Sodium Chloride
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
- Generic name
- SODIUM CHLORIDE
- Manufacturer
- B. Braun Medical Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- cc14fafd-3dcd-4fc8-bdbd-6f355c375768
- SPL ID
- 7d4ee37f-5016-422c-9f66-e675ae22c46a
- Version
- 9
- Effective date
- 2022-02-23
- Source export date
- 2026-09-28
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:14:08
| Harmonized routes |
|---|
| INTRAVENOUS |
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 | 017464 | derived:openfda.application_number |
| application number | NDA017464 | openfda.application_number | |
| brand name | Sodium Chloride | openfda.brand_name | |
| generic name | SODIUM CHLORIDE | openfda.generic_name | |
| manufacturer name | B. Braun Medical Inc. | openfda.manufacturer_name | |
| ndc | package | 0264-1800-31 | openfda.package_ndc |
| ndc | package | 0264-1800-36 | openfda.package_ndc |
| ndc | package | 0264-1800-32 | openfda.package_ndc |
| ndc | product | 0264-1800 | openfda.product_ndc |
| ndc11 | package | 00264180032 | derived:openfda.package_ndc |
| ndc11 | package | 00264180031 | derived:openfda.package_ndc |
| ndc11 | package | 00264180036 | derived:openfda.package_ndc |
| rxcui | 1807631 | openfda.rxcui | |
| rxcui | 1807632 | openfda.rxcui | |
| rxcui | 1807630 | openfda.rxcui | |
| spl id | 7d4ee37f-5016-422c-9f66-e675ae22c46a | id | |
| spl set id | cc14fafd-3dcd-4fc8-bdbd-6f355c375768 | set_id | |
| unii | 451W47IQ8X | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic partial fill container. Prescribing information for drug additives to be administered in this manner should be consulted. Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. If an adverse reaction does occur, discontinue the infusion, 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.