Phenylephrine Hydrochloride

Product NDC: 72603-520
Requested package NDC: 72603-520-02
11-digit product format: 726030520
Labeler code: 72603
Product ID: 72603-520_e31ea9e0-264f-451a-84f7-578d3445e2dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenylephrine Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: NorthStar RxLLC
Application: ANDA216859
Marketing category: ANDA
Marketing start: 2024-10-01
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 25 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 43.

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
A216859-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216859-001	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.

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
2026-09-14 22:38:34	2026-08	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2022-09-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2022-09-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2022-09-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2022-09-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2022-09-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2022-09-29	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216859-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2022-09-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216859-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216859-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216859-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216859-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216859-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216859-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216859-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216859-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216859-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216859-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216859-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216859-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216859-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216859-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216859-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216859-001	AT	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216859-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216859-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216859-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216859-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216859-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216859-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216859-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216859-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216859-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216859-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216859-001	AT	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216859-001	AT	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A216859-001	CGT	2023-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216859-001	CGT	2023-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216859-001	CGT	2023-04-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216859-001	CGT	2023-04-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216859-001	CGT	2023-04-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216859-001	CGT	2023-04-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216859-001	CGT	2023-04-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216859-001	CGT	2023-04-05	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	25 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
3ce681eb-8580-49bf-962a-68a576fddd57	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72603-520-01	Phenylephrine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	1
72603-520-01	Phenylephrine Hydrochloride	2 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2	1
72603-520-02	Phenylephrine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	1
72603-520-02	Phenylephrine Hydrochloride	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-520-01	ML - Milliliter	72603-520	73c187c5-0a97-4c1a-9490-c7f1312f67d0	1	2025-01-14
72603-520-02	ML - Milliliter	72603-520	aea62892-c6b4-4f9a-a3c2-8499099f8798	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72603-520	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [NORTHSTAR RXLLC]	1	Current NDC, 4 package rows	20241001_3ce681eb-8580-49bf-962a-68a576fddd57.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Lifestar Pharma LLC	f43e4abd-0083-4fe5-9c27-0ba9245e5138	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216859 application number: ANDA216859
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	NorthStar RxLLC	3ce681eb-8580-49bf-962a-68a576fddd57	2024-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216859 application number: ANDA216859 ndc (package): 72603-520-02 ndc (product): 72603-520 ndc11 (package): 72603052002

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	3ce681eb-8580-49bf-962a-68a576fddd57	1
1234579	phenylephrine hydrochloride 25 MG/ML Ophthalmic Solution	SCD	3ce681eb-8580-49bf-962a-68a576fddd57	1
1234579	phenylephrine hydrochloride 2.5 % Ophthalmic Solution	SY	3ce681eb-8580-49bf-962a-68a576fddd57	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72603-520-02	72603052002	1 BOTTLE, DROPPER in 1 CARTON (72603-520-02) / 15 mL in 1 BOTTLE, DROPPER	2024-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenylephrine Hydrochloride	NorthStar RxLLC \| Mankind Pharma Limited	2024-09-02	HUMAN PRESCRIPTION DRUG LABEL	1