Cromolyn Oral Inhalation
Cromolyn oral inhalation is a preventive (prophylactic) medication used to manage bronchial asthma and to help prevent exercise- or exposure-triggered airway tightening.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Cromolyn is an older preventive asthma medicine, a mast cell stabilizer that stops certain immune cells from releasing histamine and other chemicals that swell and tighten the airways. It has been on the U.S. market since about 1993, is available generically, and is now usually a second choice behind inhaled steroids. It is one of the gentlest asthma medicines, and the side effects people notice are usually a mild cough or a stuffy nose after a treatment. It will not stop an attack already underway, so keep your rescue inhaler handy, and expect several weeks of steady daily use before it shows its full effect.
Clinical pearls
- Swallowing the solution does nothing, because cromolyn only works when breathed in as a mist through the nebulizer.
- For exercise, cold dry air or animal dander, a dose taken shortly before exposure can help prevent airway tightening.
- Never lower your steroid on your own, and once it is lowered, stopping cromolyn suddenly can trigger a severe flare.
- New or worsening wheezing right after a treatment means the drug may be irritating your airways, so call your doctor.
Patient information guide A plain-language walkthrough of Cromolyn Oral Inhalation, written from its FDA label.
What Cromolyn Oral Inhalation is used for
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Cromolyn sodium oral inhalation is used as a preventive treatment — not a rescue medicine — for airway conditions triggered by asthma and environmental exposures.
- Management of bronchial asthma in adults and children (two years and older) who need daily, ongoing medication to control symptoms
- Prevention of acute bronchospasm (sudden airway tightening) triggered by exercise, cold dry air, animal dander, toluene diisocyanate, or environmental pollutants — taken as a single dose shortly before exposure
How Cromolyn Oral Inhalation works
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Cromolyn sodium works by preventing mast cells — immune cells found in the airways — from releasing irritating chemicals like histamine and SRS-A (a substance that causes airway swelling). When you breathe in an allergen or trigger, mast cells normally burst open (degranulate) and flood the airway with these chemicals, causing tightening and inflammation. Cromolyn sodium blocks that process before it starts. It has no antihistamine or anti-inflammatory effect on its own — it simply stops the trigger from setting off the chain reaction in the first place.
Cromolyn Oral Inhalation dosage
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For ongoing asthma management, cromolyn sodium inhalation solution is typically inhaled via nebulizer four times a day at regular intervals. For preventing a reaction to a known trigger (like exercise or allergen exposure), one dose is inhaled shortly before the exposure. The medicine must be inhaled — swallowing it does not work.
- Start cromolyn sodium only after an acute asthma episode is under control and your airway is clear enough to inhale properly
- If your asthma improves over time, your doctor may gradually reduce the frequency — do not reduce it on your own
- Take doses at regular times; consistent use is what makes this medicine effective
Dosing details from the FDA-approved label
From the Cromolyn Oral Inhalation prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Management of bronchial asthma in adults and pediatric patients (two years of age and over)
- The usual starting dosage is the contents of one ampule administered by nebulization four times a day at regular intervals
- If asthma is under good control, dosage may be titrated downward to the lowest level consistent with the desired effect; the usual decrease is from four to three ampules per day
- Prevention of acute bronchospasm following exercise or exposure to cold dry air, environmental agents (e.g., animal danders, toluene diisocyanate, pollutants), etc.
- The usual dose is the contents of one ampule administered by nebulization shortly before exposure to the precipitating factor
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION For management of bronchial asthma in adults and pediatric patients (two years of age and over), the usual starting dosage is the contents of one ampule administered by nebulization four times a day at regular intervals. Drug stability and safety of cromolyn sodium inhalation solution when mixed with other drugs in a nebulizer have not been established. Patients with chronic asthma should be advised that the effect of cromolyn sodium inhalation solution therapy is dependent upon its administration at regular intervals, as directed. Cromolyn sodium inhalation solution should be introduced into the patient's therapeutic regimen when the acute episode has been controlled, the airway has been cleared and the patient is able to inhale adequately. For the prevention of acute bronchospasm which follows exercise or exposure to cold dry air, environmental agents ( e.g. , animal danders, toluene diisocyanate, pollutants), etc., the usual dose is the contents of one ampule administered by nebulization shortly before exposure to the precipitating factor. It should be emphasized to the patient that the drug is poorly absorbed when swallowed and is not effective by this route of administration. For additional information, see the accompanying leaflet entitled “ Living a Full Life with Asthma” . Cromolyn sodium inhalation solution Therapy in Relation to Other Treatments for Asthma: Non-steroidal agents Cromolyn sodium inhalation solution should be added to the patient's existing treatment regimen ( e.g. , bronchodilators). When a clinical response to cromolyn sodium inhalation solution is evident, usually within two to four weeks, and if the asthma is under good control, an attempt may be made to decrease concomitant medication usage gradually. If concomitant medications are eliminated or required on no more than a prn basis, the frequency of administration of cromolyn sodium inhalation solution may be titrated downward to the lowest level consistent with the desired effect. The usual decrease is from four to three ampules per day. It is important that the dosage be reduced gradually to avoid exacerbation of asthma.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Cromolyn Oral Inhalation side effects
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Most people tolerate cromolyn sodium well — side effects are generally uncommon. The most frequently reported ones include:
Common side effects
- Cough
- Wheezing
- Nasal congestion
- Sneezing
- Nausea
- Drowsiness
- Stomachache
When to get medical help
- Get emergency help right away if you develop signs of a severe allergic reaction (anaphylaxis): sudden difficulty breathing, throat swelling, hives, or feeling faint.
