Phenylephrine Hydrochloride

Product NDC: 0065-0343
11-digit product format: 000650343
Labeler code: 0065
Product ID: 0065-0343_c9ffa382-0391-4947-9638-dd7d648a6e38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenylephrine Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: NDA207926
Marketing category: NDA
Marketing start: 2015-01-15
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 100 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 · 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1234571	Internal RxNorm lookup
1234579	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
cacbb3fd-1c03-4523-a1bf-0ccc4be102ef	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0065-0343-02	Phenylephrine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		3
0065-0343-02	Phenylephrine Hydrochloride	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0343-02	ML - Milliliter	0065-0343	0f40919e-808c-4082-a4f0-f16d10386303	1	2025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0343	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	3	Current NDC, 2 package rows	20250403_cacbb3fd-1c03-4523-a1bf-0ccc4be102ef.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 ndc (product): 0065-0343

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
1234571	phenylephrine HCl 10 % Ophthalmic Solution	PSN	cacbb3fd-1c03-4523-a1bf-0ccc4be102ef	3
1234579	phenylephrine HCl 2.5 % Ophthalmic Solution	PSN	cacbb3fd-1c03-4523-a1bf-0ccc4be102ef	3
1234571	phenylephrine hydrochloride 100 MG/ML Ophthalmic Solution	SCD	cacbb3fd-1c03-4523-a1bf-0ccc4be102ef	3
1234579	phenylephrine hydrochloride 25 MG/ML Ophthalmic Solution	SCD	cacbb3fd-1c03-4523-a1bf-0ccc4be102ef	3
1234571	phenylephrine hydrochloride 10 % Ophthalmic Solution	SY	cacbb3fd-1c03-4523-a1bf-0ccc4be102ef	3
1234579	phenylephrine hydrochloride 2.5 % Ophthalmic Solution	SY	cacbb3fd-1c03-4523-a1bf-0ccc4be102ef	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0065-0343-02	00065034302	1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02) / 5 mL in 1 BOTTLE, DROPPER	2025-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenylephrine Hydrochloride	Alcon Laboratories, Inc. \| Alcon Research LLC	2025-04-01	HUMAN PRESCRIPTION DRUG LABEL	3