CYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP)

Manufacturer: Alcon Laboratories, Inc. | Alcon Research LLC
Effective date: 2024-06-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 15
Source: full-release
Hydrated at: 2026-05-31 21:06:13

Label at a glance#

ProductCyclogyl

Active ingredientCYCLOPENTOLATE HYDROCHLORIDE

Label structure12 sections

Label contents#

Full prescribing information#

Rx Only

DESCRIPTION SECTION

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.

CLINICAL PHARMACOLOGY SECTION

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.

INDICATIONS & USAGE SECTION

INDICATIONS AND USAGE: Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.

CONTRAINDICATIONS SECTION

CONTRAINDICATIONS: Should not be used if the patient is hypersensitive to any component of this preparation.

WARNINGS SECTION

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.

PRECAUTIONS:

PRECAUTIONS SECTION

GENERAL PRECAUTIONS SECTION

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 SECTION

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 SECTION

Drug Interactions: Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

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 SECTION

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.

LACTATION SECTION

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 SECTION

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 SECTION

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

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

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.

OVERDOSAGE SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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.

HOW SUPPLIED SECTION

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.

SPL UNCLASSIFIED SECTION

logo
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134

300051372-1121

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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, edetate disodium, 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.

Alcon
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Product of Spain
Printed in USA

300037977-0520

SN:
LOT:
EXP.:
GTIN: 00300650397155

NDC 0065-0397-15

Alcon

Cyclogyl^® 2%
(cyclopentolate hydrochloride ophthalmic solution, USP)

Sterile 15 mL

Rx Only INGREDIENTS: Each mL contains : Active: cyclopentolate hydrochloride 2%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, 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.:
300037975-0520

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type
1298066	Cyclopentolate (Ophthalmic)	cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution	SCD Active
1298356	CYCLOGYL (Ophthalmic)	cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution [Cyclogyl]	SBD Active
1298070	Cyclopentolate (Ophthalmic)	cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution	SCD Active
1298364	CYCLOGYL (Ophthalmic)	cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution [Cyclogyl]	SBD Active
1298072	Cyclopentolate (Ophthalmic)	cyclopentolate hydrochloride 5 MG/ML Ophthalmic Solution	SCD Active
1298366	CYCLOGYL (Ophthalmic)	cyclopentolate hydrochloride 5 MG/ML Ophthalmic Solution [Cyclogyl]	SBD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1298366	Cyclogyl 0.5 % Ophthalmic Solution	PSN	15
1298356	Cyclogyl 1 % Ophthalmic Solution	PSN	15
1298364	Cyclogyl 2 % Ophthalmic Solution	PSN	15
1298072	cyclopentolate HCl 0.5 % Ophthalmic Solution	PSN	15
1298066	cyclopentolate HCl 1 % Ophthalmic Solution	PSN	15
1298070	cyclopentolate HCl 2 % Ophthalmic Solution	PSN	15
1298356	cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution [Cyclogyl]	SBD	15
1298364	cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution [Cyclogyl]	SBD	15
1298366	cyclopentolate hydrochloride 5 MG/ML Ophthalmic Solution [Cyclogyl]	SBD	15
1298066	cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution	SCD	15
1298070	cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution	SCD	15
1298072	cyclopentolate hydrochloride 5 MG/ML Ophthalmic Solution	SCD	15
1298366	Cyclogyl 0.5 % Ophthalmic Drops	SY	15
1298356	Cyclogyl 1 % Ophthalmic Drops	SY	15
1298356	Cyclogyl 10 MG/ML Ophthalmic Solution	SY	15
1298364	Cyclogyl 2 % Ophthalmic Drops	SY	15
1298364	Cyclogyl 20 MG/ML Ophthalmic Solution	SY	15
1298366	Cyclogyl 5 MG/ML Ophthalmic Solution	SY	15
1298072	cyclopentolate hydrochloride 0.5 % Ophthalmic Solution	SY	15
1298066	cyclopentolate hydrochloride 1 % Ophthalmic Solution	SY	15
1298070	cyclopentolate hydrochloride 2 % Ophthalmic Drops	SY	15

