FDA.reportPublic FDA data

Cyclomydril

Product NDC
0065-0359
11-digit product format
000650359
Labeler code
0065
Product ID
0065-0359_3c5dad7d-4db2-4615-92cb-01ea4d769adf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclopentolate hydrochloride and phenylephrine hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
ANDA084300
Marketing category
ANDA
Marketing start
1958-06-30
Substance
CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2; 10 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclomydril
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOPENTOLATE HYDROCHLORIDE2 mg/mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii736I6971TE, 04JA59TNSJ
Rxcui1298068, 1298360

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
da26936b-2875-4173-812f-99a1f7074052Product name120151215
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0359-02Cyclomydril2 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS213
0065-0359-05Cyclomydril5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0359-02ML - Milliliter0065-03593047c504-b1b6-4875-9d0c-cef8add6b84612012-07-24
0065-0359-05ML - Milliliter0065-0359ef866a71-65f9-4955-9af7-572eb6a459db12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOPENTOLATE HYDROCHLORIDEACTIVE INGREDIENT736I6971TECYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]5
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]5
CYCLOPENTOLATEACTIVE MOIETYI76F4SHP7JCYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]5
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]5
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]5
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]5
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TCYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RCYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0359CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]13Current NDC, Legacy NDC, 2 package rows20250519_8268b70f-3f10-48dd-bb24-baaeb27a1325.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298360Cyclomydril 0.2 % / 1 % Ophthalmic SolutionPSN8268b70f-3f10-48dd-bb24-baaeb27a132513
1298068cyclopentolate HCl 0.2 % / phenylephrine HCl 1 % Ophthalmic SolutionPSN8268b70f-3f10-48dd-bb24-baaeb27a132513
1298360cyclopentolate hydrochloride 2 MG/ML / phenylephrine hydrochloride 10 MG/ML Ophthalmic Solution [Cyclomydril]SBD8268b70f-3f10-48dd-bb24-baaeb27a132513
1298068cyclopentolate hydrochloride 2 MG/ML / phenylephrine hydrochloride 10 MG/ML Ophthalmic SolutionSCD8268b70f-3f10-48dd-bb24-baaeb27a132513
1298360Cyclomydril (cyclopentolate hydrochloride 0.2 % / phenylephrine hydrochloride 1 % ) Ophthalmic DropsSY8268b70f-3f10-48dd-bb24-baaeb27a132513
1298068cyclopentolate hydrochloride 0.2 % / phenylephrine hydrochloride 1 % Ophthalmic DropsSY8268b70f-3f10-48dd-bb24-baaeb27a132513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-0359-02000650359022 mL in 1 BOTTLE, PLASTIC (0065-0359-02) 2 ml1958-06-300000-00-00NoNoCurrent
0065-0359-05000650359055 mL in 1 BOTTLE, PLASTIC (0065-0359-05) 5 ml1958-06-300000-00-00NoNoCurrent