- Call your doctor if you develop new or worsening wheezing or bronchospasm (airway tightening) after using this medication.
- Call your doctor if you notice swelling of the face, lips, tongue, or throat (angioedema).
- Do not use this medicine during a severe, active asthma attack (status asthmaticus) — it will not help and other treatment is needed immediately.
Rarely, serious reactions can occur — including severe allergic reactions (anaphylaxis), throat or face swelling (angioedema), bronchospasm, or joint swelling and pain. Seek emergency help or call your doctor right away if any of these develop.
Cromolyn Oral Inhalation warnings and precautions
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- Not for active asthma attacks: Cromolyn sodium has no role in treating a severe, ongoing asthma attack (status asthmaticus). Always have a rescue inhaler on hand.
- Rare but serious allergic reactions: Anaphylaxis has been reported. Signs include sudden breathing difficulty, throat swelling, and hives — call 911 immediately if this happens.
- Do not stop suddenly if you've reduced corticosteroids: If cromolyn sodium has allowed you to lower your steroid dose, stopping cromolyn abruptly can trigger a severe asthma flare. Your doctor must supervise any changes.
- Corticosteroid tapering requires close supervision: Long-term steroid use affects your adrenal glands (the glands that help your body handle stress). Even after steroids are stopped, your body may need them again during serious illness, surgery, or a bad asthma attack — for up to two years after stopping.
Cromolyn Oral Inhalation interactions
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There are limited drug interactions described in the label, but one important one to know:
- Isoproterenol during pregnancy: Animal studies found that combining cromolyn sodium with isoproterenol (a bronchodilator) during pregnancy increased the risk of fetal harm. If you are pregnant and using isoproterenol, talk to your doctor before taking cromolyn sodium.
Interactions listed in the FDA-approved label
From the Cromolyn Oral Inhalation prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Isoproterenol: In pregnant mice given subcutaneous injections, adding cromolyn sodium (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m2 basis) to isoproterenol (approximately 7 times that dose) appears to have increased the incidence of both resorptions and malformations.
Read the label’s full interactions text
Drug Interaction During Pregnancy Cromolyn sodium and isoproterenol were studied following subcutaneous injections in pregnant mice. Cromolyn sodium alone in doses up to 540 mg/kg (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) did not cause significant increases in resorptions or major malformations. Isoproterenol alone at a dose of 2.7 mg/kg (approximately 7 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) increased both resorptions and malformations. The addition of cromolyn sodium (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) to isoproterenol (approximately 7 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) appears to have increased the incidence of both resorptions and malformations.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Cromolyn Oral Inhalation
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- Allergy to cromolyn sodium: Do not use this medicine if you have had a hypersensitivity (allergic) reaction to it before.
- Active asthma attack: Do not start or rely on this medicine during an acute episode — wait until the attack is controlled and you can inhale adequately.
- Pregnancy: Animal data suggest a potential risk when combined with isoproterenol; discuss with your doctor if you are pregnant or planning to be.
- Children: The inhalation solution via nebulizer is approved for children two years of age and older.
- Corticosteroid users: Tell your doctor if you take steroids for asthma — any reduction must be done very slowly and under medical supervision.
- Other asthma medications: Cromolyn sodium should be added to your existing regimen; do not use it as a replacement for bronchodilators or other treatments without your doctor's guidance.
Cromolyn Oral Inhalation overdose
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There is no recognized clinical syndrome from a cromolyn sodium overdose. In animal studies, even very high doses caused toxicity only at extremely high levels far beyond any human dose, and inhalation studies in animals could not achieve toxic levels at all. If you are concerned about taking too much, contact a poison control center or your healthcare provider.
