FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Product NDC
58657-853
Requested package NDC
58657-853-01
11-digit product format
586570853
Labeler code
58657
Product ID
58657-853_4bab5061-fc5e-bd93-e063-6294a90abb9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Method Pharmaceuticals, LLC
Application
ANDA218412
Marketing category
ANDA
Marketing start
2026-02-01
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
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218412-001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-14
A218412-002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-14
A218412-003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218412-001AP1
A218412-002AP1
A218412-003AP1

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 2 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2024-03-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218412-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218412-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218412-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12024-03-148072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218412-001AP11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218412-002AP11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218412-003AP11011fe1cb6892…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218412-001AP115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218412-002AP115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218412-003AP115bbf6a4d5a75…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218412-001AP1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218412-002AP1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218412-003AP1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218412-001AP11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218412-002AP11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218412-003AP11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218412-001AP111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218412-002AP111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218412-003AP111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218412-001AP118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A218412-002AP118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A218412-003AP118072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218412-001AP11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218412-002AP11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218412-003AP11a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Phenylephrine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1232651Internal RxNorm lookup
1666372Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4bab505d-d5c8-8c3b-e063-6394a90ad18aAvailable on FDA.report

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
58657-853-01Phenylephrine Hydrochloride10 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-853-01ML - Milliliter58657-8530b106889-5d59-4e29-9f0f-e85d7fa3a7f312026-05-22

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 HYDROCHLORIDEMethod Pharmaceuticals, LLC4bab505d-d5c8-8c3b-e063-6394a90ad18a2026-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218412
application number: ANDA218412
ndc (package): 58657-853-01
ndc (product): 58657-853
ndc11 (package): 58657085301
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEHainan Poly Pharm. Co., Ltd.8d6973c4-4a69-4d49-9da7-d2a00df83ecb2024-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218412
application number: ANDA218412

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSN4bab505d-d5c8-8c3b-e063-6394a90ad18a1
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSN4bab505d-d5c8-8c3b-e063-6394a90ad18a1
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCD4bab505d-d5c8-8c3b-e063-6394a90ad18a1
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCD4bab505d-d5c8-8c3b-e063-6394a90ad18a1
1666372phenylephrine HCl 10 MG per 1 ML InjectionSY4bab505d-d5c8-8c3b-e063-6394a90ad18a1
1232651phenylephrine hydrochloride 1 % Injectable SolutionSY4bab505d-d5c8-8c3b-e063-6394a90ad18a1
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSY4bab505d-d5c8-8c3b-e063-6394a90ad18a1
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSY4bab505d-d5c8-8c3b-e063-6394a90ad18a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58657-853-015865708530110 mL in 1 VIAL, PHARMACY BULK PACKAGE (58657-853-01) 10 ml2026-02-01NoNoCurrent