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Cromolyn Sodium 5.2 mg Spray, Metered — NDC 57782-0397-26 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cromolyn Sodium 5.2 mg Spray, Metered — NDC 57782-397-26 (Billing 57782-0397-26)

by Bausch & Lomb Incorporated · 1 BOTTLE in 1 CARTON / 200 SPRAY, METERED in 1 BOTTLE

This is a package of Cromolyn Sodium 5.2 mg Spray, Metered from Bausch & Lomb Incorporated, marketed since Jul 2001 and currently FDA-listed; retail pharmacies pay about $0.2588 per mL (NADAC). It is this product's only package size.

NDC 57782-0397-26
🏷️ FDA NDC (as labeled) 57782-397-26 billing pads the product segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 57782-397-26 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
57782 labeler · 397 product · 26 package
Package marketed since
Jul 3, 2001
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5778239726 3
Medicaid fills, this package
4,094 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57782-397-26
Product NDC 57782-397
11-digit billing NDC 57782039726
NCPDP billing unit ML — per mL (volume)
RxCUI 1797851
UNII Q2WXR1I0PK
Application # ANDA075702
SPL Set ID 379f4b59-6866-4b5c-9b1b-d8a35b741461
Established class (EPC) Mast Cell Stabilizer
Physiologic effect Decreased Histamine Release
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2001-07-03
Route NASAL
Dosage form SPRAY, METERED
Substance CROMOLYN SODIUM

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 42405030103410
GPI class Cromolyn Sodium
GCN Seq No 011689
GCN 46790
HICL code 004526
Ingredient (HICL) Cromolyn Sodium
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q7
Therapeutic class — intermediate (HIC2) Nasal Preparations
HIC3 code Q7H
Therapeutic class — specific (HIC3) Nasal Mast Cell Stabilizers
AHFS code 48:10.32.00
AHFS class Mast-Cell Stabilizers
FDB label name CROMOLYN SODIUM NASAL SPRAY
FDB brand name Cromolyn Sodium
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 011689
  • GCN: 46790
  • GPI-14 (Medi-Span): 42405030103410
  • HICL (First Databank): 004526
  • AHFS class code: 48:10.32.00
  • RxCUI (RxNorm): 1797851
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 class Mast 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.

Clinical

Label name CROMOLYN SODIUM NASAL SPRAY Ingredient 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.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps prevent and relieve nasal symptoms of hay fever and other nasal allergies. That means a runny or itchy nose, sneezing and an allergic stuffy nose.
  • It may take several days to notice a difference. Your best effect may not show up for 1 to 2 weeks. If you have not improved after two weeks, check in with your doctor.
  • Adults and children 2 and older generally spray once in each nostril, 3 to 4 times a day. Use it daily while you are around your triggers. To prevent symptoms, start up to a week b...
  • Some people have brief stinging or sneezing right after a spray. That is usually short-lived. Stop and get help if you have wheezing, chest tightness, hives, or swelling of the mou...
📖 Read our full Cromolyn Sodium Nasal Solution guide →
Where does this data come from?
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.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.259 —
Medicaid paysCMS SDUD · 12 mo $0.4310 —
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
Nov 2022 Nov 2023 Jan 2024 Feb 2024 $0.264 $0.256
▼ 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
57782-0397-26 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 200 SPRAY, METERED in 1 BOTTLE 2001-07-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cromolyn Sodium 5.2 mgthis 57782-0397-26 Bausch 1 bottle $0.259 — FDA listed —
NasalCrom 5.2 mg 52183-0199-13 Prestige 1 bottle — — FDA listed —
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.

Inactive Ingredients / Excipients

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.

🧪 Avoiding an ingredient? See Cromolyn Sodium Nasal Solution inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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.

Manufacturer & labeler

LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB PHARMACEUTICALS INC
FDA applicationANDA075702 (ANDA)
Labeler code57782
First marketedJul 2001
Product typeHuman Otc Drug
Portfolio92 products on file
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.

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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

Uses to prevent and relieve nasal symptoms of hay fever and other nasal allergies: • runny/itchy nose • sneezing • allergic stuffy nose

⏱️ Dosage and Administration 130 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.

⚠️ Warnings 189 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 Ingredient 8 words ▾

Active ingredient (per spray) Cromolyn sodium 5.2 mg

🧪 Inactive Ingredients 8 words ▾

Inactive ingredients benzalkonium chloride, edetate disodium, purified water

🎯 Purpose 5 words ▾

Purpose Nasal allergy symptom controller

📄 Do Not Use 13 words ▾

Do not use • if you are allergic to any of the ingredients

📄 Ask a Doctor Before Use If 19 words ▾

Ask a doctor before use if you have • fever • discolored nasal discharge • sinus pain • wheezing

📄 When Using This Product 65 words ▾

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 56 words ▾

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 11 words ▾

If pregnant or breast feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 6 words ▾

Questions or comments? Call toll-free 1-800-323-0000

📄 Package Label / Principal Display Panel 60 words ▾

Package/Label Principal Display Panel HealthGuard NDC 57782-397-26 Cromolyn Sodium Nasal Solution, USP NASAL SPRAY Nasal Allergy Symptom Controller For intranasal use only. Prevents and Relieves Nasal Allergy Symptoms: • runny/itchy nose • sneezing • allergic stuffy nose Original Prescription Strength Safe For Ages 2+ 200 Metered Sprays Each spray delivers 5.2 mg cromolyn sodium

0.88 FL OZ (26 mL) carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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
108.1K
Gross reimbursed last 4 qtrs
$46.6K
Avg / prescription
$11.38
Avg / unit
$0.4310
Latest quarter Q4 2025
0Rx
Medicaid pays / mL
$0.4310
gross reimbursed
vs
NADAC / mL
$0.2588
acquisition cost
=
Spread
+$0.1722
+67% 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% FFS 74% MCO
Fee-for-service · 1,044 Rx Managed care · 3,050 Rx
State Medicaid map
Alaska: no data reported AK Maine: 2,912 units · 209 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 4,082 units · 71.2 per 100k residents MN Wisconsin: no data reported WI Michigan: 6,344 units · 63.2 per 100k residents MI New York: 20,800 units · 106 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 2,678 units · 63.3 per 100k residents OR Nevada: 1,898 units · 59.4 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 4,680 units · 37.3 per 100k residents IL Indiana: no data reported IN Ohio: 7,085 units · 60.1 per 100k residents OH Pennsylvania: 16,363 units · 126 per 100k residents PA New Jersey: 6,770 units · 72.9 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 2,990 units · 66.1 per 100k residents KY West Virginia: no data reported WV Virginia: 2,444 units · 28.0 per 100k residents VA Maryland: 3,848 units · 62.3 per 100k residents MD Connecticut: 3,016 units · 83.4 per 100k residents CT Rhode Island: 1,274 units · 116 per 100k residents RI Arizona: 5,434 units · 73.1 per 100k residents AZ New Mexico: 442 units · 20.9 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 312 units · 5.8 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 6,942 units · 62.9 per 100k residents GA D.C.: no data reported DC Hawaii: 1,820 units · 127 per 100k residents HI Texas: 5,512 units · 18.1 per 100k residents TX Florida: no data reported FL
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
🏆 Top states by units · per 100k residents
1 Maine 209 /100k
2 Hawaii 127 /100k
3 Pennsylvania 126 /100k
4 Rhode Island 116 /100k
5 New York 106 /100k
6 Connecticut 83.4 /100k
7 Arizona 73.1 /100k
8 New Jersey 72.9 /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.
← 57755-0004-01 · Guilin 57799-0001-01 · Allegheny →
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.