FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Manufacturer
Assure Infusions, Inc | Assure Infusions, Inc.
Effective date
2026-03-20
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-06-03 17:59:54

Label at a glance#

ProductPhenylephrine Hydrochloride
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, (+/-)-
Label structure2 sections

Storage and handling

Store at 20 to 25C (68 to 77F). Protect from light.See package insert for complete warnings and directions.

Label contents#

Full prescribing information#

Storage and Handling Section

Store at 20 to 25C (68 to 77F). Protect from light.See package insert for complete warnings and directions.

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label and InsertLabel and Insert

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83155-10783155-107-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CHLORIDE NA-22VMP9781061IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
PHENYLEPHRINE HYDROCHLORIDE, (+/-)-O2VT86KV7EACTIM

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
50af92c9-0b6b-8600-e063-6294a90a81e14c1710e2-68df-b7c9-e063-6394a90a57fc2026-04-30Exact identifier
spl set id: 4c1710e2-68df-b7c9-e063-6394a90a57fc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.