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
da26936b-2875-4173-812f-99a1f7074052	Product name	1	20151215
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0065-0395-15	Cyclogyl	1 in 1 CARTON	SOLUTION/ DROPS	1	15
0065-0395-15	Cyclogyl	15 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	15	15
0065-0396-02	Cyclogyl	1 in 1 CARTON	SOLUTION/ DROPS	1	15
0065-0396-02	Cyclogyl	2 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	2	15
0065-0396-05	Cyclogyl	1 in 1 CARTON	SOLUTION/ DROPS	1	15
0065-0396-05	Cyclogyl	5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	5	15
0065-0396-15	Cyclogyl	1 in 1 CARTON	SOLUTION/ DROPS	1	15
0065-0396-15	Cyclogyl	15 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	15	15
0065-0397-02	Cyclogyl	1 in 1 CARTON	SOLUTION/ DROPS	1	15
0065-0397-02	Cyclogyl	2 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	2	15
0065-0397-05	Cyclogyl	1 in 1 CARTON	SOLUTION/ DROPS	1	15
0065-0397-05	Cyclogyl	5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	5	15
0065-0397-15	Cyclogyl	1 in 1 CARTON	SOLUTION/ DROPS	1	15
0065-0397-15	Cyclogyl	15 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	15	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0395	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20240627_1d008c76-7210-4ace-90fa-7cd22762e12e.zip
0065-0396	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	15	Current NDC, Legacy NDC, 6 package rows	20240627_1d008c76-7210-4ace-90fa-7cd22762e12e.zip
0065-0397	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	15	Current NDC, Legacy NDC, 6 package rows	20240627_1d008c76-7210-4ace-90fa-7cd22762e12e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0395-15	ML - Milliliter	0065-0395	01209c50-df45-4edc-96c3-0144c832d436	1	2012-07-24
0065-0396-02	ML - Milliliter	0065-0396	10b738e1-97ee-4189-b132-b7779c2f5df7	1	2012-07-24
0065-0396-05	ML - Milliliter	0065-0396	47ceaaa9-c7ab-488f-b926-1fc68744884a	1	2012-07-24
0065-0396-15	ML - Milliliter	0065-0396	66cde688-08a6-4839-8948-5c6eb09cbd67	1	2012-07-24
0065-0397-02	ML - Milliliter	0065-0397	88c4d8b0-4c39-496e-9b38-dab434a1e2b2	1	2012-07-24
0065-0397-05	ML - Milliliter	0065-0397	c035097a-e837-4f04-b326-d65b141c1b1b	1	2012-07-24
0065-0397-15	ML - Milliliter	0065-0397	614df824-e4eb-409e-a365-f7eedbfb518b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CYCLOPENTOLATE HYDROCHLORIDE	ACTIVE INGREDIENT	736I6971TE	4
CYCLOPENTOLATE	ACTIVE MOIETY	I76F4SHP7J	4
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	4
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	4
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	4
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Cyclogyl
cyclopentolate hydrochloride
CYCLOPENTOLATE
BENZALKONIUM CHLORIDE
BORIC ACID
EDETATE DISODIUM
SODIUM CARBONATE
HYDROCHLORIC ACID
WATER
POTASSIUM CHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0065-0395	0065-0395-15
0065-0396	0065-0396-02, 0065-0396-05, 0065-0396-15
0065-0397	0065-0397-02, 0065-0397-05, 0065-0397-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CYCLOPENTOLATE HYDROCHLORIDE	736I6971TE	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM CARBONATE	45P3261C7T	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
WATER	059QF0KO0R	IACT
POTASSIUM CHLORIDE	660YQ98I10	IACT
CYCLOPENTOLATE HYDROCHLORIDE	736I6971TE	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM CARBONATE	45P3261C7T	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
WATER	059QF0KO0R	IACT
POTASSIUM CHLORIDE	660YQ98I10	IACT
CYCLOPENTOLATE HYDROCHLORIDE	736I6971TE	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM CARBONATE	45P3261C7T	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 60 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION/ DROPS / OPHTHALMIC	0.14 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	SOLUTION / OPHTHALMIC	0.01 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION/ DROPS / OPHTHALMIC	0.14 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION/ DROPS / OPHTHALMIC	0.14 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	SOLUTION / OPHTHALMIC	0.01 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION/ DROPS / OPHTHALMIC	0.14 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	SOLUTION / OPHTHALMIC	0.01 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	SOLUTION / OPHTHALMIC	0.01 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION/ DROPS / OPHTHALMIC	0.14 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	SOLUTION / OPHTHALMIC	0.01 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION/ DROPS / OPHTHALMIC	0.14 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION/ DROPS / OPHTHALMIC	0.14 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	SOLUTION / OPHTHALMIC	0.01 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION/ DROPS / OPHTHALMIC	0.14 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION/ DROPS / OPHTHALMIC	0.14 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	SOLUTION / OPHTHALMIC	0.01 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION/ DROPS / OPHTHALMIC	0.14 %w/v		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	SOLUTION / OPHTHALMIC	0.01 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	SOLUTION / OPHTHALMIC	0.01 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	SOLUTION / OPHTHALMIC	0.01 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 3 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084108-001	CYCLOGYL	CYCLOPENTOLATE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A084108-001	AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A084108-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084108-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084108-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084108-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084108-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084108-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084108-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084108-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084108-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084108-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084108-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084108-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084108-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084108-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084108-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084108-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084108-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084108-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084108-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A084108-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084108-001	AT	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084108-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084108-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084108-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084108-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084108-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084108-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084108-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084108-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084108-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084108-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084108-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084108-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084108-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A084108-001	AT	1	`a50c72e98297…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084109-001	CYCLOGYL	CYCLOPENTOLATE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982

