Phenylephrine Hydrochloride

Product NDC: 82260-103
11-digit product format: 822600103
Labeler code: 82260
Product ID: 82260-103_278d0147-c5b0-4d85-80f5-500ec567feed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phenylephrine hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Bausch & Lomb Americas Inc.
Application: NDA203510
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2023-03-31
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N203510-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21
N203510-002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N203510-001	AT
N203510-002	AT

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203510-001	8859623	2033-11-14	U-1594		2014-10-17
N203510-002	8859623	2033-11-14	U-1594		2014-10-17

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 · 88 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
2026-10-15 13:18:30	2026-09	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N203510-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203510-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203510-001	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203510-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203510-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203510-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203510-001	AT	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203510-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203510-001	AT	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203510-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203510-001	AT	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203510-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203510-001	AT	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203510-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203510-001	AT	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203510-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203510-001	AT	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203510-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203510-001	AT	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203510-002	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203510-001	AT	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203510-002	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203510-001	AT	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N203510-002	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203510-001	AT	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N203510-002	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203510-001	AT	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203510-002	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203510-001	AT	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203510-002	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203510-001	AT	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203510-002	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203510-001	AT	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203510-002	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203510-001	AT	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N203510-002	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203510-001	AT	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N203510-002	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203510-001	AT	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203510-002	AT	1	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`4b0b4de00fa7…`

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: 2027-12-31

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
dcd09e27-93ec-463f-8062-a7dad96c4d0f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82260-103-05	Phenylephrine Hydrochloride	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		2
82260-103-05	Phenylephrine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82260-103-05	ML - Milliliter	82260-103	7b2b4318-b854-4b8c-a588-65d6b2c3c1f9	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82260-103	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.]	2	Current NDC, 2 package rows	20230727_dcd09e27-93ec-463f-8062-a7dad96c4d0f.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	Paragon BioTeck, Inc.	a4d3fe20-f063-11e0-ac29-0002a5d5c51b	2023-06-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203510 application number: NDA203510
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Bausch & Lomb Americas Inc.	dcd09e27-93ec-463f-8062-a7dad96c4d0f	2023-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203510 application number: NDA203510 ndc (product): 82260-103

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	dcd09e27-93ec-463f-8062-a7dad96c4d0f	2
1234579	phenylephrine hydrochloride 25 MG/ML Ophthalmic Solution	SCD	dcd09e27-93ec-463f-8062-a7dad96c4d0f	2
1234579	phenylephrine hydrochloride 2.5 % Ophthalmic Solution	SY	dcd09e27-93ec-463f-8062-a7dad96c4d0f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82260-103-05	82260010305	1 BOTTLE, DROPPER in 1 CARTON (82260-103-05) / 5 mL in 1 BOTTLE, DROPPER	2023-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenylephrine Hydrochloride	Bausch & Lomb Americas Inc. \| Jubilant HollisterStier General Partnership	2023-03-31	HUMAN PRESCRIPTION DRUG LABEL	2