Cromolyn Sodium 40 mg/mL Solution/ Drops, 10 mL — NDC 61314-237-10 (Billing 61314-0237-10)
This is a package of 10 mL of Cromolyn Sodium 40 mg/mL Solution/ Drops from Sandoz Inc, marketed since Jun 1999 and currently FDA-listed; retail pharmacies pay about $0.5953 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 61314-237-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 61314 labeler · 237 product · 10 package
- Package marketed since
- Jun 29, 1999
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 10 mL per package
- Barcode (UPC)
- 0361314237101
- Medicaid fills, this package
- 70,302 prescriptions in the last four reported quarters
- FDA record last changed
- Aug 13, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 044694
- GCN: 69069
- HICL (First Databank): 004526
- AHFS class code: 48:10.32.00
- RxCUI (RxNorm): 831109
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Mast Cell Stabilizer class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Cromolyn ophthalmic is used to treat the symptoms of allergic conjunctivitis (a condition in which the eyes become itchy, swollen, red, and teary when they are exposed to certain substances) and keratitis (a condition that causes swelling of the cornea [tissue in the front of the eye] that causes eye redness, pain, and tearing and changes in vision) in adults and children 4 years of age and older. Cromolyn is in a class of medications called mast cell stabilizers. It works by preventing the release of substances that cause inflammation (swelling) of the eyes.
Read the full MedlinePlus article ↗- It's actually for a specific group of recurring seasonal allergic eye conditions called vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis. 'Vernal' means the...
- What exactly is this eye drop treating — is it just regular eye allergies?
- Most people start to notice less itching, tearing, redness, and discharge within a few days of using the drops consistently. That said, for some people it can take up to six weeks...
- How long before these drops actually start helping?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Cromolyn Sodium — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.595 | $5.95 / 10 ml |
| Medicaid paysCMS SDUD · 12 mo | $2.04 | $20.35 / 10 ml |
| Medicare drug plans payPart D · Q2 2026 | $1.71 | $17.12 / 10 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 61314-0237-10 You're viewing this Main listing | 10 mL in 1 BOTTLE, PLASTIC | 1999-06-29 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cromolyn Sodium 40 mg/mLthis 61314-0237-10 | Sandoz | 10 ml | $0.595 | — | Availability likely | — |
| Cromolyn Sodium 40 mg/mL 50090-1202-00 | A-S | 10 ml | — | — | FDA listed | — |
| Cromolyn Sodium 40 mg/mL 68788-8490-01 | Preferred | 10 ml | — | — | FDA listed | — |
| Cromolyn Sodium 40 mg/mL 71205-0230-10 | Proficient | 10 ml | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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 Ophthalmic 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.
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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.
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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.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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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.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Sandoz Inc labeler code 61314
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- WYOST denosumab 120 mg/1.7mL Injection NDC 61314-228-94
- Carteolol Hydrochloride 10 mg/mL Solution NDC 61314-238-05
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- Betaxolol Hydrochloride 5.6 mg/mL Solution/ Drops NDC 61314-245-01
- Azelastine Hydrochloride .5 mg/mL Solution/ Drops NDC 61314-308-02
- ZARXIO filgrastim-sndz 300 ug/.5mL Injection, Solution NDC 61314-318-01
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The dose is 1 or 2 drops in each eye 4 to 6 times a day at regular intervals. One drop contains approximately 1.6 mg cromolyn sodium. Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed.
Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement. If required, corticosteroids may be used concomitantly with Cromolyn Sodium Ophthalmic Solution USP, 4%.
⛔ Contraindications ▾
CONTRAINDICATIONS Cromolyn Sodium Ophthalmic Solution USP, 4% is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The most frequently reported adverse reaction attributed to the use of cromolyn sodium ophthalmic solution, on the basis of reoccurrence following readministration, is transient ocular stinging or burning upon instillation. The following adverse reactions have been reported as infrequent events. It is unclear whether they are attributable to the drug: Conjunctival injection; watery eyes; itchy eyes; dryness around the eye; puffy eyes; eye irritation; and styes.
Immediate hypersensitivity reactions have been reported rarely and include dyspnea, edema and rash.
🤰 Pregnancy ▾
Pregnancy
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in children below the age of 4 years have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Cromolyn sodium acts by inhibiting the release of histamine and SRS-A (slow-reacting substance of anaphylaxis) from the mast cell. Another activity demonstrated in vitro is the capacity of cromolyn sodium to inhibit the degranulation of non-sensitized rat mast cells by phospholipase A and the subsequent release of chemical mediators.
Another study showed that cromolyn sodium did not inhibit the enzymatic activity of released phospholipase A on its specific substrate. Cromolyn sodium has no intrinsic vasoconstrictor, antihistaminic or anti-inflammatory activity. Cromolyn sodium is poorly absorbed.
