FDA.reportPublic FDA data

Saline Nasal Spray

Manufacturer
Healthlife of USA | Kingston Pharma LLC
Effective date
2018-01-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:04:59

Label at a glance#

ProductSaline
Active ingredientSODIUM CHLORIDE
Label structure9 sections

Indications and uses

for dry nasal membranes squeeze twice in each nostril as needed.

Dosage and administration

upright delivers as a spray, horizontally as a stream, upside down as a drop.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 0.65%

Purpose 

OTC - PURPOSE SECTION

For allergies: cold, flu, sinusitis, rhinitis and dry irritated nasal passages

Ingredients 

INACTIVE INGREDIENT SECTION

A solution of sodium chloride 0.65% in purified water (USP), made isotonic with sodium phosphate dibasic and sodium phosphate monobasic, with benzyl alcohol and benzalkonium chloride as preservatives.

Uses

INDICATIONS & USAGE SECTION

for dry nasal membranes squeeze twice in each nostril as needed.

Directions

DOSAGE & ADMINISTRATION SECTION

upright delivers as a spray, horizontally as a stream, upside down as a drop.

Warnings

WARNINGS SECTION

If pregnant or breast-feeding, ask a healthcare professional before use. Use of this container by more than one person may spread infection.

Keep out of reach  of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-844-832-1138

*This product is not manufactured or distributed by Valeant Consumer Products, Distributors of Ocean Saline Nasal Spray.

Saline Nasal Spray 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed by:

Healthlife of USA

1600 Hart Street,

Rahway, NJ 07065

www.healthlifeofusa.com

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69517-609-192023-10-22C16284748780-19d75b9d0-68d1-f424-e053-dadaa90a57ceSaline Nasal Spray
69517-609-192020-01-31C16284748780-19d75b9d0-68d1-f424-e053-dadaa90a57ceSaline Nasal Spray

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-60969517-609-19

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
BENZYL ALCOHOLLKG8494WBHIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
08470a52-4d52-8699-e063-6394a90ac90170bfb707-e86e-44da-9a2e-f18f813481802023-10-21WarningsExact identifier
spl set id: 70bfb707-e86e-44da-9a2e-f18f81348180

Reported adverse events (FAERS/openFDA)#

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