0.9% Sodium Chloride Injection

Manufacturer
Baxter Healthcare Corporation | Baxter Healthcare (Shanghai) Co. Ltd.
Effective date
2024-11-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-10 01:06:07

Label at a glance#

ProductSodium Chloride
Active ingredientSODIUM CHLORIDE
Label structure3 sections

Label contents#

Full prescribing information#

HEALTH CARE PROFESSIONAL LETTER

HEALTH CARE PROVIDER LETTER SECTION

DHCP Letter 1.jpg
DHCP Letter 1.jpg
DHCP Letter 2.jpg
DHCP Letter 2.jpg

Please refer to the FDA approved package insert for the full prescribing information of the drug product as follows:
• 0.9% Sodium Chloride Injection, USP (click www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=f55bd888-5e01-474d-871b-24654c070178&type=pdf&name=f55bd888-5e01-474d-871b-24654c070178)

Reporting Adverse Events or Product Quality Issues
To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1- 800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).

To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter Product Feedback Portal (productfeedback.baxter.com)

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DHCP Letter 3.jpg
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DHCP Letter 4.jpg
DHCP Letter 5.jpg
DHCP Letter 5.jpg
DHCP Letter 6.jpg
DHCP Letter 6.jpg

PACKAGE INSERT

SPL UNCLASSIFIED SECTION

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sodium Chloride A6C1322 Representative Container Label.jpg
Sodium Chloride A6C1322 Representative Container Label.jpg

Container Label

Baxter Logo Trademark

A6C1322

SODIUM CHLORIDE INJECTION

50

100

150

200

250ml
0.9% Sodium Chloride

[Strength] 250ml: 2.25g
[Description] This product is a clear, colorless liquid
[Dosage and Administration] Intravenous drip    See the package 
insert for details 
For details of [Indications], [Adverse Reactions],
[Contraindications], and [Precautions], please refer to the
package insert

[Storage] Store in overwrap

The solution should be clear and should be used
up at one time
Inspect the inner bag by squeezing it and discard 
solution if leakage occurs
License Number: H19994066

AA

[Drug Marketing Authorization Holder] [Manufacturer]
Name: Baxter Healthcare (Shanghai) Co., Ltd.
Address: No. 388, Tingzhu Road, Jinshan District, Shanghai

GTIN Barcode Area

LOT
MFG
EXP

Sodium Chloride A6C1323 Representative Container Label.jpg
Sodium Chloride A6C1323 Representative Container Label.jpg

Container Label

Baxter Logo Trademark

A6C1323

SODIUM CHLORIDE INJECTION

100

200

300

400

500ml
0.9% Sodium Chloride

[Strength] 500ml: 4.5g
[Description] This product is a clear, colorless liquid
[Dosage and Administration] Intravenous drip    See the package 
insert for details 
For details of [Indications], [Adverse Reactions],
[Contraindications], and [Precautions], please refer to the
package insert

[Storage] Store in overwrap

The solution should be clear and should be used
up at one time
Inspect the inner bag by squeezing it and discard 
solution if leakage occurs
License Number: H19983148

AA

[Drug Marketing Authorization Holder] [Manufacturer]
Name: Baxter Healthcare (Shanghai) Co., Ltd.
Address: No. 388, Tingzhu Road, Jinshan District, Shanghai

GTIN Barcode Area

LOT
MFG
EXP

Sodium Chloride A6C1324 Representative Container Label.jpg
Sodium Chloride A6C1324 Representative Container Label.jpg

Container Label

Baxter Logo Trademark

A6C1324

SODIUM CHLORIDE INJECTION

100

200

300

400

500

600

700

800

900

1000ml
0.9% Sodium Chloride

[Strength] 1000ml: 9g
[Description] This product is a clear, colorless liquid
[Dosage and Administration] Intravenous drip    See the package 
insert for details 
For details of [Indications], [Adverse Reactions],
[Contraindications], and [Precautions], please refer to the
package insert

[Storage] Store in overwrap

The solution should be clear and should be used
up at one time
Inspect the inner bag by squeezing it and discard 
solution if leakage occurs
License Number: H19983149

AA

[Drug Marketing Authorization Holder] [Manufacturer]
Name: Baxter Healthcare (Shanghai) Co., Ltd.
Address: No. 388, Tingzhu Road, Jinshan District, Shanghai

GTIN Barcode Area

LOT
MFG
EXP

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9804-01ML - Milliliter0338-9804db23dc9a-bd63-43b5-a7d3-0596c4c14f7e12024-12-10
0338-9804-40ML - Milliliter0338-98045a517267-841e-4e63-86c2-149654a14cd712025-03-04
0338-9806-01ML - Milliliter0338-9806665d4930-b364-4304-9997-d77e00ac8a2712024-12-10
0338-9810-01ML - Milliliter0338-9810e60c8647-1222-47b0-9387-d50979e7e23e12024-12-10

Products#

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

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

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-11-21full-release2026-05-31 22:01:45
32024-11-21full-release2026-05-31 21:18:12

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
fb0a01fb-897b-4cc1-9fb4-272a8009e411aaab14e7-a4b4-4b2b-8d73-ba688064a9b12024-11-21Exact identifier
spl set id: aaab14e7-a4b4-4b2b-8d73-ba688064a9b1

Reported adverse events (FAERS/openFDA)#

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