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Cyclomydril cyclopentolate hydrochloride and phenylephrine 2 mg/mL; 10 mg/mL Solution/ Drops, 5 mL — NDC 00065-0359-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cyclomydril cyclopentolate hydrochloride and phenylephrine 2 mg/mL; 10 mg/mL Solution/ Drops, 5 mL — NDC 0065-0359-05 (Billing 00065-0359-05)

by Alcon Laboratories, Inc. · 5 mL in 1 BOTTLE, PLASTIC

This is a package of 5 mL of Cyclomydril cyclopentolate hydrochloride and phenylephrine 2 mg/mL; 10 mg/mL Solution/ Drops from Alcon Laboratories, Inc., marketed since Jun 1958 and currently FDA-listed.

NDC 00065-0359-05
🏷️ FDA NDC (as labeled) 0065-0359-05 billing pads the labeler segment with a zero
This package
Contains5 mL Medicaid pays$13.47 / unit · 12 mo Per package$67.33 / 5 ml · Medicaid Pack sizes2 compare ↓
Product page 00065-0359-02 Also comes in: 2 ml 0065-0359-02
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0065-0359-05
Product NDC 0065-0359
11-digit billing NDC 00065035905
NCPDP billing unit ML — per mL (volume)
RxCUI 1298068, 1298360
UNII 736I6971TE, 04JA59TNSJ
UPC 0300650359054
Application # ANDA084300
SPL Set ID 8268b70f-3f10-48dd-bb24-baaeb27a1325
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1958-06-30
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

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

GPI-14 86359902102010
GPI class Cyclomydril
GCN Seq No 048541
GCN 14277
HICL code 003473
Ingredient (HICL) Cyclopentolate/Phenylephrine
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6J
Therapeutic class — specific (HIC3) Mydriatics
AHFS code 52:24.00.00
AHFS class Mydriatics
FDB label name CYCLOMYDRIL EYE DROPS
FDB brand name Cyclomydril
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 048541
  • GCN: 14277
  • GPI-14 (Medi-Span): 86359902102010
  • HICL (First Databank): 003473
  • AHFS class code: 52:24.00.00
  • RxCUI (RxNorm): 1298068
Why two NDCs? The FDA registers this code as 0065-0359-05 — a 4-4-2 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 labeler segment → 00065-0359-05. 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 Anticholinergics class.

Drug family (ATC) Anticholinergics
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 CYCLOMYDRIL EYE DROPS Ingredient Cyclopentolate/Phenylephrine

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $13.47 $67.33 / 5 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
00065-0359-02 0065-0359-02 Main listing 2 mL in 1 BOTTLE, PLASTIC 1958-06-30 — Active
00065-0359-05 You're viewing this 5 mL in 1 BOTTLE, PLASTIC 1958-06-30 — Active

You're viewing the largest of 2 pack sizes for this product.

This pack accounts for about 3.0% of this product's recent Medicaid fills; most go to the 2 ml pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 5 mL — 5 ml in 1 bottle, plastic.
How does this package differ from NDC 00065-0359-02?
Both are Cyclomydril cyclopentolate hydrochloride and phenylephrine 2 mg/mL; 10 mg/mL Solution/ Drops — the drug itself is identical. This page's package is the 5 mL one, while NDC 00065-0359-02 is the 2 ml package.
What NDC number is used to bill for this package of Cyclomydril cyclopentolate hydrochloride and phenylephrine 2 mg/mL; 10 mg/mL Solution/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cyclomydril 2 mg/mL; 10 mg/mLthis 00065-0359-05 Alcon 5 ml — — 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

🏛️
1958
On the market since
Jun 1958
📍
2026
Currently FDA-listed
68 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.

💡 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 R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • 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 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 45P3261C7T
    Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
  • 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.

6 inactive ingredients listed in the exact product block matched to this NDC.

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

LabelerAlcon Laboratories, Inc.
Application holderALCON LABORATORIES INC
FDA applicationANDA084300 (ANDA)
Labeler code00065
First marketedJun 1958
Product typeHuman Prescription Drug
Portfolio55 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

INDICATIONS AND USAGE For the production of mydriasis.

⏱️ Dosage and Administration 39 words ▾

DOSAGE AND ADMINISTRATION Instill one drop in each eye every five to ten minutes. To minimize systemic absorption, apply pressure over the nasolacrimal sac for two to three minutes following instillation. Observe infants closely for at least 30 minutes.

⛔ Contraindications 14 words ▾

CONTRAINDICATIONS Do not use in patients with hypersensitivity to any component of this preparation.

⚠️ Warnings 83 words ▾

WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using higher concentrations of phenylephrine.

These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. This preparation may cause central nervous system (CNS) disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions.

Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate.

🤒 Adverse Reactions 176 words ▾

ADVERSE REACTIONS Ocular The following ocular adverse experiences have been associated with the use of CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution): increased intraocular pressure, burning/irritation upon instillation, photophobia, blurred vision and superficial punctate keratitis. Nonocular Use of cyclopentolate hydrochloride has been associated with psychotic reactions and behavioral disturbances in children. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place.

This drug produces reactions similar to those of other adrenergic and anticholinergic drugs; however, the central nervous system manifestations as noted above are most common. Other manifestations of adrenergic and anticholinergic topical ophthalmic drugs include tachycardia, hyperpyrexia, hypertension, vasodilation, urinary retention, diminished gastrointestinal motility, convulsion, bradycardia, apnea, necrotizing colitis and abdominal distention (in newborns and especially premature infants), skin rash, drowsiness, and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages.

Severe manifestations of toxicity include coma, medullary paralysis and death. Systemic toxicity can result from topical application of sympathomimetic drugs: headache, blood pressure elevation, extrasystoles, tachycardia, syncope and cerebrovascular accidents have been reported.

🤰 Pregnancy 60 words ▾

Pregnancy Animal reproduction studies have not been conducted with cyclopentolate hydrochloride and/or phenylephrine hydrochloride. It is also not known whether cyclopentolate hydrochloride and/or phenylephrine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 86 words ▾

Pediatric Use Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place.

Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld after administration, and to observe infants closely for at least 30 minutes (see PRECAUTIONS ).

🧓 Geriatric Use 17 words ▾

Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🆘 Overdosage 70 words ▾

OVERDOSAGE Excessive dosage may produce behavioral disturbances, tachycardia, hyperpyrexia, hypertension, elevated intraocular pressure, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Pulmonary oedema or cardiac arrest may occur due to phenylephrine toxicity. Severe intoxication is characterized by central nervous system depression, coma, circulatory and respiratory failure, and death.

Patients exhibiting signs of overdosage should receive supportive care and monitoring.

🧬 Clinical Pharmacology 61 words ▾

CLINICAL PHARMACOLOGY Cyclopentolate hydrochloride is an anticholinergic drug and phenylephrine hydrochloride is an adrenergic drug. This combination induces mydriasis that is greater than that of either drug alone at its respective concentration. The concentrations of cyclopentolate hydrochloride and phenylephrine hydrochloride have been selected to induce mydriasis with little accompanying cycloplegia.

Heavily pigmented irides may require more doses than lightly pigmented irides.

📦 How Supplied / Storage and Handling 44 words ▾

HOW SUPPLIED CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is supplied as a sterile solution in 2 mL and 5 mL, in plastic DROP-TAINER® dispensers. 2 mL NDC 0065-0359-02 5 mL NDC 0065-0359-05 Storage: Store at 8°C to 25°C (46°F - 77°F)

📋 Description 122 words ▾

DESCRIPTION CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution. The active ingredients are represented by the chemical structures: Established Name: Cyclopentolate Hydrochloride Chemical Name: 2-(Dimethylamino)ethyl 1 - hydroxy-α-phenylcyclopentaneacetate hydrochloride) Molecular Formula: C 17 H 25 NO 3 • HCl Molecular Weight: 327.85 g/mol Established Name: Phenylephrine Hydrochloride Chemical Name: 3-hydroxy-α[(methylamino)-methyl]-, Benzenemethanol, hydrochloride (R)-.

