Sterile Water
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
- Sterile Water
- Generic name
- WATER
- Manufacturer
- Baxter Healthcare Company
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 210dc9ab-d6ca-4552-ac19-1be17792d290
- SPL ID
- d23ead89-2b87-4348-a785-c10da979513d
- Version
- 13
- Effective date
- 2016-05-31
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:29:09
| 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 | 018632 | derived:openfda.application_number |
| application number | NDA018632 | openfda.application_number | |
| brand name | Sterile Water | openfda.brand_name | |
| generic name | WATER | openfda.generic_name | |
| manufacturer name | Baxter Healthcare Company | openfda.manufacturer_name | |
| ndc | package | 0338-0013-06 | openfda.package_ndc |
| ndc | package | 0338-0013-29 | openfda.package_ndc |
| ndc | package | 0338-0013-08 | openfda.package_ndc |
| ndc | product | 0338-0013 | openfda.product_ndc |
| ndc11 | package | 00338001329 | derived:openfda.package_ndc |
| ndc11 | package | 00338001308 | derived:openfda.package_ndc |
| ndc11 | package | 00338001306 | derived:openfda.package_ndc |
| spl id | d23ead89-2b87-4348-a785-c10da979513d | id | |
| spl set id | 210dc9ab-d6ca-4552-ac19-1be17792d290 | set_id | |
| unii | 059QF0KO0R | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS This solution is for compounding only, not for direct infusion. Hemolysis may occur following infusion of Sterile Water for Injection, USP. Hemoglobin induced renal failure has been reported following hemolysis. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The administration of a suitable admixture of prescribed drugs may be associated with adverse reactions because of the solution or the technique of administration including febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. 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.