Nasocalm Saline Rinse Mix Packets

Manufacturer
Virexion Health Inc.
Effective date
2025-03-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:14

Label at a glance#

ProductNasocalm Saline Rinse Mix Packets
Active ingredientSODIUM CHLORIDE, SODIUM BICARBONATE
Label structure9 sections

Storage and handling

Store in a cool, dry place. Keep the packets sealed until use.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride (NaCl): 4.05 g

Sodium Bicarbonate (NaHCO₃): 0.45 g

OTC - PURPOSE SECTION

Nasal Irrigation & Congestion Relief

INDICATIONS & USAGE SECTION

1.Helps clear nasal passages and sinuses by flushing out allergens, mucus, and irritants.
2.Relieves nasal congestion due to colds, flu, allergies, and sinusitis.

3.Suitable for daily nasal irrigation and post-surgical nasal care.

WARNINGS SECTION

Warnings

1. For nasal rinse only. Do not ingest.
2. Use only sterile, distilled, or previously boiled and cooled water to avoid infections

OTC - STOP USE SECTION

Discontinue use if nasal irritation, nosebleeds, or persistent discomfort occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

1. Prepare the Solution: Mix one packet with 500 mL (16.91 FL OZ) of sterile or previously boiled and cooled water. Stir until fully dissolved.

2. Perform Nasal Rinse: Lean over a sink, tilt your head slightly, and gently squeeze or pour the solution into one nostril while breathing through your mouth. Allow the solution to drain from the other nostril. Repeat on the other side.

3. After Use: Blow your nose gently to remove excess fluid. Wash your irrigation device thoroughly and let it air dry.

4. Children and infants must be used under adult supervision. For children under 5 years old, please follow the advice of a healthcare professional.

STORAGE AND HANDLING SECTION

Store in a cool, dry place.
Keep the packets sealed until use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85436-005-01Nasocalm Saline Rinse Mix Packets50 in 1 BOXPOWDER501
85436-005-01Nasocalm Saline Rinse Mix Packets4500 mg in 1 PACKETPOWDER45001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85436-005NASOCALM SALINE RINSE MIX PACKETS (SODIUM CHLORIDE (NACL)) POWDER [VIREXION HEALTH INC.]12 package rows20250402_3165de94-3b77-844b-e063-6394a90a7a7a.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
85436-00585436-005-01

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
SODIUM BICARBONATE8MDF5V39QOACTIB

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
3165de94-3b78-844b-e063-6394a90a7a7a3165de94-3b77-844b-e063-6394a90a7a7a2025-03-28WarningsExact identifier
spl id: 3165de94-3b78-844b-e063-6394a90a7a7a
spl set id: 3165de94-3b77-844b-e063-6394a90a7a7a

Reported adverse events (FAERS/openFDA)#

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