Molecular Formula: C 9 H 13 NO 2 • HCl Molecular Weight: 203.67 g/mol Each mL of CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) contains: Active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium, boric acid, hydrochloric acid and /or sodium carbonate (to adjust pH), purified water. cyclopentolate hydrochloride phenylephrine hydrochloride

💬 Information for Patients 39 words ▾

Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in hazardous activities while pupils are dilated. Patient may experience sensitivity to light.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Caution should be observed when considering use of this medication in the presence of Down's syndrome due to potential increased sensitivity to anticholinergics. This product should be used with caution in patients at risk for angle closure due to the potential to precipitate acute angle closure. Because of the risk of provoking hyperthermia, use with caution in patients, especially children, who may be exposed to elevated environmental temperatures or who are febrile.

The use of phenylephrine in the eye may liberate pigment granules from the iris. Mydriatics may produce a transient elevation of intraocular pressure. Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution.

Patient should be advised not to drive or engage in hazardous activities while pupils are dilated. Patient may experience sensitivity to light. Carcinogenesis, Mutagenesis, Impairment of Fertility There have been no long-term studies done using cyclopentolate hydrochloride and/or phenylephrine hydrochloride in animals to evaluate carcinogenic potential.

Pregnancy Animal reproduction studies have not been conducted with cyclopentolate hydrochloride and/or phenylephrine hydrochloride. It is also not known whether cyclopentolate hydrochloride and/or phenylephrine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) should be given to a pregnant woman only if clearly needed.

Nursing Mothers It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is administered to a nursing woman. Pediatric Use Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients.

Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place. Feeding intolerance may follow ophthalmic use of this product in infants.

It is recommended that feeding be withheld after administration, and to observe infants closely for at least 30 minutes (see PRECAUTIONS ). Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🍼 Nursing Mothers 42 words ▾

Nursing Mothers It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 24 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility There have been no long-term studies done using cyclopentolate hydrochloride and/or phenylephrine hydrochloride in animals to evaluate carcinogenic potential.

📄 Package Label / Principal Display Panel 215 words ▾

PRINCIPAL DISPLAY PANEL NDC 0065-0359-05 Alcon Cyclomydril ® (cyclopentolate hydrochloride, phenylephrine hydrochloride ophthalmic solution) 5 mL Sterile Rx Only Sterile Ophthalmic Solution USUAL DOSAGE: Instill one drop in each eye every five to ten minutes. Read enclosed insert. FOR TOPICAL OPHTHALMIC USE ONLY WARNING: Do not touch dropper tip to any surface as this may contaminate the solution.

INGREDIENTS: Each mL contains: Active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium, boric acid, hydrochloric acid and/or sodium carbonate (to adjust pH), purified water.

STORAGE: Store at 8°-25° C (46° to 77° F). Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA SN: LOT: EXP.: GTIN: 00300650359054 300048632-0821 NDC 0065-0359-05 Alcon Cyclomydril ® (cyclopentolate hydrochloride, phenylephrine hydrochloride ophthalmic solution) Sterile 5 mL Rx Only INGREDIENTS: Each mL contains: Actives: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%.

Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium, boric acid, hydrochloric acid and/or sodium carbonate (to adjust pH), purified water. WARNING: Do not touch dropper tip to any surface as this may contaminate the solution.

USUAL DOSAGE: Instill one drop in each eye every five to ten minutes. Read enclosed insert. STORAGE: Store at 8°-25° C (46° to 77° F).

Printed in USA ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA LOT: EXP.: 300048631-0821

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
11
Units reimbursed last 4 qtrs
55
Gross reimbursed last 4 qtrs
$740.66
Avg / prescription
$67.33
Avg / unit
$13.4665
Latest quarter Q4 2025
11Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 11 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported 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: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 55 units · 0.5 per 100k residents NC South Carolina: no data reported 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: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.50.5
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 North Carolina 0.5 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
2 ml00065-0359-02 361 Rx · $17,573
5 ml this page00065-0359-05 11 Rx · $741
Drug total (last 4 qtrs): 372 Rx · 727 units · $18,313 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 Cyclomydril (this brand).

Top reported reactions

Apnoea24
Oxygen Saturation Decreased10
Abdominal Distension9
Feeding Intolerance8
Gastric Residual Increased8
Vomiting8
Bradycardia6

Age at onset

Neonate4
Infant9
Adult4

Reporter sex

68 reports
Male · 57%
Female · 43%

Serious outcomes

Hospitalization7
Life-threatening3
Death3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 10 1
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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alcon Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 2 ml (00065-0359-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Alcon Laboratories, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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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.