Sterile Hypertonic Saline Solution 7 Sodium Chloride

Manufacturer
JOONEM LLC
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:48:33

Label at a glance#

ProductSterile Hypertonic Saline Solution 7 Sodium Chloride
Active ingredientSODIUM CHLORIDE
Label structure6 sections

Indications and uses

For dry nasal membranes

Dosage and administration

Apply Solution with fingers or swab directly into the nose. Apply 2-3 rounds per nostril to sanitize and moisturize nasal passages 

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 7%

Purpose

OTC - PURPOSE SECTION

Moisturizer

Uses:

INDICATIONS & USAGE SECTION

For dry nasal membranes

Warnings

WARNINGS SECTION

  • NOT FOR INJECTION
  • Only use sealed vials do not use if vial is broken or already open

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Do not use after expiration date
  • Discontinue if you experience any adverse reaction and call your physician

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply Solution with fingers or swab directly into the nose.
  • Apply 2-3 rounds per nostril to sanitize and moisturize nasal passages 

Inactive ingredients

INACTIVE INGREDIENT SECTION

USP Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
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89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80327-009-012024-01-30C16284748780-11030e365-6112-111a-e063-dadaa90a10e2Sterile Hypertonic Saline Solution 7% Sodium Chloride USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80327-009-01Sterile Hypertonic Saline Solution 7 Sodium Chloride5 mL in 1 VIALLIQUID55
80327-009-01Sterile Hypertonic Saline Solution 7 Sodium Chloride1 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80327-009STERILE HYPERTONIC SALINE SOLUTION 7 SODIUM CHLORIDE (SODIUM CHLORIDE) LIQUID [JOONEM LLC]5Current NDC, Legacy NDC, 2 package rows20241225_e7110525-9f9b-5b68-e053-2995a90ac034.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80327-00980327-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB
WATER059QF0KO0RIACT

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
Sterile Hypertonic Saline Solution 7 Sodium ChlorideSODIUM CHLORIDEJOONEM LLCe7110525-9f9b-5b68-e053-2995a90ac0342024-12-23WarningsExact identifier
ndc (package): 80327-009-01
ndc (product): 80327-009
ndc11 (package): 80327000901
spl id: 29f1c913-855a-ff60-e063-6294a90ad936
spl set id: e7110525-9f9b-5b68-e053-2995a90ac034

Reported adverse events (FAERS/openFDA)#

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