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#
Contacts and useful links#
Label contents#
Full prescribing information#
HEALTH CARE PROFESSIONAL LETTER


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)




PACKAGE INSERT
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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

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

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#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-9804-01 | ML - Milliliter | 0338-9804 | db23dc9a-bd63-43b5-a7d3-0596c4c14f7e | 1 | 2024-12-10 |
| 0338-9804-40 | ML - Milliliter | 0338-9804 | 5a517267-841e-4e63-86c2-149654a14cd7 | 1 | 2025-03-04 |
| 0338-9806-01 | ML - Milliliter | 0338-9806 | 665d4930-b364-4304-9997-d77e00ac8a27 | 1 | 2024-12-10 |
| 0338-9810-01 | ML - Milliliter | 0338-9810 | e60c8647-1222-47b0-9387-d50979e7e23e | 1 | 2024-12-10 |
Products#
Every source-derived product name is available through these pages.
- Sodium Chloride
- SODIUM CATION
- CHLORIDE ION
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0338-9804 | 0338-9804-01, 0338-9804-40 |
| 0338-9806 | 0338-9806-01, 0338-9806-12 |
| 0338-9810 | 0338-9810-01, 0338-9810-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| WATER | 059QF0KO0R | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2024-11-21 | full-release | 2026-05-31 22:01:45 |
| 3 | 2024-11-21 | full-release | 2026-05-31 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| fb0a01fb-897b-4cc1-9fb4-272a8009e411 | aaab14e7-a4b4-4b2b-8d73-ba688064a9b1 | 2024-11-21 | aaab14e7-a4b4-4b2b-8d73-ba688064a9b1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.







