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 (canonical bytes are SHA-256 checked before publication)

Brand name: Sterile Water
Generic name: WATER
Manufacturer: Fresenius Kabi USA, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: fd823bef-c14c-4708-a18a-8aaa8470412f
SPL ID: 7cd9f528-a5da-4541-bb2a-28f3669a6b42
Version: 4
Effective date: 2025-11-18
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 05:34:45

Harmonized routes table
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.

Harmonized identifiers page 1 of 1 · 24 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	216123	derived:openfda.application_number
application number		ANDA216123	openfda.application_number
brand name		Sterile Water	openfda.brand_name
generic name		WATER	openfda.generic_name
manufacturer name		Fresenius Kabi USA, LLC	openfda.manufacturer_name
ndc	package	65219-497-02	openfda.package_ndc
ndc	package	65219-499-03	openfda.package_ndc
ndc	package	65219-495-01	openfda.package_ndc
ndc	package	65219-497-20	openfda.package_ndc
ndc	package	65219-495-10	openfda.package_ndc
ndc	package	65219-499-30	openfda.package_ndc
ndc	product	65219-497	openfda.product_ndc
ndc	product	65219-499	openfda.product_ndc
ndc	product	65219-495	openfda.product_ndc
ndc11	package	65219049720	derived:openfda.package_ndc
ndc11	package	65219049510	derived:openfda.package_ndc
ndc11	package	65219049930	derived:openfda.package_ndc
ndc11	package	65219049903	derived:openfda.package_ndc
ndc11	package	65219049501	derived:openfda.package_ndc
ndc11	package	65219049702	derived:openfda.package_ndc
rxcui		150985	openfda.rxcui
spl id		7cd9f528-a5da-4541-bb2a-28f3669a6b42	id
spl set id		fd823bef-c14c-4708-a18a-8aaa8470412f	set_id
unii		059QF0KO0R	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Sterile Water for Irrigation is hypotonic and will cause hemolysis, and is not recommended for use during surgical procedures. 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 preservative.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS None known. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.