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#

ProductSodium Chloride
Active ingredientSODIUM CHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Health Care Provider Letter

HEALTH CARE PROVIDER LETTER SECTION

DHCP Letter 1 of 7
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DHCP Letter 2 of 7
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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)

DHCP Letter 5 of 7
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DHCP Letter 6 of 7
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label NDC 0338-0110
Container Label NDC 0338-0110

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

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1000

500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
486515sodium chloride 0.9 % Irrigation SolutionPSN2
486515sodium chloride 0.154 MEQ/ML Irrigation SolutionSCD2
486515NaCl 0.154 MEQ/ML Irrigation SolutionSY2
486515sodium chloride 0.9 % Irrigation SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-0110-01Sodium Chloride3000 mL in 1 BAGIRRIGANT30002
0338-0110-04Sodium Chloride4 in 1 CARTONIRRIGANT42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0110-01ML - Milliliter0338-01103a4314ba-a6d6-4587-b43e-584a20651a7e12025-03-04
0338-0110-04ML - Milliliter0338-0110d5deb64a-20c4-4c08-a364-832aee61de6012025-03-04

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0338-01100338-0110-01, 0338-0110-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB

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
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company99a15716-bbb9-4e33-a48d-20c58b81f3922024-11-13Exact identifier
ndc (package): 0338-0110-01
ndc (package): 0338-0110-04
ndc (product): 0338-0110
ndc11 (package): 00338011004
ndc11 (package): 00338011001
spl id: 42b82754-49e1-4463-9679-99a8f443a7d4
spl set id: 99a15716-bbb9-4e33-a48d-20c58b81f392

Reported adverse events (FAERS/openFDA)#

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