FDA.reportPublic FDA data

SALISPRAY DAILY SALINE

Manufacturer
PONTIKA AEROTECH LIMITED
Effective date
2024-09-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:55:26

Label at a glance#

ProductSALISPRAY DAILY SALINE
Active ingredientSODIUM CHLORIDE
Label structure8 sections

Indications and uses

Restores vital moisture to provide prompt relief for dry, crusted, and inflamed nasal membranes due to chronic sinusitis, colds, low humidity, overuse of nasal decongestant drops and sprays, allergies, minor nose bleeds, and other minor nasal irritations. Helps remove inhaled irritants such as dust, dirt, and pollen.

Dosage and administration

Read HOW TO USE instructions before use Adults and children 4 years of age an older: Use as often as needed or as directed by a physician Children under 4 years : Consult a physician.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 0.9%

Purpose

OTC - PURPOSE SECTION

Nasal Moisturizer

Uses

INDICATIONS & USAGE SECTION

  • Restores vital moisture to provide prompt relief for dry, crusted, and inflamed nasal membranes due to chronic sinusitis, colds, low humidity, overuse of nasal decongestant drops and sprays, allergies, minor nose bleeds, and other minor nasal irritations.
  • Helps remove inhaled irritants such as dust, dirt, and pollen.

Warnings

WARNINGS SECTION

  • This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.
  • The use of this dispenser by more than one person may spread infection.
  • Avoid spraying in eyes.
  • Content under pressure.
  • Do not puncture or incinerate.
  • Store between 59º and 86º F (15º and 30º C)

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Read HOW TO USE instructions before use

  • Adults and children 4 years of age an older:Use as often as needed or as directed by a physician
  • Children under 4 years: Consult a physician.

Other information

OTHER SAFETY INFORMATION

Do not use if the printed safety seal on the bottle is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Sodium Bicarbonate

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Daily Saline Nasal Mist Sodium Chloride 0.9% - NDC 83376-265-09 - Bottle Label

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83376-265SALISPRAY DAILY SALINE (NASAL MIST) AEROSOL, SPRAY [PONTIKA AEROTECH LIMITED]1Unmatched20240907_07f213f4-c97d-42ae-9160-8a4bbe94f171.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83376-26583376-265-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM CHLORIDE451W47IQ8XACTIB

Source Document#

Source XML

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
4af3d47e-0df4-8259-e063-6394a90adbf307f213f4-c97d-42ae-9160-8a4bbe94f1712026-02-16WarningsExact identifier
spl set id: 07f213f4-c97d-42ae-9160-8a4bbe94f171

Reported adverse events (FAERS/openFDA)#

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