Therapeutic class — broad (HIC1)Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 codeQ7
Therapeutic class — intermediate (HIC2)Nasal Preparations
HIC3 codeQ7H
Therapeutic class — specific (HIC3)Nasal Mast Cell Stabilizers
AHFS code48:10.32.00
AHFS classMast-Cell Stabilizers
FDB label nameCROMOLYN SODIUM NASAL SPRAY
FDB brand nameCromolyn Sodium
Legend statusO — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 57782-397-26 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 57782-0397-26. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️RxNorm drug class
This medicine belongs to the Mast Cell Stabilizer class.
Pharmacologic classMast Cell Stabilizer
Drug family (ATC)Antiallergic agents, excl. corticosteroids, Agents for dermatitis, excluding corticosteroids, Antiallergic agents, excl. corticosteroids
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB PHARMACEUTICALS INC
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name CROMOLYN SODIUM NASAL SPRAYIngredient Cromolyn Sodium
📖 What it is MedlinePlus · NLM
Cromolyn is used to prevent and treat stuffy nose, sneezing, runny nose, and other symptoms caused by allergies. It works by preventing the release of substances that cause inflammation (swelling) in the air passages of the nose. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
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 benef...
How long does it take for this spray to actually start working?
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 c...
Can I use this spray with my other allergy medicines?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about Cromolyn Sodium?
Ask a licensed pharmacist directly — free, answered by our team.
Inactive ingredients, also called excipients, are components of the drug product
other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors,
or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesbenzalkonium chloride, edetate disodium, purified water
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
Price system
Per mL
Per package
Retail pharmacies payNADAC · weekly
$0.259
—
Medicaid paysCMS SDUD · 12 mo
$0.4308
—
Medicare drug plans payPart D · quarterly
No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
▼ Down 2% over the last 4 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2001
On the market since
Jul 2001
📍
2026
Currently FDA-listed
25 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 57782-0397-26, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
4.1K
Units reimbursed last 4 qtrs
107.9K
Gross reimbursed last 4 qtrs
$46.5K
Avg / prescription
$11.37
Avg / unit
$0.4308
Latest quarter Q4 2025
0Rx
Medicaid pays / mL
$0.4308
gross reimbursed
vs
NADAC / mL
$0.2588
acquisition cost
=
Spread
+$0.1720
+66% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
26% FFS74% MCO
Fee-for-service · 1,044 Rx Managed care · 3,044 Rx
State Medicaid map
Units reimbursed · per 100k residents
5.8209
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1Maine209 /100k
2Hawaii127 /100k
3Pennsylvania126 /100k
4Rhode Island116 /100k
5New York106 /100k
6Connecticut83.4 /100k
7Arizona73.1 /100k
8New Jersey72.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Cromolyn Sodium — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cromolyn Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.73M
Claims incl. refills
26.3K
Beneficiaries
18.7K
Spend / beneficiary
$199.42
Spend / claim
$142.02
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Cromolyn sodium — the ingredient across all brands.
Top reported reactions
Treatment Failure1,005
Fatigue226
Nausea197
Headache189
Diarrhoea163
Dyspnoea158
Urticaria146
Age at onset
Neonate1
Infant2
Child26
Adolescent24
Adult429
Elderly127
Reporter sex
Male · 27%
Female · 73%
Unknown · 0%
Serious outcomes
Hospitalization433
Disabling69
Life-threatening62
Death48
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
Package NDC
Description
Marketing start
Status
57782-0397-26 You're viewing this
1 BOTTLE in 1 CARTON (57782-397-26) / 200 SPRAY, METERED in 1 BOTTLE
2001-07-03
Active
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
Uses to prevent and relieve nasal symptoms of hay fever and other nasal allergies: • runny/itchy nose • sneezing • allergic stuffy nose
⏱️Dosage and Administration130 words▾
Directions • see package insert on how to use pump • parent or care provider must supervise the use of this product by young children • adults and children 2 years and older: • spray once into each nostril. Repeat 3-4 times a day (every 4-6 hours). If needed, may be used up to 6 times a day. • use every day while in contact with the cause of your allergies (pollen, molds, pets, and dust) • to prevent nasal allergy symptoms, use before contact with the cause of your allergies.
For best results, start using up to one week before contact. • if desired, you can use this product with other medicines, including other allergy medicines. • children under 2 years: Do not use unless directed by a doctor.
⚠️Warnings189 words▾
Warnings For external use only Do not use • if you are allergic to any of the ingredients Ask a doctor before use if you have • fever • discolored nasal discharge • sinus pain • wheezing When using this product • it may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks. • brief stinging or sneezing may occur right after use • do not use it to treat sinus infection, asthma, or cold symptoms • do not share this bottle with anyone else as this may spread germs Stop use and ask a doctor if • shortness of breath, wheezing, or chest tightness occurs • hives or swelling of the mouth or throat occurs • your symptoms worsen • you have new symptoms • your symptoms do not begin to improve within two weeks • you need to use for more than 12 weeks If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
🧪Active Ingredient8 words▾
Active ingredient (per spray) Cromolyn sodium 5.2 mg
🧪Inactive Ingredients8 words▾
Inactive ingredients benzalkonium chloride, edetate disodium, purified water
🎯Purpose5 words▾
Purpose Nasal allergy symptom controller
No label section mentions that — try another word, or open the full label on DailyMed below.
Glossary — plain-language definitions of medical terms used in this label:
Active ingredient: The part of a medicine that produces its intended effect on the body.
package insert: The detailed printed information about a medicine, written for health professionals, that comes with the product.
wheezing: A high-pitched whistling sound made while breathing, usually when the airways are narrowed.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.