When multiple doses of cromolyn sodium ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of cromolyn sodium is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the cromolyn sodium dose penetrate into the aqueous humor and clearance from this chamber is virtually complete within 24 hours after treatment is stopped. In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of cromolyn sodium is absorbed following administration to the eye.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Cromolyn Sodium Ophthalmic Solution USP, 4% is supplied in a white, opaque, plastic ophthalmic dispenser in the following size: 10 mL NDC 61314-237-10 Storage: Store between 15° to 30°C (59° to 86°F). Protect from light-store in original carton. Keep tightly closed. KEEP OUT OF THE REACH OF CHILDREN.
📋 Description ▾
DESCRIPTION Cromolyn Sodium Ophthalmic Solution USP, 4% is a clear, colorless, sterile solution intended for topical ophthalmic use. Cromolyn sodium is represented by the following structural formula: Chemical Name: Disodium 5-5'-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate] Pharmacologic Category: Mast cell stabilizer. Each mL contains: Active: cromolyn sodium 40 mg (4%); Preservative: benzalkonium chloride 0.01%.
Inactives: edetate disodium 0.1% and purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.0-7.0). chemicalstructure
💬 Information for Patients ▾
Information for the Patient Patients should be advised to follow the patient instructions listed on the Information for Patients sheet. Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of vernal keratoconjunctivitis, vernal conjunctivitis, or vernal keratitis. Do not wear contact lenses during treatment with Cromolyn Sodium Ophthalmic Solution USP, 4%.
⚠️ Precautions ▾
PRECAUTIONS General Patients may experience a transient stinging or burning sensation following application of Cromolyn Sodium Ophthalmic Solution USP, 4%. The recommended frequency of administration should not be exceeded (see DOSAGE AND ADMINISTRATION ). Information for the Patient Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.
Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of vernal keratoconjunctivitis, vernal conjunctivitis, or vernal keratitis. Do not wear contact lenses during treatment with Cromolyn Sodium Ophthalmic Solution USP, 4%. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies of cromolyn sodium in mice (12 months intraperitoneal administration at doses up to 150 mg/kg three days per week), hamsters (intraperitoneal administration at doses up to 52.6 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks), and rats (18 months subcutaneous administration at doses up to 75 mg/kg six days per week) showed no neoplastic effects.
The average daily maximum dose levels administered in these studies were 192.9 mg/m 2 for mice, 47.2 mg/m 2 for hamsters and 385.8 mg/m 2 for rats. These doses correspond to approximately 6.8, 1.7 and 14 times the maximum daily human dose of 28 mg/m 2 . Cromolyn sodium showed no mutagenic potential in the Ames Salmonella /microsome plate assays, mitotic gene conversion in Saccharomycas cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes.
No evidence of impaired fertility was shown in laboratory reproduction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day (1050 mg/m 2 ) in males and 100 mg/kg/day (600 mg/m 2 ) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m 2 . Pregnancy Teratogenic Effects Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg (1620 mg/m 2 ) and 164 mg/kg (984 mg/m 2 ), respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg (5820 mg/m 2 ) produced no evidence of fetal malformation.
These doses represent approximately 57, 35, and 205 times the maximum daily human dose, respectively, on a mg/m 2 basis. Adverse fetal effects (increased resorption and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity. There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cromolyn Sodium Ophthalmic Solution USP, 4% is administered to a nursing woman.
Pediatric Use Safety and effectiveness in children below the age of 4 years have not been established.
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cromolyn Sodium Ophthalmic Solution USP, 4% is administered to a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies of cromolyn sodium in mice (12 months intraperitoneal administration at doses up to 150 mg/kg three days per week), hamsters (intraperitoneal administration at doses up to 52.6 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks), and rats (18 months subcutaneous administration at doses up to 75 mg/kg six days per week) showed no neoplastic effects. The average daily maximum dose levels administered in these studies were 192.9 mg/m 2 for mice, 47.2 mg/m 2 for hamsters and 385.8 mg/m 2 for rats.
These doses correspond to approximately 6.8, 1.7 and 14 times the maximum daily human dose of 28 mg/m 2 . Cromolyn sodium showed no mutagenic potential in the Ames Salmonella /microsome plate assays, mitotic gene conversion in Saccharomycas cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes. No evidence of impaired fertility was shown in laboratory reproduction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day (1050 mg/m 2 ) in males and 100 mg/kg/day (600 mg/m 2 ) in females.
These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m 2 .
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 61314-237-10 Rx Only Cromolyn Sodium Ophthalmic Solution USP 4% FOR TOPICAL APPLICATION IN THE EYE STERILE 10 mL SANDOZ 10mlcarton