Cyclogyl cyclopentolate hydrochloride 5 mg/mL Solution/ Drops — NDC 0065-0395-15 (Billing 00065-0395-15)
This is a package of Cyclogyl cyclopentolate hydrochloride 5 mg/mL Solution/ Drops from Alcon Laboratories, Inc., marketed since Oct 1975 and currently FDA-listed; retail pharmacies pay about $6.40 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0065-0395-15 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0065 labeler · 0395 product · 15 package
- Package marketed since
- Oct 15, 1975
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0300650396059
- Medicaid fills, this package
- 460 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
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007874
- GCN: 33030
- GPI-14 (Medi-Span): 86350020102005
- HICL (First Databank): 003467
- AHFS class code: 52:24.00.00
- RxCUI (RxNorm): 1298066
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 Anticholinergics class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- These drops dilate your pupils and temporarily stop your eyes from auto-focusing, so your doctor can see the full back of your eye and get an accurate reading of your prescription....
- Why did my eye doctor put these drops in my eyes before my exam?
- Blurry vision and light sensitivity are completely expected after these drops and are part of how the medication works. For most adults, things return to normal within 24 hours. Pu...
- How long will my vision be blurry and my eyes sensitive to light?
Patient education
Supplement & herbal interactions
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 | $6.405 | $96.07 / 15 ml |
| Medicaid paysCMS SDUD · 12 mo | $6.56 | $98.34 / 15 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?
- 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 |
|---|---|---|---|---|
| 00065-0395-15 You're viewing this Main listing | 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC | 1975-10-15 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cyclogyl 5 mg/mLthis 00065-0395-15 | Alcon | 1 bottle | $6.405 | — | Availability likely | — |
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 Cyclopentolate 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 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.
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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.
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UNII 660YQ98I10
Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
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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.
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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.
7 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 Alcon Laboratories, Inc. labeler code 00065
- FLUORESCITE fluorescein sodium 100 mg/mL Injection, Solution NDC 0065-0092-65
- Isopto Atropine atropine sulfate 10 mg/mL Solution NDC 0065-0303-55
- Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops NDC 0065-0343-02
- Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops NDC 0065-0349-04
- Mydriacyl tropicamide 10 mg/mL Solution/ Drops NDC 0065-0355-03
- Cyclomydril cyclopentolate hydrochloride and phenylephrine 2 mg/mL; 10 mg/mL Solution/ Drops NDC 0065-0359-02
- Cyclogyl cyclopentolate hydrochloride 10 mg/mL Solution/ Drops NDC 0065-0396-02
- Cyclogyl cyclopentolate hydrochloride 20 mg/mL Solution/ Drops NDC 0065-0397-02
- Alcon Tears Lubricant Eye Drops hypromellose 2910 2910 (4000 MPA.S) 5 mg/mL Solution/ Drops NDC 0065-0408-72
- Betadine povidone-iodine 5 mg/mL Solution NDC 0065-0411-30
- BION TEARS Dextran, Hypromellose 70 1 mg/mL; 2910 (4000 MPA.S) 3 mg/mL Solution/ Drops NDC 0065-0419-18
- GenTeal Tears (Moderate) Dextran 70, Glycerin, Hypromellose 70 1 mg/mL; 2 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-0426-36
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: Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Adults: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days.
Children: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% or 1% solution if necessary. Small Infants: A single instillation of one drop of 0.5% in the eye. To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes.
Observe infant closely for at least 30 minutes following instillation. Individuals with heavily pigmented irides may require higher strengths.
⛔ Contraindications ▾
CONTRAINDICATIONS: Should not be used if the patient is hypersensitive to any component of this preparation.
⚠️ Warnings ▾
WARNINGS: FOR TOPICAL OPHTHALMIC USE ONLY . NOT FOR INJECTION. 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. To minimize absorption, use only 1 drop of 0.5% CYCLOGYL solution per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes.
Observe infants closely for at least 30 minutes following instillation. Mydriatics may produce a transient elevation of intraocular pressure. Therefore, patients with untreated narrow angle glaucoma or anatomically narrow angles may be susceptible to angle closure following administration.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Ocular: Increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae have been reported. Non-ocular: Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances, usually in children, especially with 2% concentration. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people.
This drug produces reactions similar to those of other anticholinergic drugs, but the central nervous system manifestations as noted above are more common. Other toxic manifestations of anticholinergic drugs are skin rash, abdominal distention in infants, unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis and death.
🔄 Drug Interactions ▾
Drug Interactions: Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
🤰 Pregnancy ▾
Pregnancy: Animal reproduction studies have not been conducted with cyclopentolate. It is also not known whether cyclopentolate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cyclopentolate should be administered to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
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, and failure to recognize people.
Feeding intolerance and necrotizing enterocolitis (NEC) in preterm infants may follow ophthalmic use of this product. Cases of NEC have been reported in preterm infants following administration; however, causality has not been established. It is recommended that feeding be withheld for four (4) hours after examination.
Observe infants closely for at least 30 minutes (see WARNINGS).
🧓 Geriatric Use ▾
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🆘 Overdosage ▾
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. Patients exhibiting signs of overdosage should receive supportive care and monitoring.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia). It acts rapidly, but has a shorter duration than atropine. Maximal cycloplegia occurs within 25 to 75 minutes after instillation.
Complete recovery of accommodation usually takes 6 to 24 hours. Complete recovery from mydriasis in some individuals may require several days. Heavily pigmented irides may require more doses than lightly pigmented irides.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: In multiple-dose plastic DROP-TAINER® dispensers: 0.5% CYCLOGYL 1% CYCLOGYL 2% CYCLOGYL 15 mL NDC 0065-0395-15 2 mL NDC 0065-0396-02 2 mL NDC 0065-0397-02 5 mL NDC 0065-0396-05 5 mL NDC 0065-0397-05 15 mL NDC 0065-0396-15 15 mL NDC 0065-0397-15 Storage: Store at 8°C to 25°C (46°F to 77°F). After opening, Cyclogyl can be used until the expiration date on the bottle.
📋 Description ▾
Rx Only DESCRIPTION: CYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP) is an anticholinergic prepared as a sterile, borate buffered, solution for topical ocular use. It is supplied in three strengths. The active ingredient is represented by the structural formula: Each mL of CYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP) contains: Active: cyclopentolate hydrochloride 0.5%, 1% or 2%.
Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride (except 2% strength), sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5. chemical
💬 Information for Patients ▾
Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the solution. A transient burning sensation may occur upon instillation. Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated.
Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration. Feeding intolerance may follow ophthalmic use of this product in infants.
It is recommended that feeding be withheld for 4 hours after examination.
⚠️ Precautions ▾
PRECAUTIONS: General: The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Caution should be observed when considering use of this medication in the presence of Down's syndrome. Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the solution.
A transient burning sensation may occur upon instillation. Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation.
Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for 4 hours after examination.
Drug Interactions: Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies in animals or humans have not been conducted to evaluate the carcinogenic potential of CYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP). Pregnancy: Animal reproduction studies have not been conducted with cyclopentolate.
It is also not known whether cyclopentolate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cyclopentolate should be administered to a pregnant woman 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 cyclopentolate hydrochloride 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, and failure to recognize people. Feeding intolerance and necrotizing enterocolitis (NEC) in preterm infants may follow ophthalmic use of this product. Cases of NEC have been reported in preterm infants following administration; however, causality has not been established.
It is recommended that feeding be withheld for four (4) hours after examination. Observe infants closely for at least 30 minutes (see WARNINGS). Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies in animals or humans have not been conducted to evaluate the carcinogenic potential of CYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP).
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 0065-0395-15 Alcon Cyclogyl ® 0.5% (cyclopentolate hydrochloride ophthalmic solution, USP) 15 mL Sterile INGREDIENTS: Each mL contains: Active: cyclopentolate hydrochloride 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water.
The pH range is between 3.0 and 5.5. FOR TOPICAL OPHTHALMIC USE ONLY. Rx Only USUAL DOSAGE: Instill one or two drops in the eye which can be repeated in five to ten minutes.
Read enclosed insert. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 8° to 25°C (46°-77°F).
After opening Cyclogyl can be used until the expiration date on the bottle. ALCON ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Spain 300037981-0520 SN: LOT: EXP.: GTIN: 00300650395151 NDC 0065-0395-15 Alcon Cyclogyl ® 0.5% (cyclopentolate hydrochloride ophthalmic solution, USP) Sterile 15 mL Rx Only INGREDIENTS: Each mL contains : Active: cyclopentolate hydrochloride 0.5%.
Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.
PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. FOR TOPICAL OPHTHALMIC USE ONLY USUAL DOSAGE: Instill one or two drops in the eye which can be repeated in five to ten minutes if necessary. Read enclosed insert.
STORAGE: Store at 8° to 25°C (46° to 77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA 300037980-0520 LOT: EXP.: NDC 0065-0396-05 Alcon Cyclogyl ® 1% (cyclopentolate hydrochloride ophthalmic solution, USP) 5 mL Sterile INGREDIENTS: Each mL contains : Active: cyclopentolate hydrochloride 1%.
Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.
Rx Only USUAL DOSAGE: Instill one or two drops in the eye which can be repeated in five to ten minutes if necessary. Read enclosed Insert. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.
STORAGE: Store at 8° to 25°C (46° to 77°F). After opening, Cyclogyl can be used until the expiration date on the bottle. FOR TOPICAL OPHTHALMIC USE ONLY.
Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Spain Printed in the USA 300037979 -0520 SN: LOT: EXP.: GTIN: 00300650396059 NDC 0065-0396-05 Alcon Cyclogyl ® 1% (cyclopentolate hydrochloride ophthalmic solution, USP) Sterile 5 mL Rx Only INGREDIENTS: Each mL contains : Active: cyclopentolate hydrochloride 1%. Preservative: benzalkonium chloride 0.01%.
Inactives: boric acid, edetate disodium, potassium chloride, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.
USUAL DOSAGE: Instill one or two drops in the eye which can be repeated in five to ten minutes if necessary. Read enclosed insert. STORAGE: Store at 8° to 25°C (46° to 77°F).
ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA LOT EXP.: 300037978-0520 NDC 0065-0397-15 Alcon Cyclogyl ® 2% (cyclopentolate hydrochloride ophthalmic solution, USP) 15 mL Sterile Rx Only USUAL DOSAGE: Instill one or two drops in the eye which can be repeated in five to ten minutes if necessary. Read enclosed insert.
PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 8° to 25°C (46° to 77°F). After opening, Cyclogyl can be used until the expiration date on the bottle.
INGREDIENTS: Each mL contains : Active: cyclopentolate hydrochloride 2%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, ed… [Excerpted — this section continues on DailyMed.]