FDA.reportPublic FDA data

cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution [Cyclogyl]

RxCUI
1298356
RxNorm name
cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution [Cyclogyl]
Display name
CYCLOGYL (Ophthalmic)
Full name
cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution [Cyclogyl]
Term type
SBD
Status
Active
Strength
1%
Dose form
Sol
Route
Ophthalmic
Updated
2026-07-22 07:07:51

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 hydrochloride10 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, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRCyclogyl 1 % Ophthalmic DropsNAMES
RxNorm Namecyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution [Cyclogyl]NAMES
RxNorm SynonymCyclogyl 1 % Ophthalmic DropsNAMES
RxNorm SynonymCyclogyl 10 MG/ML Ophthalmic SolutionNAMES
TTYSBDATTRIBUTES
SPL_SET_ID1d008c76-7210-4ace-90fa-7cd22762e12eCODES
RxCUI1298356CODES
MMSL_CODEBD384CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0065-0396-020065-0396Cyclogyl cyclopentolate hydrochlorideAlcon Laboratories, Inc.ANDA084110
0065-0396-050065-0396Cyclogyl cyclopentolate hydrochlorideAlcon Laboratories, Inc.ANDA084110

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA0841100065-0396Cyclogyl cyclopentolate hydrochlorideANDAAlcon Laboratories, Inc.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00065039602rxnav_ndcsyes
00065039605rxnav_ndcsyes
00065039615rxnav_historical
00247199802rxnav_historical
54569308700rxnav_historical
54868065600rxnav_historical
54868065601rxnav_historical
58016646801rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
1d008c76-7210-4ace-90fa-7cd22762e12eCyclogyl 1 % Ophthalmic DropsSY15CYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP)20240625
1d008c76-7210-4ace-90fa-7cd22762e12ecyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution [Cyclogyl]SBD15CYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP)20240625
1d008c76-7210-4ace-90fa-7cd22762e12eCyclogyl 1 % Ophthalmic SolutionPSN15CYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP)20240625
1d008c76-7210-4ace-90fa-7cd22762e12eCyclogyl 10 MG/ML Ophthalmic SolutionSY15CYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP)20240625

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

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_STRENGTH10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESANDAANDA084110
CODESMMSL_CODEBD384
CODESRxCUI1298356
CODESSPL_SET_ID1d008c76-7210-4ace-90fa-7cd22762e12e
NAMESPrescribable SynonymCyclogyl 1 % Ophthalmic Solution
NAMESRXNAV_STRCyclogyl 1 % Ophthalmic Drops
NAMESRxNorm Namecyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution [Cyclogyl]
NAMESRxNorm SynonymCyclogyl 1 % Ophthalmic Drops
NAMESRxNorm SynonymCyclogyl 10 MG/ML Ophthalmic Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon