Phenylephrine Hydrochloride

Product NDC: 42702-103
11-digit product format: 427020103
Labeler code: 42702
Product ID: 42702-103_ff463c02-5533-c9ad-e053-6294a90a7035
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phenylephrine hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Paragon BioTeck, Inc.
Application: NDA203510
Marketing category: NDA
Marketing start: 2013-04-15
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
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 · 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	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…`
2019-12-13 00:20 UTC	2019-12	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`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	N203510-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203510-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203510-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203510-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203510-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203510-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203510-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203510-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203510-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203510-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203510-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203510-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203510-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203510-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203510-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203510-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203510-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203510-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203510-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203510-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203510-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203510-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203510-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203510-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203510-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203510-002	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203510-001	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203510-002	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203510-001	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203510-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203510-001	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203510-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203510-001	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203510-002	AT	1	`4b0b4de00fa7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
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…`
2019-12-13 00:20 UTC	2019-12	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`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
a4d3fe20-f063-11e0-ac29-0002a5d5c51b	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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42702-103-05	2023-02-02	C162847	48780-1	f386c649-fa82-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10% safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10%. PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10%, for topical ophthalmic use Initial U.S. Approval: 1939
42702-103-05	2023-01-30	C162847	48780-1	f386c649-fa82-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10% safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10%. PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10%, for topical ophthalmic use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42702-103-05	Phenylephrine Hydrochloride	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		14
42702-103-05	Phenylephrine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42702-103-05	ML - Milliliter	42702-103	5b40d1be-36e5-4cde-87a9-61f1c257dc6c	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
phenylephrine hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]	2
phenylephrine	ACTIVE MOIETY	1WS297W6MV	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]	2
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]	2
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]	2
sodium phosphate, dibasic	INACTIVE INGREDIENT	GR686LBA74	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]	2
sodium phosphate, monobasic	INACTIVE INGREDIENT	3980JIH2SW	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42702-103	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20230810_a4d3fe20-f063-11e0-ac29-0002a5d5c51b.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 ndc (product): 42702-103
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

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	a4d3fe20-f063-11e0-ac29-0002a5d5c51b	14
1234579	phenylephrine HCl 2.5 % Ophthalmic Solution	PSN	a4d3fe20-f063-11e0-ac29-0002a5d5c51b	14
1234571	phenylephrine hydrochloride 100 MG/ML Ophthalmic Solution	SCD	a4d3fe20-f063-11e0-ac29-0002a5d5c51b	14
1234579	phenylephrine hydrochloride 25 MG/ML Ophthalmic Solution	SCD	a4d3fe20-f063-11e0-ac29-0002a5d5c51b	14
1234571	phenylephrine hydrochloride 10 % Ophthalmic Solution	SY	a4d3fe20-f063-11e0-ac29-0002a5d5c51b	14
1234579	phenylephrine hydrochloride 2.5 % Ophthalmic Solution	SY	a4d3fe20-f063-11e0-ac29-0002a5d5c51b	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42702-103-05	42702010305	1 BOTTLE, DROPPER in 1 CARTON (42702-103-05) / 5 mL in 1 BOTTLE, DROPPER	2013-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenylephrine Hydrochloride	Paragon BioTeck, Inc. \| Jubilant HollisterStier General Partnership	2023-06-29	HUMAN PRESCRIPTION DRUG LABEL	14