FDA.reportPublic FDA data

Saline Nasal Spray - 8014

Manufacturer
GRAXCELL PHARMACEUTICAL, LLC
Effective date
2017-06-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:15:15

Label at a glance#

ProductNASAL SALINE
Active ingredientSODIUM CHLORIDE
Label structure9 sections

Dosage and administration

upright delivers as a apray, horizontally for a stream, upside down as a drop.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 0.65%

Purpose

OTC - PURPOSE SECTION

Helps to moisturize dry and irritated nasal passage.

Ingredients

INACTIVE INGREDIENT SECTION

Asolution in purified water (USP), made isotonic with sodium phosphate diabasic and sodium phosphate monobasic, with benzyl alcohol and benzalkonium chloride  as preservaitives.

Use

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

upright delivers as a apray, horizontally for a stream, upside down as a drop.

Warnings

WARNINGS SECTION

Use of this container by more than one person may spread infection.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

as a health care professional before use.

Keep out of reach of chlidren.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Saline Nasal Spray product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70795-XXXX-X

GRAXCELL PHARMACEUTICAL, LLC

SALINE NASAL SPRAY

Compare to ingregients in Ocean® Saline Nasal Spray

Ideal for Seasonal Allergies

Helps to moisturize dry and irritated nasal passages from conditions like allergies, cold, flu, sinusitis and rhinitis

  • Safe for Frequent, Daily Nasal Care
  • Natural, Non-Medicated Relief
  • 1.5 FL OZ (44mL) Bottle

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF SAFETY SEAL OVER THE CAP IS BROKEN OR MISSING.

Manufactured For/Distributed by: Graxcell Pharmaceuticals
130 Knickerbocker Ave Bohemia, NY 11716

*This product is not manufactured or distributed by Valaent Consumer Products, distributers of Occean Saline Nasal Spray

Lot:

EXP:

Graxcell SalineNasalGraxcell SalineNasal

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70795-8014-42020-11-16C16284748780-19d75b9d0-5fc8-f424-e053-dadaa90a57ceSaline Nasal Spray - 8014
70795-8014-42020-01-31C16284748780-19d75b9d0-5fc8-f424-e053-dadaa90a57ceSaline Nasal Spray - 8014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70795-8014-4ML - Milliliter70795-8014edff54c4-5bc0-4f8d-984b-df4af411d72e12017-10-13

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70795-801470795-8014-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
BENZYL ALCOHOLLKG8494WBHIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT

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
d3ae284f-3ff3-2f60-e053-2a95a90a204ac07d8aeb-c289-4caf-95cc-4b78c4dd25bb2021-12-21WarningsExact identifier
spl set id: c07d8aeb-c289-4caf-95cc-4b78c4dd25bb

Reported adverse events (FAERS/openFDA)#

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