FDA.reportPublic FDA data

Neo-Synephrine Hydrochloride

Manufacturer
Hospira, Inc.
Effective date
2021-01-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 20:34:46

Label at a glance#

ProductNeo-Synephrine Hydrochloride
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL - 1 mL Ampule Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 mL
NDC 0409-1800-01

Neo-Synephrine®
HCl

Rx only

phenylephrine HCl
injection, USP

10 mg/mL

1% Solution
Hospira, Inc.
Lake Forest, IL 60045 USA

RL-1423 (11/05)

PRINCIPAL DISPLAY PANEL - 1 mL Ampule Label
PRINCIPAL DISPLAY PANEL - 1 mL Ampule Label

PRINCIPAL DISPLAY PANEL - 1 mL Ampule Cello Pack Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 mL (10 mg)
Single-dose
5 Ampuls
NDC 0409-1800-01

Neo-Synephrine® HCl
phenylephrine hydrochloride injection, USP
1% Sterile Aqueous Injection

FOR PARENTERAL USE
Rx only

PROTECT FROM LIGHT.

Each mL contains 10 mg NEO-SYNEPHRINE hydrochloride,
brand of phenylephrine hydrochloride, 3.5 mg sodium
chloride, 4 mg sodium citrate, 1 mg citric acid monohydrate,
and not more than 2 mg sodium metabisulfite as preservative.
For usual dosage and route of administration, see package
insert. Store at 20 to 25°C (68 to 77°F). [See USP Controlled
Room Temperature.]
WARNING: CONTAINS SULFITES.

Printed in USA
Hospira, Inc., Lake Forest, IL 60045 USA
Hospira

RL-2067 (3/07)

PRINCIPAL DISPLAY PANEL - 1 mL Ampule Cello Pack Label
PRINCIPAL DISPLAY PANEL - 1 mL Ampule Cello Pack Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1232653Neo-Synephrine 10 MG in 1 ML InjectionPSN4
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSN4
12326531 ML phenylephrine hydrochloride 10 MG/ML Injection [Neo-Synephrine]SBD4
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCD4
12326531 ML Neo-Synephrine 10 MG/ML InjectionSY4
1232653Neo-Synephrine 10 MG per 1 ML InjectionSY4
1666372phenylephrine HCl 10 MG per 1 ML InjectionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1800-01Neo-Synephrine Hydrochloride5 in 1 CELLO PACKINJECTION, SOLUTION54
0409-1800-01Neo-Synephrine Hydrochloride1 mL in 1 AMPULEINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1800NEO-SYNEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]42 package rows20210114_120aa498-4834-4855-b74c-a02a93d5cf7f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1800-01ML - Milliliter0409-18009ea889f9-d9af-4d9e-a69e-84386199348b12016-10-06

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0409-18000409-1800-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM METABISULFITE4VON5FNS3CIACT

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
73719d28-525b-4201-94ff-442e81bbb718120aa498-4834-4855-b74c-a02a93d5cf7f2021-01-13Exact identifier
spl id: 73719d28-525b-4201-94ff-442e81bbb718
spl set id: 120aa498-4834-4855-b74c-a02a93d5cf7f

Reported adverse events (FAERS/openFDA)#

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