FDA.reportPublic FDA data

cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution [Cyclogyl]

RxCUI
1298364
RxNorm name
cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution [Cyclogyl]
Display name
CYCLOGYL (Ophthalmic)
Full name
cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution [Cyclogyl]
Term type
SBD
Status
Active
Strength
2%
Dose form
Sol
Route
Ophthalmic
Updated
2026-07-22 07:07:59

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
072012
Active start
072012
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
cyclopentolate hydrochloride20 MG / 1 MLcyclopentolatecyclopentolate hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Ophthalmic Solution7670

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
cyclopentolate3001

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRCyclogyl 2 % Ophthalmic Drops1NAMES
RxNorm Namecyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution [Cyclogyl]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID1d008c76-7210-4ace-90fa-7cd22762e12e1CODES
RxCUI12983641CODES
MMSL_CODEBD3871CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0065-0397-020065-0397Cyclogyl cyclopentolate hydrochlorideAlcon Laboratories, Inc.ANDA084108
0065-0397-050065-0397Cyclogyl cyclopentolate hydrochlorideAlcon Laboratories, Inc.ANDA084108
0065-0397-150065-0397Cyclogyl cyclopentolate hydrochlorideAlcon Laboratories, Inc.ANDA084108

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA0841080065-0397Cyclogyl cyclopentolate hydrochlorideANDAAlcon Laboratories, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 7 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00065039702rxnav_ndcsyes
00065039705rxnav_ndcsyes
00065039715rxnav_ndcsyes
00247088805rxnav_historical
54868180100rxnav_historical
54868180101rxnav_historical
55887016915rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyclogylCYCLOPENTOLATE HYDROCHLORIDEAlcon Laboratories, Inc.1d008c76-7210-4ace-90fa-7cd22762e12e2024-06-25Warnings, Adverse reactionsExact identifier
ndc (package): 0065-0397-15
ndc (package): 0065-0397-05
ndc (package): 0065-0397-02
ndc (product): 0065-0397
ndc11 (package): 00065039705
ndc11 (package): 00065039715
ndc11 (package): 00065039702
rxcui: 1298364

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
1d008c76-7210-4ace-90fa-7cd22762e12eCyclogyl 2 % Ophthalmic Solution [PSN] · cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution [Cyclogyl] [SBD] · Cyclogyl 2 % Ophthalmic Drops [SY] · Cyclogyl 20 MG/ML Ophthalmic Solution [SY]415CYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP)20240625

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
1d008c76-7210-4ace-90fa-7cd22762e12eCYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP)Alcon Laboratories, Inc. | Alcon Research LLC20240625
c787db47-6d8d-4672-977a-54f373b79951National Council for Prescription Drug Programs20130303
614df824-e4eb-409e-a365-f7eedbfb518bNational Council for Prescription Drug Programs20120724
88c4d8b0-4c39-496e-9b38-dab434a1e2b2National Council for Prescription Drug Programs20120724
c035097a-e837-4f04-b326-d65b141c1b1bNational Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS01FAAnticholinergicsATC1-4cyclopentolate
MEDRTD003519CyclopentolateCHEMhas_ingredientcyclopentolate
MEDRTD004342Drug HypersensitivityDISEASEci_withcyclopentolate hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withcyclopentolate
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withcyclopentolate hydrochloride
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withcyclopentolate
MEDRTD015878MydriasisDISEASEinducescyclopentolate hydrochloride
MEDRTD015878MydriasisDISEASEinducescyclopentolate
MEDRTN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moacyclopentolate hydrochloride
MEDRTN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moacyclopentolate
MEDRTN0000008779Decreased Parasympathetic Acetylcholine ActivityPEhas_pecyclopentolate hydrochloride
MEDRTN0000008779Decreased Parasympathetic Acetylcholine ActivityPEhas_pecyclopentolate
MEDRTN0000009820Pupillary DilationPEhas_pecyclopentolate hydrochloride
MEDRTN0000009820Pupillary DilationPEhas_pecyclopentolate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH20 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA084108
NAMESPrescribable SynonymCyclogyl 2 % Ophthalmic Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon