Balanced Salt
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
- Balanced Salt
- Generic name
- SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE
- Manufacturer
- B. Braun Medical Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 74ab8883-0a5f-46b4-8998-9358f6fd4ef4
- SPL ID
- e2d4babc-3f0e-454c-ba77-e2f82fddff51
- Version
- 2
- Effective date
- 2024-03-13
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:27:08
| 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 | ANDA | 091387 | derived:openfda.application_number |
| application number | ANDA091387 | openfda.application_number | |
| brand name | Balanced Salt | openfda.brand_name | |
| generic name | SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE | openfda.generic_name | |
| manufacturer name | B. Braun Medical Inc. | openfda.manufacturer_name | |
| ndc | package | 0264-1945-10 | openfda.package_ndc |
| ndc | product | 0264-1945 | openfda.product_ndc |
| ndc11 | package | 00264194510 | derived:openfda.package_ndc |
| rxcui | 806392 | openfda.rxcui | |
| spl id | e2d4babc-3f0e-454c-ba77-e2f82fddff51 | id | |
| spl set id | 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 | set_id | |
| unii | 02F3473H9O | openfda.unii | |
| unii | 451W47IQ8X | openfda.unii | |
| unii | 1Q73Q2JULR | openfda.unii | |
| unii | 660YQ98I10 | openfda.unii | |
| unii | M4I0D6VV5M | openfda.unii | |
| unii | 4550K0SC9B | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless overwrap is intact, product is clear, seal is intact, and container is undamaged. Do not use if product is discolored or contains a precipitate. SINGLE patient use only. The contents of this container should not be used in more than one patient. This solution contains no preservative, unused contents should be discarded.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy. Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.