FDA-filed SPL labeling · retrieved through openFDA

Cromolyn Sodium Nasal Solution

Cromolyn sodium nasal solution is an allergy medication used to prevent and relieve nasal allergy symptoms such as runny nose, sneezing, itching, and nasal congestion caused by hay fever and other nasal allergies.

Brand names NasalCromGastrocrom
Drug classes Decreased Histamine Release
OTC Form 1 Route Nasal
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 →

At a glance
Linked label effectiveJun 1, 2021
Clinical labels in scope 2
AvailabilityOTC
Earliest approval/marketing year 1982
FDA-listed product records 5
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Cromolyn Sodium Nasal Solution at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Cromolyn sodium nasal solution is a well-established, non-drowsy allergy spray that helps prevent and relieve hay fever and other nasal allergy symptoms by stopping the allergic reaction before it starts. It works best when used consistently every day throughout your allergy exposure — and ideally started a week before exposure for best results. It's generally well tolerated, but if symptoms haven't improved in two weeks or you notice any serious reactions, check back with your doctor.

📖 Cromolyn Sodium Nasal Solution: Patient Information Guide

A plain-language walkthrough of Cromolyn Sodium Nasal Solution — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Cromolyn sodium nasal solution is used to prevent and relieve nasal allergy symptoms. It is available as a nasal spray under the brand names Cromolyn Sodium and NasalCrom.

  • Runny nose caused by allergies
  • Itchy nose caused by allergies
  • Sneezing from hay fever or other nasal allergies
  • Allergic nasal congestion (stuffy nose due to allergies)
⚙️How it works

Your immune system contains mast cells — small cells packed with chemicals like histamine that are released when you encounter something you're allergic to, like pollen or pet dander. That release is what causes your nose to run, itch, and swell. Cromolyn sodium works by stabilizing those mast cells so they don't release those irritating chemicals in the first place. It also blocks the release of another allergy chemical called SRS-A (slow-reacting substance of anaphylaxis). Because it prevents the reaction rather than reversing it, it works best when used regularly and started before exposure.

Importantly, cromolyn sodium is not an antihistamine, decongestant, or anti-inflammatory — it has none of those direct effects. Its benefit comes entirely from blocking the upstream allergic trigger.

💊How it's taken

Cromolyn sodium nasal solution is sprayed into the nostrils — one spray per nostril, three to four times a day (roughly every 4 to 6 hours), and up to six times daily if needed. Use it every day as long as you're exposed to your allergy trigger. For the best results, start using it up to one week before you expect to come into contact with what causes your allergies.

  • Adults and children 2 years and older: one spray per nostril, 3–4 times daily, up to 6 times daily
  • Children under 2: do not use unless your doctor says so
  • Young children should always be supervised by a parent or caregiver during use
  • Follow the pump instructions in your package insert
🤒Side effects — in detail

Cromolyn sodium nasal solution is generally well tolerated. The most commonly reported effects right after spraying are:

  • Brief stinging or burning sensation in the nose
  • Sneezing immediately after use

These are usually mild and short-lived. However, stop use and seek immediate medical help if you experience shortness of breath, wheezing, chest tightness, hives, or swelling of the mouth or throat — these can be signs of a serious allergic reaction.

⚠️Warnings & precautions

This spray treats allergic nasal symptoms only — do not use it for sinus infections, colds, or asthma. Before starting, check with your doctor if you have fever, discolored nasal discharge, sinus pain, or wheezing, since these can signal an infection or condition that needs different treatment.

  • It may take several days to feel an effect; full benefit may take 1 to 2 weeks of consistent use
  • Do not share the bottle — sharing can spread germs
  • Stop use and contact a doctor if symptoms worsen, new symptoms appear, or there's no improvement after 2 weeks
  • Talk to your doctor if you need to use it for more than 12 weeks
  • If swallowed, contact Poison Control at 1-800-222-1222 right away
  • Keep out of reach of children
🔀What it interacts with

The label does not list specific drug interactions for cromolyn sodium nasal solution. However, the directions do note that it can be used alongside other allergy medicines if desired — always let your pharmacist or doctor know everything you're taking to check for any concerns specific to your situation.