What Cromolyn Oral Inhalation does in the body
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Cromolyn sodium prevents airway mast cells from releasing histamine and other inflammatory chemicals (like SRS-A) that cause bronchospasm and swelling. It does not directly constrict or dilate blood vessels, block histamine receptors, or reduce existing inflammation — its entire effect is upstream, preventing those chemical signals from being released in the first place.
How your body processes Cromolyn Oral Inhalation
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Cromolyn sodium is poorly absorbed into the body — when inhaled, very little enters the bloodstream. The drug works locally in the airways rather than through a systemic (whole-body) effect. Because it is so poorly absorbed, swallowing the solution has no therapeutic benefit.
How to store Cromolyn Oral Inhalation
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Store at 20°C to 25°C (68°F to 77°F) . PROTECT FROM LIGHT.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Cromolyn Oral Inhalation
17 supplements and herbal products have documented interactions with Cromolyn Oral Inhalation in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Cromolyn Oral Inhalation: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Cromolyn Oral Inhalation — the kind of thing our pharmacy team would talk through with you at the counter.
Will this inhaler stop an asthma attack if I'm already having one?
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How long does it take before I notice it working?
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Can I use it before going to the gym to prevent exercise-triggered symptoms?
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I'm also on a steroid inhaler. Can I use cromolyn sodium alongside it?
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Are there any serious side effects I should watch out for?
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Is it safe to mix this solution with my other nebulizer medications?
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Is Cromolyn Oral Inhalation available over the counter?
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When was Cromolyn Oral Inhalation first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Cromolyn Oral Inhalation on HelloPharmacist
Cromolyn Oral Inhalation on the U.S. market: products, makers and brands
How Cromolyn Oral Inhalation appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
The FDA lists Cromolyn Oral Inhalation products; the earliest marketing or approval year on record is 1982. Brand names on the directory include Intal, Nasalcrom, Gastrocrom; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (18) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Cromolyn Oral Inhalation is used (Medicaid data)
A general measure of how commonly Cromolyn Oral Inhalation is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Cromolyn Oral Inhalation is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Cromolyn Oral Inhalation prescribed? Of the 1,601 medications we measure, Cromolyn Oral Inhalation ranks #1,321 by Medicaid prescriptions — more than 17% of them.
Utilization by Cromolyn Oral Inhalation product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
cromolyn sodium 10 MG/ML Inhalation Solution
Summed across the 2 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 831246
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cromolyn Oral Inhalation, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 18 listed Cromolyn Oral Inhalation NDCs with Medicaid activity.
Cromolyn Oral Inhalation side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Cromolyn Oral Inhalation — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Cromolyn Oral Inhalation in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Cromolyn Oral Inhalation FDA approval history
How Cromolyn Oral Inhalation went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Cromolyn Oral Inhalation recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Cromolyn recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For Inhalation or Injection, Must be Diluted, Manufactured by: The Ritedose Cor… Lots: Lot: 23CE2, Exp. 03/31/2026 FDA record D-0946-2023 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 42612 8 dose forms · 8 strengths
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Dose form (SCDF) Inhalation Powder RxCUI 2108327No current FDA listingClinical drug / strength (SCD) sodium 20 MGRxCUI 309548 -
Dose form (SCDF) Inhalation Solution RxCUI 2108316No current FDA listingClinical drug / strength (SCD) sodium 10 MG/MLRxCUI 831246 -
Dose form (SCDF) Metered Dose Inhaler RxCUI 746181No current FDA listing -
Dose form (SCDF) Metered Dose Nasal Spray RxCUI 1797850No current FDA listingClinical drug / strength (SCD) sodium 5.2 MG/ACTUATRxCUI 1797851 -
Dose form (SCDF) Nasal Spray RxCUI 378374No current FDA listingClinical drug / strength (SCD) sodium 5.2 MG/ACTUATRxCUI 849548 -
Dose form (SCDF) Ophthalmic Solution RxCUI 378379No current FDA listing -
Dose form (SCDF) Oral Capsule RxCUI 378381No current FDA listingClinical drug / strength (SCD) sodium 100 MGRxCUI 831263 -
Dose form (SCDF) Oral Solution RxCUI 378378No current FDA listingClinical drug / strength (SCD) sodium 20 MG/MLRxCUI 831261
Look up RxCUI 42612 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Cromolyn Oral Inhalation supply and shortage status
Whether Cromolyn Oral Inhalation is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Cromolyn Oral Inhalation brand names
Cromolyn Oral Inhalation is sold under 3 brand names in the FDA directory — Intal, Nasalcrom, Gastrocrom. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Cromolyn Oral Inhalation drug class (RxNorm)
Cromolyn Oral Inhalation belongs to the Mast Cell Stabilizer class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Cromolyn Oral Inhalation page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Micro Labs Limited is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →