Cyclomydril

Product NDC: 0065-0359
Requested package NDC: 0065-0359-05
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A084300-001	CYCLOMYDRIL	CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084300-001	CYCLOMYDRIL	0.2%;1%	SOLUTION/DROPS / OPHTHALMIC	RS, Approved before 1982	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYCLOPENTOLATE HYDROCHLORIDE	2 mg/mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
736I6971TE	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1298068	Internal RxNorm lookup
1298360	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8268b70f-3f10-48dd-bb24-baaeb27a1325	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
da26936b-2875-4173-812f-99a1f7074052	Product name	1	20151215
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0065-0359-02	Cyclomydril	2 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	2		13
0065-0359-05	Cyclomydril	5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	5		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0359-02	ML - Milliliter	0065-0359	3047c504-b1b6-4875-9d0c-cef8add6b846	1	2012-07-24
0065-0359-05	ML - Milliliter	0065-0359	ef866a71-65f9-4955-9af7-572eb6a459db	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYCLOPENTOLATE HYDROCHLORIDE	ACTIVE INGREDIENT	736I6971TE	CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
CYCLOPENTOLATE	ACTIVE MOIETY	I76F4SHP7J	CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0359	CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20250519_8268b70f-3f10-48dd-bb24-baaeb27a1325.zip

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
Cyclomydril	CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Alcon Laboratories, Inc.	8268b70f-3f10-48dd-bb24-baaeb27a1325	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084300 application number: ANDA084300 ndc (package): 0065-0359-05 ndc (product): 0065-0359 ndc11 (package): 00065035905

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
736I6971TE	CYCLOPENTOLATE HYDROCHLORIDE	5870-29-1	CYCLOPENTOLATE HYDROCHLORIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1298360	Cyclomydril 0.2 % / 1 % Ophthalmic Solution	PSN	8268b70f-3f10-48dd-bb24-baaeb27a1325	13
1298068	cyclopentolate HCl 0.2 % / phenylephrine HCl 1 % Ophthalmic Solution	PSN	8268b70f-3f10-48dd-bb24-baaeb27a1325	13
1298360	cyclopentolate hydrochloride 2 MG/ML / phenylephrine hydrochloride 10 MG/ML Ophthalmic Solution [Cyclomydril]	SBD	8268b70f-3f10-48dd-bb24-baaeb27a1325	13
1298068	cyclopentolate hydrochloride 2 MG/ML / phenylephrine hydrochloride 10 MG/ML Ophthalmic Solution	SCD	8268b70f-3f10-48dd-bb24-baaeb27a1325	13
1298360	Cyclomydril (cyclopentolate hydrochloride 0.2 % / phenylephrine hydrochloride 1 % ) Ophthalmic Drops	SY	8268b70f-3f10-48dd-bb24-baaeb27a1325	13
1298068	cyclopentolate hydrochloride 0.2 % / phenylephrine hydrochloride 1 % Ophthalmic Drops	SY	8268b70f-3f10-48dd-bb24-baaeb27a1325	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-0359-05	00065035905	5 mL in 1 BOTTLE, PLASTIC (0065-0359-05)	5 ml	1958-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclomydril ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) Sterile	Alcon Laboratories, Inc. \| Alcon Research LLC	2025-05-15	HUMAN PRESCRIPTION DRUG LABEL	13