BSS

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: BSS
Generic name: BALANCED SALT SOLUTION
Manufacturer: Alcon Laboratories, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 28488c7b-cf6a-4a03-916f-cc66b3afdc57
SPL ID: e84e5d87-f672-4e37-b65b-7f6a93db552a
Version: 13
Effective date: 2023-12-14
Source export date: 2026-10-12
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:29:13

Harmonized routes table
Harmonized routes
OPHTHALMIC

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 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	NDA	020742	derived:openfda.application_number
application number		NDA020742	openfda.application_number
brand name		BSS	openfda.brand_name
generic name		BALANCED SALT SOLUTION	openfda.generic_name
manufacturer name		Alcon Laboratories, Inc.	openfda.manufacturer_name
ndc	package	0065-1795-04	openfda.package_ndc
ndc	product	0065-1795	openfda.product_ndc
ndc11	package	00065179504	derived:openfda.package_ndc
rxcui		806396	openfda.rxcui
rxcui		806392	openfda.rxcui
spl id		e84e5d87-f672-4e37-b65b-7f6a93db552a	id
spl set id		28488c7b-cf6a-4a03-916f-cc66b3afdc57	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 sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless 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 bag 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 sections page 1 of 1 · 1 matching rows.

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.

BSS