  • May be used with other allergy medicines as directed

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use if you are allergic to any ingredient in the product
  • Ask a doctor before use if you have fever, discolored nasal discharge, sinus pain, or wheezing
  • Do not use in children under 2 years old without a doctor's direction
  • Children must be supervised by a parent or caregiver during use
  • If you are pregnant or breastfeeding, ask a health professional before using
  • Do not use to treat sinus infections, asthma, or cold symptoms
🚑If you take too much

If this product is swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

📡Pharmacodynamics — effects in the body

Cromolyn sodium prevents mast cells in the nasal lining from releasing histamine and SRS-A (slow-reacting substance of anaphylaxis) — the chemicals responsible for classic allergy symptoms like itching, sneezing, and nasal congestion. It does not have any direct antihistamine, decongestant, or anti-inflammatory activity of its own. Its effect is entirely preventive: it keeps the allergic response from being triggered in the first place, which is why consistent, regular use before and during allergen exposure is key.

🔬Pharmacokinetics — how your body processes it

Cromolyn sodium is poorly absorbed into the body when used as a nasal spray — very little of the dose enters the bloodstream. Animal and volunteer studies with related cromolyn formulations confirm that systemic absorption is minimal (less than 0.07% in some models). Because so little is absorbed, it acts locally in the nasal passages rather than throughout the body, which also contributes to its favorable safety profile.

📄 Written from Cromolyn Sodium Nasal Solution’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

17

Supplements & herbs that interact with Cromolyn Sodium Nasal Solution

17 supplements and herbal products have documented interactions with Cromolyn Sodium Nasal Solution in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 9
Every supplement checked against Cromolyn Sodium Nasal Solution — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Cromolyn Sodium Nasal Solution against your exact supplements

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.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Cromolyn Sodium Nasal Solution — the kind of thing our pharmacy team would talk through with you at the counter.

How long does it take for this spray to actually start working?
It's not instant — that's one of the most important things to know about this spray. You might start to notice some improvement after a few days of regular use, but your full benefit may not kick in for 1 to 2 weeks. The key is using it every single day, even when you feel okay. Think of it more like a prevention tool than a quick-fix rescue spray.
Can I use this spray with my other allergy medicines?
Yes, you can use it alongside other allergy medicines if you need to. In fact, starting the cromolyn spray before allergy season hits — ideally up to a week before exposure — and continuing your other medicines is a reasonable approach. Just let your pharmacist know everything you're taking so they can flag anything worth watching.
I sneezed and felt a little sting right after I used it — is that normal?
Yes, that's actually a pretty common experience and nothing to worry about. A brief stinging sensation or a sneeze right after spraying is noted as a known effect of the spray. It usually passes quickly. If you have more severe reactions — like trouble breathing, hives, or swelling around your mouth or throat — that's different, and you should stop using it and get medical help right away.
My nose feels stuffy and I have some yellow discharge — can I use this spray for that?
In that case, hold off and check with your doctor first. Yellow or discolored discharge and sinus pain can be signs of a sinus infection, and this spray isn't designed to treat infections — it only addresses allergic symptoms. Using it when you have an infection won't help, and your doctor may need to treat the infection separately.
Is it safe to use this spray if I'm pregnant or breastfeeding?
The label says to ask a health professional before using it if you're pregnant or breastfeeding. That's the safest step — your doctor or midwife can weigh the benefits and any possible concerns specific to your situation and recommend the best course of action for you.
Can my child use this spray?
Children 2 years and older can use it, but a parent or caregiver should always supervise them during use. For children under 2, don't use this spray unless your doctor specifically tells you to. And one practical tip — don't share the bottle with anyone else in the family, since sharing can spread germs.
Is Cromolyn Sodium Nasal Solution available over the counter?
Yes — Cromolyn Sodium Nasal Solution is available over the counter (without a prescription) in at least some forms, according to its FDA labeling. Follow the package directions and ask your pharmacist if you're unsure which product is right for you.
When was Cromolyn Sodium Nasal Solution first available?
Cromolyn Sodium Nasal Solution has been available in the United States since at least 1982, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Cromolyn Sodium Nasal Solution?
Cromolyn Sodium Nasal Solution is supplied by 2 manufacturers listed in the FDA NDC Directory, including Prestige Brands Holdings, Inc., Bausch & Lomb Incorporated.

💬 Answers drafted from Cromolyn Sodium Nasal Solution’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Cromolyn Sodium Nasal Solution comes

Cromolyn Sodium Nasal Solution is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Nasal spray

In the nose
Brands NasalCrom
How this form is used
What it may be used for
  • Used to prevent and relieve runny or itchy nose, sneezing, and allergic nasal congestion caused by hay fever and other nasal allergies
  • Use every day while in contact with your allergy triggers such as pollen, molds, pets, or dust
  • Can be started up to one week before expected allergy exposure to help prevent symptoms
Important instructions
  • Spray once into each nostril; repeat 3 to 4 times a day (every 4 to 6 hours), and up to 6 times daily if needed
  • Adults and children 2 years and older may use; children under 2 should not use unless directed by a doctor
  • A parent or caregiver must supervise use by young children
  • Do not share the bottle with others — this can spread germs
Available strengths 2 strengths
5 FDA-listed product records

📊 Cromolyn Sodium Nasal Solution across the U.S. market

How Cromolyn Sodium Nasal Solution 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.

