warnings
WARNINGS Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.
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
- STERILE WATER
- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 7610bf80-61b7-982f-e053-2a91aa0ac1bb
- SPL ID
- 2b4b21ff-9b0e-65f8-e063-6294a90a7dae
- Version
- 4
- Effective date
- 2025-01-09
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:15:58
| Harmonized routes |
|---|
| INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
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 | 018801 | derived:openfda.application_number |
| application number | NDA018801 | openfda.application_number | |
| brand name | STERILE WATER | openfda.brand_name | |
| generic name | STERILE WATER | openfda.generic_name | |
| manufacturer name | HF Acquisition Co LLC, DBA HealthFirst | openfda.manufacturer_name | |
| ndc | package | 51662-1265-1 | openfda.package_ndc |
| ndc | product | 51662-1265 | openfda.product_ndc |
| ndc11 | package | 51662126501 | derived:openfda.package_ndc |
| spl id | 2b4b21ff-9b0e-65f8-e063-6294a90a7dae | id | |
| spl set id | 7610bf80-61b7-982f-e053-2a91aa0ac1bb | set_id | |
| unii | 059QF0KO0R | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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 this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.