FDA.reportPublic FDA data

cyclopentolate hydrochloride 2 MG/ML / phenylephrine hydrochloride 10 MG/ML Ophthalmic Solution [Cyclomydril]

RxCUI
1298360
RxNorm name
cyclopentolate hydrochloride 2 MG/ML / phenylephrine hydrochloride 10 MG/ML Ophthalmic Solution [Cyclomydril]
Display name
CYCLOMYDRIL (Ophthalmic)
Full name
cyclopentolate hydrochloride 2 MG/ML / phenylephrine hydrochloride 10 MG/ML Ophthalmic Solution [Cyclomydril]
Term type
SBD
Status
Active
Strength
0.2-1%
Dose form
Sol
Route
Ophthalmic
Updated
2026-07-20 06:54:18

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
072012
Active start
072012
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
cyclopentolate hydrochloride2 MG / 1 MLcyclopentolatecyclopentolate hydrochloride
phenylephrine hydrochloride10 MG / 1 MLphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Ophthalmic Solution7670

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
cyclopentolate3001
phenylephrine8163

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRCyclomydril (cyclopentolate hydrochloride 0.2 % / phenylephrine hydrochloride 1 % ) Ophthalmic DropsNAMES
RxNorm Namecyclopentolate hydrochloride 2 MG/ML / phenylephrine hydrochloride 10 MG/ML Ophthalmic Solution [Cyclomydril]NAMES
RxNorm SynonymCyclomydril (cyclopentolate hydrochloride 0.2 % / phenylephrine hydrochloride 1 % ) Ophthalmic DropsNAMES
TTYSBDATTRIBUTES
SPL_SET_ID8268b70f-3f10-48dd-bb24-baaeb27a1325CODES
RxCUI1298360CODES
MMSL_CODEBD3563CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0065-0359-020065-0359Cyclomydril cyclopentolate hydrochloride and phenylephrine hydrochlorideAlcon Laboratories, Inc.ANDA084300
0065-0359-050065-0359Cyclomydril cyclopentolate hydrochloride and phenylephrine hydrochlorideAlcon Laboratories, Inc.ANDA084300

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA0843000065-0359Cyclomydril cyclopentolate hydrochloride and phenylephrine hydrochlorideANDAAlcon Laboratories, Inc.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00065035902rxnav_ndcsyes
00065035905rxnav_ndcsyes
00247088605rxnav_ndcsyes
55887098405rxnav_historical_indirect

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
8268b70f-3f10-48dd-bb24-baaeb27a1325cyclopentolate hydrochloride 2 MG/ML / phenylephrine hydrochloride 10 MG/ML Ophthalmic Solution [Cyclomydril]SBD13Cyclomydril ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) Sterile20250515
8268b70f-3f10-48dd-bb24-baaeb27a1325Cyclomydril (cyclopentolate hydrochloride 0.2 % / phenylephrine hydrochloride 1 % ) Ophthalmic DropsSY13Cyclomydril ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) Sterile20250515
8268b70f-3f10-48dd-bb24-baaeb27a1325Cyclomydril 0.2 % / 1 % Ophthalmic SolutionPSN13Cyclomydril ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) Sterile20250515

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
8268b70f-3f10-48dd-bb24-baaeb27a1325Cyclomydril ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) SterileAlcon Laboratories, Inc. | Alcon Research LLC20250515

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
ATCS01FAAnticholinergicsATC1-4cyclopentolate
ATCC05AXOther agents for treatment of hemorrhoids and anal fissures for topical useATC1-4phenylephrine
ATCR01BASympathomimeticsATC1-4phenylephrine
ATCS01FBSympathomimetics excl. antiglaucoma preparationsATC1-4phenylephrine
ATCS01GASympathomimetics used as decongestantsATC1-4phenylephrine
ATCR01ABSympathomimetics, combinations excl. corticosteroidsATC1-4phenylephrine
ATCR01AASympathomimetics, plainATC1-4phenylephrine
FDASPLN0000186105alpha-1 Adrenergic AgonistEPChas_epcphenylephrine
MEDRTD003519CyclopentolateCHEMhas_ingredientcyclopentolate
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withcyclopentolate hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withcyclopentolate
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withcyclopentolate
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withcyclopentolate hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD015878MydriasisDISEASEinducescyclopentolate hydrochloride
MEDRTD015878MydriasisDISEASEinducescyclopentolate
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moacyclopentolate
MEDRTN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moacyclopentolate hydrochloride
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
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_STRENGTH2 MG/ML / 10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESANDAANDA084300
CODESMMSL_CODEBD3563
CODESRxCUI1298360
CODESSPL_SET_ID8268b70f-3f10-48dd-bb24-baaeb27a1325
NAMESPrescribable SynonymCyclomydril 0.2 % / 1 % Ophthalmic Solution
NAMESRXNAV_STRCyclomydril (cyclopentolate hydrochloride 0.2 % / phenylephrine hydrochloride 1 % ) Ophthalmic Drops
NAMESRxNorm Namecyclopentolate hydrochloride 2 MG/ML / phenylephrine hydrochloride 10 MG/ML Ophthalmic Solution [Cyclomydril]
NAMESRxNorm SynonymCyclomydril (cyclopentolate hydrochloride 0.2 % / phenylephrine hydrochloride 1 % ) Ophthalmic Drops
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon