Phenylephrine Hydrochloride
- Product NDC
- 14335-442
- 11-digit product format
- 143350442
- Labeler code
- 14335
- Product ID
- 14335-442_13fdb0eb-d8cb-ffd6-e063-6394a90a45ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hainan Poly Pharm. Co., Ltd.
- Application
- ANDA218412
- Marketing category
- ANDA
- Marketing start
- 2024-03-19
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | |
| A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | |
| A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218412-001 | AP1 |
| A218412-002 | AP1 |
| A218412-003 | AP1 |
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 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | 2024-03-14 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A218412-002 | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A218412-003 | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A218412-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | 2024-03-14 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A218412-001 | AP1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218412-002 | AP1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218412-003 | AP1 | 1 | 011fe1cb6892… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218412-001 | AP1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218412-002 | AP1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218412-003 | AP1 | 1 | 5bbf6a4d5a75… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A218412-001 | AP1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A218412-002 | AP1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A218412-003 | AP1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A218412-001 | AP1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A218412-002 | AP1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A218412-003 | AP1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A218412-001 | AP1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A218412-002 | AP1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A218412-003 | AP1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A218412-001 | AP1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A218412-002 | AP1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A218412-003 | AP1 | 1 | 8072bd15b7f6… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218412-001 | AP1 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218412-002 | AP1 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218412-003 | AP1 | 1 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phenylephrine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8d6973c4-4a69-4d49-9da7-d2a00df83ecb | Available on FDA.report |
DailyMed Product Concepts#
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 14335-442-01 | Phenylephrine Hydrochloride | 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION | 10 | 1 | |
| 14335-442-01 | Phenylephrine Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | 1 |
DailyMed Dashboard NDC Coverage#
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 | Method Pharmaceuticals, LLC | 4bab505d-d5c8-8c3b-e063-6394a90ad18a | 2026-02-01 | Warnings, Adverse reactions | 218412 ANDA218412 |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Hainan Poly Pharm. Co., Ltd. | 8d6973c4-4a69-4d49-9da7-d2a00df83ecb | 2024-03-19 | Warnings, Adverse reactions | 218412 ANDA218412 14335-442 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1666372 | phenylephrine HCl 10 MG in 1 ML Injection | PSN | 8d6973c4-4a69-4d49-9da7-d2a00df83ecb | 1 |
| 1232651 | phenylephrine HCl 10 MG/ML Injectable Solution | PSN | 8d6973c4-4a69-4d49-9da7-d2a00df83ecb | 1 |
| 1666372 | 1 ML phenylephrine hydrochloride 10 MG/ML Injection | SCD | 8d6973c4-4a69-4d49-9da7-d2a00df83ecb | 1 |
| 1232651 | phenylephrine hydrochloride 10 MG/ML Injectable Solution | SCD | 8d6973c4-4a69-4d49-9da7-d2a00df83ecb | 1 |
| 1666372 | phenylephrine HCl 10 MG per 1 ML Injection | SY | 8d6973c4-4a69-4d49-9da7-d2a00df83ecb | 1 |
| 1232651 | phenylephrine hydrochloride 1 % Injectable Solution | SY | 8d6973c4-4a69-4d49-9da7-d2a00df83ecb | 1 |
| 1232651 | phenylephrine hydrochloride 100 MG per 10 ML Injectable Solution | SY | 8d6973c4-4a69-4d49-9da7-d2a00df83ecb | 1 |
| 1232651 | phenylephrine hydrochloride 50 MG per 5 ML Injectable Solution | SY | 8d6973c4-4a69-4d49-9da7-d2a00df83ecb | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 14335-442-01 | 14335044201 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (14335-442-01) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2024-03-19 | No | No | Current |