Phenylephrine hydrochloride

Product NDC
71872-7231
11-digit product format
718727231
Labeler code
71872
Product ID
71872-7231_fae6cee0-57a1-f879-e053-6394a90a1d57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA211081
Marketing category
ANDA
Marketing start
2020-08-12
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

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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71872-7231EExcluded after deficient or non-compliant submission was not corrected2026-08-11
excluded packagepackage71872-723171872-7231-1EExcluded after deficient or non-compliant submission was not corrected2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211081-001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17
A211081-002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17
A211081-003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A211081-001AP1
A211081-002AP1
A211081-003AP1

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 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211081-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211081-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211081-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-07-178072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211081-001AP11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211081-002AP11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211081-003AP11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211081-001AP1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211081-002AP1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211081-003AP1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211081-001AP116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211081-002AP116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211081-003AP116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211081-001AP11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211081-002AP11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211081-003AP11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211081-001AP11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211081-002AP11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211081-003AP11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211081-001AP1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211081-002AP1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211081-003AP1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211081-001AP112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211081-002AP112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211081-003AP112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211081-001AP115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211081-002AP115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211081-003AP115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211081-001AP11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211081-002AP11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211081-003AP11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211081-001AP11d06236e962d9…
2024-10-29 15:01 UTC2024-10A211081-002AP11d06236e962d9…
2024-10-29 15:01 UTC2024-10A211081-003AP11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211081-001AP1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211081-002AP1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211081-003AP1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211081-001AP11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211081-002AP11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211081-003AP11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211081-001AP111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211081-002AP111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211081-003AP111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211081-001AP118072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7231-1Phenylephrine hydrochloride1 in 1 BAGINJECTION12
71872-7231-1Phenylephrine hydrochloride1 mL in 1 VIALINJECTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7231PHENYLEPHRINE HYDROCHLORIDE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20230505_b6358e7a-ecd5-dad5-e053-2995a90aac3f.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDEProvepharm Inc.e1d3881f-fa9e-4d68-8ef0-9e03435fc2922025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211081
application number: ANDA211081
Phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDEMedical Purhasing Solutions, LLC0930ec92-5654-078f-e063-6294a90aad022023-11-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211081
application number: ANDA211081

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSNb6358e7a-ecd5-dad5-e053-2995a90aac3f2
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCDb6358e7a-ecd5-dad5-e053-2995a90aac3f2
1232651phenylephrine hydrochloride 1 % Injectable SolutionSYb6358e7a-ecd5-dad5-e053-2995a90aac3f2
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSYb6358e7a-ecd5-dad5-e053-2995a90aac3f2
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSYb6358e7a-ecd5-dad5-e053-2995a90aac3f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71872-7231-1718727231011 VIAL in 1 BAG (71872-7231-1) / 1 mL in 1 VIAL1 vial2020-11-170000-00-00NoNoCurrent