FDA.reportPublic FDA data

SODIUM CHLORIDE

Manufacturer
Baxter Healthcare Corporation | Baxter Hospitalar Ltda.
Effective date
2019-08-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:18:01

Label at a glance#

ProductSODIUM CHLORIDE
Active ingredientSODIUM CHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Health Care Provider Letter

HEALTH CARE PROVIDER LETTER SECTION

DHCP Letter - Image 01
DHCP Letter - Image 01
DHCP Letter - Image 02
DHCP Letter - Image 02
DHCP Letter - Image 03
DHCP Letter - Image 03
DHCP Letter - Image 04
DHCP Letter - Image 04
DHCP Letter - Image 05
DHCP Letter - Image 05

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sodium Chloride Drug Shortage Representative Sample Label
Sodium Chloride Drug Shortage Representative Sample Label

BATCH
EXP
0.9% Sodium Chloride
100mL
VIAFLEX
CLOSURE SYSTEM
STORE AT ROOM TEMPERATURE (15°C TO 30°C)
ADULT AND PEDIATRIC USE EACH 100ML CONTAINS
SODIUM CHLORIDE 900MG WATER FOR INJECTION SUFFICIENT
QUANTITY TO 100ML SODIUM 154 MEQ/L CHLORIDE 154 MEQ/L
pH APPROX 5.0 OSMOLARITY APPROX 308 mOsml/L
INTRAVENOUS ADMINISTRATION STERILE NONPYROGENIC
SOLUTION DO NOT USE IF TURBIDITY IS PRESENT SINGLE USE
DISCARD AFTER USE INFORMATION TO THE HEALTHCARE
PROFESSIONAL INDICATIONS CONTRAINDICATIONS AND
PRECAUTIONS REFER TO PACKAGE INSERT ALL MEDICINES
SHOULD BE KEPT OUT OF THE REACH OF CHILDREN
REMOVE THE OVERPOUCH FOR USE LATEX FREE PRODUCT
RESTRICTED USE FOR HOSPITALS SALE UNDER MEDICAL
PRESCRIPTION
BAXTER
BAXTER HOSPITALAR LTDA
HENRI DUNANT STREET 1383 12º FLOOR TOWER B
CONJ 1201 E 1204 SÃO PAULO SP BRAZIL
CNPJ 49351786000180 BRAZILIAN INDUSTRY
LICENSE NUMBER 1068300690171
TECHNICAL RESPONSIBLE: LUIZ GUSTAVO TANCSIK CRF 67982
CUSTOMER SERVICE 08000125522
BAXTER AND VIAFLEX ARE BRANDS OF BAXTER INTERNATIONAL INC
PRINTED IN BRAZIL
25
50
75
28 25 01 500
FZB1307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9517-16ML - Milliliter0338-951783cb9abc-5eff-43e4-b07a-c4479318802212018-03-08
0338-9517-50ML - Milliliter0338-9517e92e0e06-d5e9-4811-88ed-768ebdd74f4c12018-07-03

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0338-95170338-9517-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB
WATER059QF0KO0RIACT

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
2c996521-145d-4606-a55f-eb1597bc3b637dba97cf-7c58-4b98-8aee-d80b0cb56d412019-08-01Exact identifier
spl id: 2c996521-145d-4606-a55f-eb1597bc3b63
spl set id: 7dba97cf-7c58-4b98-8aee-d80b0cb56d41

Reported adverse events (FAERS/openFDA)#

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