and your prescriber about a long-term plan.
Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →What’s in shortage — at a glance
These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Cromolyn Sodium Concentrate. Other makers that haven’t reported a problem are shown in the green card below.
Shortage timeline
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Sep 30, 2026Currently in shortage6 of 6 products affected.
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Sep 17, 2026FDA refreshed this shortage record1 product updated.
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Sep 16, 2026FDA refreshed this shortage record1 product updated.
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Sep 1, 2026FDA refreshed this shortage record1 product updated.
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Nov 3, 2023First reported to the FDA6 products first listed.
Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.
What exactly is on backorder — by manufacturer
Manufacturer: Ailex Pharmaceuticals 📞 Distributed by Omnivium Pharmaceuticals LLC (888) 807-9195 or [email protected] 3 NDCS click to expand
| Status | NDC / product | Strength | Availability | Related information | Reason |
|---|---|---|---|---|---|
| Current | Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 76204-025-96) | — | Limited Availability | No longer manufactured, some supplies still available in supply chain. Distributed by Ritedose Pharmaceuticals, LLC (855) 806 3300 | Other |
| Current | Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 69784-200-96) | — | Limited Availability | No longer manufactured, some supplies still available in supply chain. Distributed by Woodward Pharma Services LLC (248) 308-1120 Ext 2 | Other |
| Current | Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 81665-104-96) | — | Available | Distributed by Omnivium Pharmaceuticals LLC (888) 807-9195 | — |
Manufacturer: Micro Labs LTD 📞 (908) 484-7410 1 NDC click to expand
| Status | NDC / product | Strength | Availability | Related information | Reason |
|---|---|---|---|---|---|
| Current | Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 42571-132-52) | — | Available | — | — |
Manufacturer: Mylan Specialty, a Viatris Company 📞 (800) 796-9526 1 NDC click to expand
| Status | NDC / product | Strength | Availability | Related information | Reason |
|---|---|---|---|---|---|
| Current | Gastrocrom, Concentrate, 20 mg/1 mL (NDC 0037-0678-96) | — | Available | — | — |
Manufacturer: Rising Pharma Holdings, Inc. 📞 (201) 961-9000 or [email protected] 1 NDC click to expand
| Status | NDC / product | Strength | Availability | Related information | Reason |
|---|---|---|---|---|---|
| Current | Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 16571-600-96) | — | Available | — | — |
These rows are manufacturer reports to the FDA for Cromolyn Sodium Concentrate — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Cromolyn Sodium Concentrate? options further down this page.
Why is Cromolyn Sodium Concentrate in shortage?
For Cromolyn Sodium Concentrate, the shortage situation really comes down to one specific manufacturer — Ailex Pharmaceuticals. They make a couple of versions of the 100 mg/5 mL concentrate, and two of those specific products (distributed by Woodward Pharma Services and Ritedose Pharmaceuticals) are no longer being manufactured. There are still some remaining supplies of those two products moving through the distribution chain, but once that stock runs out, those particular versions won't be replenished. Ailex did not share a more specific public reason for stopping production of those two products beyond a general "other" category.
The good news is that not all versions of this medicine are in short supply. Ailex's third version of the 100 mg/5 mL concentrate (distributed by Omnivium Pharmaceuticals) is still listed as available, and other manufacturers' products — including from Mylan Specialty, Micro Labs, and Rising Pharma — are also currently listed as available.
Based on the manufacturer-reported reason(s) and notes on file with the FDA for Cromolyn Sodium Concentrate, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.
What should I do if I take Cromolyn Sodium Concentrate?
Cromolyn Sodium Concentrate is on the FDA's current drug-shortage list, but supply remains broadly in place. I want to point out up front that both strengths still have an available source, so the one you take should be findable.
Here is how the strengths break down: both 20 mg/1 mL and 100 mg/5 mL currently have an available source — no strength is completely without supply right now. All four manufacturers on this record are still reporting available product, and none of the listed items is marked unavailable. A few 100 mg/5 mL versions are "no longer manufactured," with some stock still moving through the supply chain, while other sources of that strength remain active. The reported reason is listed only as "Other," and this situation has lasted over a year without eliminating supply.
What you can do:
- Do not stop, skip, or change your dose on your own.
- Ask your pharmacy to order your strength — pharmacies can check wholesalers and other manufacturers, since several makers still report supply.
- If your pharmacy has trouble locating it, ask your prescriber or pharmacist about options, such as using a different strength to make up your dose.
- Manufacturer contact numbers are listed on this page for reference; your pharmacy usually handles those calls.
This is general, national information and may not match your local pharmacy's actual stock.
- Don’t stop or change the medication on your own — talk to your prescriber first.
- If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
- Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
- Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Where else can I get Cromolyn Sodium Concentrate?
FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Cromolyn Sodium Concentrate is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.
Alternative dosage forms of Cromolyn Sodium
A different form of the same drug (for example a solution when capsules are short). A form change is a clinical decision — ask your prescriber:
Therapeutic equivalents & pricing 7 productsclick to expand
Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.
| Product | Manufacturer | Package | NADAC $/unit | AB rating | Availability |
|---|---|---|---|---|---|
| cromolyn sodium 100 mg/5mL | Mylan | 12 pouches | $0.331 | AA | Discontinued |
| Cromolyn Sodium 100 mg/5mL | Rising | 12 pouches | $0.349 | AA | Availability likely |
| Cromolyn Sodium 100 mg/5mL | Micro | 8 ampules | $0.349 | AA | Availability likely |
| Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5mL | Ritedose | 12 pouches | $0.349 | AA | Discontinued |
| Cromolyn Sodium 100 mg/5mL | Omnivium | 12 pouches | $0.349 | AA | Availability likely |
| Cromolyn Sodium 100 mg/5mL | Woodward | 12 pouches | $0.483 | AA | Discontinued |
| Gastrocrom 20 mg/mL | Viatris | 12 pouches | $2.432 | AA | Availability likely |
Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.
Identity & classification
Where does this data come from?
Other pulmonary/allergy shortages
Cromolyn Sodium Concentrate shortage FAQs
Is Cromolyn Sodium Concentrate in shortage?
Why is Cromolyn Sodium Concentrate in shortage?
Which products are affected?
When will Cromolyn Sodium Concentrate be available again?
Can I still get Cromolyn Sodium somewhere?
What should I do if I take Cromolyn Sodium Concentrate?
Still have a question about the Cromolyn Sodium Concentrate shortage?
Ask a pharmacist about this shortage →View Cromolyn Sodium Concentrate on the FDA drug-shortage database →
Where does this data come from?
/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.