Sodium Chloride
- Manufacturer
- Baxter Healthcare Company | Baxter Healthcare Ltd
- Effective date
- 2024-11-13
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 21:42:43
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Health Care Provider Letter




Please refer to the FDA-approved prescribing information for the drug product listed below:
• 0.9% Sodium Chloride Irrigation USP (click
dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=886f889b-f3cf-4197-b307-6cfa88c89436)
• Complete and submit the report Online:
www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
• Regular mail or Fax: Download form
www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program 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 this imported product, please contact Baxter Product Surveillance through Baxter Product Feedback Portal (
productfeedback.baxter.com)



PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label
REF 3KB7127 3000 ml
Baxter Logo
eng Sodium Chloride 0.9% for irrigation
UROMATIC container
Isotonic
Nonpyrogenic
Not for injection
Cautions
DO NOT USE FOR ELECTROSURGERY EXCEPT WITH A BIPOLER ELECTRODE
- Do not use unless solution is clear and container is undamaged
- Discard unused content of opened container
- Do not heat this container above 65°C
fre Chlorure de sodium à 0,9% pour irrigation
ger 0,9% Natriumchlorid zum Spülen
ita Sodio cloruro 0.9% per irrigazione
Formula
Natril Chloridum 9 g – Aqua ad injectabilia ad 1000 ml
mOsm/l 308
Do Not Re-Use Symbol
Consult Instructions for Use Symbol
European Conformity Symbol
Temperature Limit 25°C Symbol
Sterile Symbol
Manufacturer Symbol
Baxter Healthcare SA
8010 Zurich, Switzerland
Made in UK
TH-35-02-060
Lot Symbol
Use-by Date Symbol
2500
2000
1500
1000
500
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0338-0110-01 | Sodium Chloride | 3000 mL in 1 BAG | IRRIGANT | 3000 | 2 | |
| 0338-0110-04 | Sodium Chloride | 4 in 1 CARTON | IRRIGANT | 4 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-0110-01 | ML - Milliliter | 0338-0110 | 3a4314ba-a6d6-4587-b43e-584a20651a7e | 1 | 2025-03-04 |
| 0338-0110-04 | ML - Milliliter | 0338-0110 | d5deb64a-20c4-4c08-a364-832aee61de60 | 1 | 2025-03-04 |
Products#
Every source-derived product name is available through these pages.
- Sodium Chloride
- SODIUM CATION
- CHLORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0338-0110 | 0338-0110-01, 0338-0110-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Company | 99a15716-bbb9-4e33-a48d-20c58b81f392 | 2024-11-13 | 0338-0110-01 0338-0110-04 0338-0110 00338011004 00338011001 42b82754-49e1-4463-9679-99a8f443a7d4 99a15716-bbb9-4e33-a48d-20c58b81f392 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.