Phenylephrine Hydrochloride

Product NDC: 70512-865
11-digit product format: 705120865
Labeler code: 70512
Product ID: 70512-865_45728b25-194d-ddeb-e063-6294a90af4c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenylephrine Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: SOLA Pharmaceuticals, LLC
Application: ANDA215183
Marketing category: ANDA
Marketing start: 2024-06-01
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 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
A215183-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2024-05-23
A215183-002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT		2024-05-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215183-001	AT
A215183-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215183-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215183-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-05-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215183-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215183-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215183-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215183-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215183-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215183-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215183-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215183-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215183-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215183-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215183-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215183-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215183-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215183-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215183-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215183-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215183-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215183-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215183-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215183-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215183-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215183-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215183-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215183-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215183-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215183-002	AT	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215183-001	AT	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215183-002	AT	1	`a50c72e98297…`

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 · 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
bf264b20-6d00-495e-90c7-9172d4535ec7	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
70512-865-02	Phenylephrine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	3
70512-865-02	Phenylephrine Hydrochloride	2 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2	3
70512-865-15	Phenylephrine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	3
70512-865-15	Phenylephrine Hydrochloride	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70512-865-02	ML - Milliliter	70512-865	cb56bd8e-a601-4cd0-bd21-d18abb0716a6	1	2024-07-12
70512-865-15	ML - Milliliter	70512-865	2876bc89-8e9b-4e98-98f3-11ac9eea6673	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70512-865	PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [SOLA PHARMACEUTICALS, LLC]	2	Current NDC, 4 package rows	20240601_bf264b20-6d00-495e-90c7-9172d4535ec7.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	SOLA Pharmaceuticals, LLC	bf264b20-6d00-495e-90c7-9172d4535ec7	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215183 application number: ANDA215183 ndc (product): 70512-865
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Caplin Steriles Limited	1b3eec91-5be5-4010-bf92-4c3e72b39b2a	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215183 application number: ANDA215183
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Leading Pharma, LLC	7543f7e8-fd5f-46d5-a310-ebae71becf44	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215183 application number: ANDA215183

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	bf264b20-6d00-495e-90c7-9172d4535ec7	3
1234579	phenylephrine HCl 2.5 % Ophthalmic Solution	PSN	bf264b20-6d00-495e-90c7-9172d4535ec7	3
1234571	phenylephrine hydrochloride 100 MG/ML Ophthalmic Solution	SCD	bf264b20-6d00-495e-90c7-9172d4535ec7	3
1234579	phenylephrine hydrochloride 25 MG/ML Ophthalmic Solution	SCD	bf264b20-6d00-495e-90c7-9172d4535ec7	3
1234571	phenylephrine hydrochloride 10 % Ophthalmic Solution	SY	bf264b20-6d00-495e-90c7-9172d4535ec7	3
1234579	phenylephrine hydrochloride 2.5 % Ophthalmic Solution	SY	bf264b20-6d00-495e-90c7-9172d4535ec7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70512-865-02	70512086502	1 BOTTLE, DROPPER in 1 CARTON (70512-865-02) / 2 mL in 1 BOTTLE, DROPPER	2024-06-01	No	No	Current
70512-865-15	70512086515	1 BOTTLE, DROPPER in 1 CARTON (70512-865-15) / 15 mL in 1 BOTTLE, DROPPER	2024-06-01	No	No	Current