1
Dose forms
2
Manufacturers
2
Brand names
5
FDA-listed product records
1982
First marketed
Prestige Brands Holdings, Inc.60%
Bausch & Lomb Incorporated40%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Cromolyn Sodium Nasal Solution is used

A general measure of how commonly Cromolyn Sodium Nasal Solution 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 Sodium Nasal Solution 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.

4,088
Medicaid prescriptions filled (Q1–Q4 2025)
$46,477 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cromolyn Sodium Nasal Solution prescribed? Of the 1,596 medications we measure, Cromolyn Sodium Nasal Solution ranks #1,078 by Medicaid prescriptions — more than 32% of them.

Where Cromolyn Sodium Nasal Solution ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Cromolyn Sodium Nasal Solution 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 5.2 MG/ACTUAT Metered Dose Nasal Spray

4,088 Medicaid prescriptions (Q1–Q4 2025) 100% of Cromolyn Sodium Nasal Solution prescriptions shown $46,477 gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1797851

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 Sodium Nasal Solution, 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 1 of 7 listed Cromolyn Sodium Nasal Solution NDCs with Medicaid activity.

🔍 Compare Cromolyn Sodium Nasal Solution products

A representative set of FDA-listed product records for Cromolyn Sodium Nasal Solution — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Nasal spray
5.2 mg Nasal Bausch & Lomb Incorporated ANDA View NDC →
5.2 mg/mL Nasal Bausch & Lomb Incorporated ANDA View NDC →
5.2 mg Nasal Prestige Brands Holdings, Inc. × 3 listings ANDA View NDC →

Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Cromolyn Sodium Nasal Solution NDCs →

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.

Ingredient (IN) Cromolyn Sodium Nasal Solution RxCUI 42612 8 dose forms · 8 strengths
  1. Dose form (SCDF) Inhalation Powder RxCUI 2108327 No current FDA listing
    Clinical drug / strength (SCD) sodium 20 MG RxCUI 309548
  2. Dose form (SCDF) Inhalation Solution RxCUI 2108316 No current FDA listing
    Clinical drug / strength (SCD) sodium 10 MG/ML RxCUI 831246
  3. Dose form (SCDF) Metered Dose Inhaler RxCUI 746181 No current FDA listing
  4. Dose form (SCDF) Metered Dose Nasal Spray RxCUI 1797850 In current FDA listings
    Clinical drug / strength (SCD) sodium 5.2 MG/ACTUAT RxCUI 1797851
  5. Dose form (SCDF) Nasal Spray RxCUI 378374 In current FDA listings
    Clinical drug / strength (SCD) sodium 5.2 MG/ACTUAT RxCUI 849548
  6. Dose form (SCDF) Ophthalmic Solution RxCUI 378379 No current FDA listing
    Clinical drug / strength (SCD) sodium 20 MG/ML RxCUI 562108 sodium 40 MG/ML RxCUI 831109
  7. Dose form (SCDF) Oral Capsule RxCUI 378381 No current FDA listing
    Clinical drug / strength (SCD) sodium 100 MG RxCUI 831263
  8. Dose form (SCDF) Oral Solution RxCUI 378378 No current FDA listing
    Clinical drug / strength (SCD) sodium 20 MG/ML RxCUI 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.

🏷️ Sold under these brand names

NasalCrom Gastrocrom

🏭 Manufacturers & labelers

Prestige Brands Holdings, Inc. 3 Bausch & Lomb Incorporated 2

RxNorm drug class

Cromolyn Sodium Nasal Solution belongs to the Mast Cell Stabilizer class.

Pharmacologic class Mast Cell Stabilizer
Drug family (ATC) Antiallergic agents, excl. corticosteroids, Agents for dermatitis, excluding corticosteroids, Antiallergic agents, excl. corticosteroids

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.

🔬 Where this comes from

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 1, 2021
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cromolyn Sodium Nasal Solution.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Cromolyn Sodium Nasal Solution after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
5
Distinct labelers/manufacturers represented
2
Linked representative label
Bausch & Lomb Incorporated
Linked label effective
Jun 1, 2021
Composite sections available
7
Linked SPL Set ID
379f4b59-6866-4b5c-9b1b-d8a35b741461
Linked SPL Document ID
d66445c2-3e1d-458a-9c62-d4fc2ef4ec8f
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Bausch & Lomb Incorporated is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.