Sodium Chloride for Irrigation
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Sodium Chloride for Irrigation
- Generic name
- SODIUM CHLORIDE FOR IRRIGATION
- Manufacturer
- B. Braun Medical Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 5bd9b176-0402-4a3f-a6b4-c3f393fc092a
- SPL ID
- 69f7d8f6-65cd-45bd-83f7-7249905a2e72
- Version
- 14
- Effective date
- 2021-08-06
- Source export date
- 2026-09-28
- Source partition
- 6
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:39:15
| Harmonized routes |
|---|
| IRRIGATION |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 016733 | derived:openfda.application_number |
| application number | NDA016733 | openfda.application_number | |
| brand name | Sodium Chloride for Irrigation | openfda.brand_name | |
| generic name | SODIUM CHLORIDE FOR IRRIGATION | openfda.generic_name | |
| manufacturer name | B. Braun Medical Inc. | openfda.manufacturer_name | |
| ndc | package | 0264-7388-60 | openfda.package_ndc |
| ndc | package | 0264-7388-50 | openfda.package_ndc |
| ndc | product | 0264-7388 | openfda.product_ndc |
| ndc11 | package | 00264738850 | derived:openfda.package_ndc |
| ndc11 | package | 00264738860 | derived:openfda.package_ndc |
| rxcui | 486515 | openfda.rxcui | |
| spl id | 69f7d8f6-65cd-45bd-83f7-7249905a2e72 | id | |
| spl set id | 5bd9b176-0402-4a3f-a6b4-c3f393fc092a | set_id | |
| unii | 451W47IQ8X | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS FOR IRRIGATION ONLY. NOT FOR INJECTION. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. Do not warm above 150°F (66°C). After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservatives.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.