Phenylephrine Hydrochloride
- Product NDC
- 55154-5129
- 11-digit product format
- 551545129
- Labeler code
- 55154
- Product ID
- 55154-5129_6ba20794-3c97-4981-aa08-5ee41745e33a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Cardinal Health
- Application
- NDA203826
- Marketing category
- NDA
- Marketing start
- 2012-12-18
- Marketing end
- 2020-11-30
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 55154-5129 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 55154-5129 | 55154-5129-5 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55154-5129-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55154-5129-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55154-5129-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55154-5129-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55154-5129-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55154-5129-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55154-5129-5 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55154-5129-5 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 55154-5129-5 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 55154-5129-5 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 55154-5129-5 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 55154-5129-5 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N203826-001 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2012-12-20 |
| N203826-002 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2019-06-19 |
| N203826-003 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2019-06-19 |
| N203826-004 | IMMPHENTIV | PHENYLEPHRINE HYDROCHLORIDE | 0.5MG/5ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | |
| N203826-005 | IMMPHENTIV | PHENYLEPHRINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N203826-001 | AP2 |
| N203826-002 | AP2 |
| N203826-003 | AP2 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N203826-004 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | |
| N203826-004 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | |
| N203826-004 | 12257342 | 2036-09-26 | Drug product | 2025-04-23 | |
| N203826-005 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | |
| N203826-005 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | |
| N203826-005 | 12257342 | 2036-09-26 | Drug product | 2025-04-23 |
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 | 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 | N203826-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2012-12-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203826-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2019-06-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203826-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2019-06-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203826-004 | IMMPHENTIV | 0.5MG/5ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203826-005 | IMMPHENTIV | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2012-12-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2019-06-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2019-06-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-004 | IMMPHENTIV | 0.5MG/5ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-005 | IMMPHENTIV | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203826-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2012-12-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203826-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-06-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203826-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-06-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203826-004 | IMMPHENTIV | 0.5MG/5ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203826-005 | IMMPHENTIV | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203826-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2012-12-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203826-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203826-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203826-004 | IMMPHENTIV | 0.5MG/5ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203826-005 | IMMPHENTIV | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203826-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2012-12-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203826-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203826-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203826-004 | IMMPHENTIV | 0.5MG/5ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203826-005 | IMMPHENTIV | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203826-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2012-12-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203826-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203826-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203826-004 | IMMPHENTIV | 0.5MG/5ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203826-005 | IMMPHENTIV | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203826-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2012-12-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203826-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203826-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203826-004 | IMMPHENTIV | 0.5MG/5ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203826-005 | IMMPHENTIV | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203826-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2012-12-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203826-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-06-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203826-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-06-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203826-004 | IMMPHENTIV | 0.5MG/5ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203826-005 | IMMPHENTIV | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-03-09 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N203826-001 | AP2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203826-002 | AP2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203826-003 | AP2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-001 | AP2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-002 | AP2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-003 | AP2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N203826-001 | AP2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203826-001 | AP2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203826-001 | AP2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203826-001 | AP2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203826-001 | AP2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203826-001 | AP2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203826-001 | AP2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N203826-001 | AP2 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203826-001 | AP2 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203826-001 | AP2 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N203826-001 | AP2 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N203826-001 | AP2 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203826-001 | AP2 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203826-002 | AP2 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203826-003 | AP2 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N203826-001 | AP2 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N203826-002 | AP2 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N203826-003 | AP2 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N203826-001 | AP2 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N203826-002 | AP2 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N203826-003 | AP2 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N203826-001 | AP2 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N203826-002 | AP2 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N203826-003 | AP2 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N203826-001 | AP2 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N203826-002 | AP2 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N203826-003 | AP2 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N203826-001 | AP2 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N203826-002 | AP2 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N203826-003 | AP2 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N203826-001 | AP2 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N203826-002 | AP2 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N203826-003 | AP2 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N203826-001 | AP2 | 1 | 5aa47cf7b7d7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N203826-004 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203826-004 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203826-004 | 12257342 | 2036-09-26 | Drug product | 2025-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203826-005 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203826-005 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203826-005 | 12257342 | 2036-09-26 | Drug product | 2025-04-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-004 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-004 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-004 | 12257342 | 2036-09-26 | Drug product | 2025-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-005 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-005 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203826-005 | 12257342 | 2036-09-26 | Drug product | 2025-04-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203826-004 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203826-004 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203826-004 | 12257342 | 2036-09-26 | Drug product | 2025-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203826-005 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203826-005 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203826-005 | 12257342 | 2036-09-26 | Drug product | 2025-04-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203826-004 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203826-004 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203826-005 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203826-005 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203826-004 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203826-004 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203826-005 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203826-005 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203826-004 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203826-004 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203826-005 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203826-005 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203826-004 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203826-004 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203826-005 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203826-005 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203826-004 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203826-004 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203826-005 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203826-005 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203826-004 | 11471400 | 2036-08-05 | Drug product | 2023-03-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203826-004 | 11213480 | 2036-09-26 | Drug product | 2023-03-22 | d8e5a09893c0… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Civica, Inc. | 7a23ed28-3912-4398-b660-bf9ec3ee3926 | 2024-12-26 | Warnings, Adverse reactions | 203826 NDA203826 |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | c3f358dd-4a36-4808-9943-e01f88604be5 | 2024-04-10 | Warnings, Adverse reactions | 203826 NDA203826 |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 2024-04-09 | Warnings, Adverse reactions | 203826 NDA203826 |
| PHENYLEPHRINE HCI | PHENYLEPHRINE HCI | HF Acquisition Co LLC, DBA HealthFirst | 7602fb73-3ce3-5978-e053-2991aa0abea3 | 2024-02-22 | Warnings, Adverse reactions | 203826 NDA203826 |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | d88a01c4-9681-2695-e053-2995a90a62ea | 2023-05-30 | Warnings, Adverse reactions | 203826 NDA203826 |