Phenylephrine Hydrochloride

Product NDC: 50090-4514
11-digit product format: 500904514
Labeler code: 50090
Product ID: 50090-4514_ac27706a-feef-47ba-b3e8-d95b3303c1e1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenylephrine Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: NDA207926
Marketing category: NDA
Marketing start: 2015-01-15
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 25 mg/mL
Pharmacologic classes: alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-4514		I	Inactivated by FDA		2026-08-10
excluded package	package	50090-4514	50090-4514-0	I	Inactivated by FDA		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4514-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4514-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-4514-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-4514-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-4514-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-4514-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-4514-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-4514-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-4514-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-4514-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-4514-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-4514-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4514-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4514-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4514-0	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207926-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15
N207926-002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N207926-001	AT
N207926-002	AT

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2015-01-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2015-01-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2015-01-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2015-01-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2015-01-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2015-01-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2015-01-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2015-01-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2015-01-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2015-01-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2015-01-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207926-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2015-01-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207926-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2015-01-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207926-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207926-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207926-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207926-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207926-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207926-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207926-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207926-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207926-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207926-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207926-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207926-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207926-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207926-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207926-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207926-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207926-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207926-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207926-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207926-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207926-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207926-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207926-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207926-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207926-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207926-002	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207926-001	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207926-002	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207926-001	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207926-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207926-001	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207926-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207926-001	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207926-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207926-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207926-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207926-001	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207926-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207926-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207926-002	AT	1	`782e0a99824c…`

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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4514-0	2023-01-30	C162847	48780-1	f386c64a-1685-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP. PHENYLEPHRINE HYDROCHLORIDE ophthalmic solution, USP 2.5% and 10%. Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4514-0	Phenylephrine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		7
50090-4514-0	Phenylephrine Hydrochloride	2 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4514-0	ML - Milliliter	50090-4514	41bf601e-f178-460b-af22-091f33680028	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4514	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]	7	Legacy NDC, 2 package rows	20210417_9cfafc70-6218-4de6-9351-cb08e6350e84.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
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Alcon Laboratories, Inc.	cacbb3fd-1c03-4523-a1bf-0ccc4be102ef	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207926 application number: NDA207926

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1234579	phenylephrine HCl 2.5 % Ophthalmic Solution	PSN	9cfafc70-6218-4de6-9351-cb08e6350e84	7
1234579	phenylephrine hydrochloride 25 MG/ML Ophthalmic Solution	SCD	9cfafc70-6218-4de6-9351-cb08e6350e84	7
1234579	phenylephrine hydrochloride 2.5 % Ophthalmic Solution	SY	9cfafc70-6218-4de6-9351-cb08e6350e84	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4514-0	50090451400	1 BOTTLE, DROPPER in 1 CARTON (50090-4514-0) > 2 mL in 1 BOTTLE, DROPPER	2019-09-10	0000-00-00	No	No	Current