Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye

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: Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye
Generic name: SODIUM CHLORIDE
Manufacturer: Hanlim
Product type: HUMAN OTC DRUG
SPL set ID: 4ee80e16-1bb1-8238-e063-6294a90aa719
SPL ID: 4ee80e25-8e5a-fcc9-e063-6294a90a8884
Version: 1
Effective date: 2026-04-04
Source export date: 2026-10-12
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/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:45:56

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M018	openfda.application_number
brand name		Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	openfda.brand_name
generic name		SODIUM CHLORIDE	openfda.generic_name
manufacturer name		Hanlim	openfda.manufacturer_name
ndc	package	11716-0750-0	openfda.package_ndc
ndc	product	11716-0750	openfda.product_ndc
ndc11	package	11716075000	derived:openfda.package_ndc
rxcui		1298435	openfda.rxcui
spl id		4ee80e25-8e5a-fcc9-e063-6294a90a8884	id
spl set id		4ee80e16-1bb1-8238-e063-6294a90aa719	set_id
unii		451W47IQ8X	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 • For use in the eye s only. • Retain outer carton for full product drug facts. Do not use this product except under the advice and supervision of a doctor. When using this product • avoid contamination, do not touch tip of container to any surface. • replace cap after use. • this product may cause temporary burning and irritation on being instilled into the eye. Stop use and ask a doctor if • you experience eye pain, changes in vision, continued redness or irritation of the eye. • condition worsens or persists for more than 72 hours. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN . If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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