Observed Orange Book product history#

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084109-001	CYCLOGYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084109-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084109-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084109-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084109-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084109-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084109-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084109-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084109-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084109-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084109-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084109-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084109-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084109-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A084109-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084109-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084109-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084109-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084109-001	AT	1	`cb3db0bc1861…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084110-001	CYCLOGYL	CYCLOPENTOLATE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A084110-001	AT

Observed Orange Book product history#

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084110-001	CYCLOGYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A084110-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084110-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084110-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084110-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084110-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084110-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084110-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084110-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084110-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084110-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084110-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084110-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084110-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084110-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084110-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084110-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084110-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084110-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084110-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084110-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084110-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084110-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084110-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084110-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084110-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084110-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084110-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084110-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084110-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084110-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084110-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084110-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084110-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084110-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084110-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084110-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084110-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084110-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084110-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084110-001	AT	1	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclogyl	CYCLOPENTOLATE HYDROCHLORIDE	Alcon Laboratories, Inc.	1d008c76-7210-4ace-90fa-7cd22762e12e	2024-06-25	Warnings, Adverse reactions	Exact identifier ndc (package): 0065-0397-15 ndc (package): 0065-0397-05 ndc (package): 0065-0395-15 ndc (package): 0065-0397-02 ndc (package): 0065-0396-15 ndc (package): 0065-0396-02 ndc (package): 0065-0396-05 ndc (product): 0065-0397 ndc (product): 0065-0395 ndc (product): 0065-0396 ndc11 (package): 00065039615 ndc11 (package): 00065039705 ndc11 (package): 00065039605 ndc11 (package): 00065039515 ndc11 (package): 00065039715 ndc11 (package): 00065039702 ndc11 (package): 00065039602 spl id: 2fc4fc5f-9c4a-456e-9476-7791f6f9c3c1 spl set id: 1d008c76-7210-4ace-90fa-7cd22762e12e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

CYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP)

Label at a glance#

Label contents#

Full prescribing information#

Rx Only

CLINICAL PHARMACOLOGY SECTION

INDICATIONS & USAGE SECTION

CONTRAINDICATIONS SECTION

WARNINGS SECTION

PRECAUTIONS:

GENERAL PRECAUTIONS SECTION

INFORMATION FOR PATIENTS SECTION

DRUG INTERACTIONS SECTION

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

PREGNANCY SECTION

LACTATION SECTION

PEDIATRIC USE SECTION

GERIATRIC USE SECTION

ADVERSE REACTIONS:

OVERDOSAGE SECTION

DOSAGE & ADMINISTRATION SECTION

HOW SUPPLIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

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DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

Orange Book application contexts#

Orange Book products#

Therapeutic equivalence codes#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

Orange Book products#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

Orange Book products#

Therapeutic equivalence codes#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#