FDA.reportPublic FDA data

Breathe the Sea™ All-Natural Seawater Solution Hypertonic Nasal Spray

Manufacturer
Nasal and Sinus Health, Inc. | Gerolymatos International
Effective date
2012-02-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:31:03

Label at a glance#

ProductBreathe the Sea All-Natural Seawater
Active ingredientSodium Chloride
Label structure9 sections

Dosage and administration

Tilt head forward, spray 2-3 times in each nostril directing spray upward and outward toward ear and away from center of nose. Blow nose. For a more thorough cleansing procedure see the Vanderpool Technique ™ and video demonstration at www.BreatheTheSea.com.

Storage and handling

Contents under pressure. Do not puncture or incinerate. Store at room temperature (59-86°F). Avoid direct exposure to sunlight.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

USES

INDICATIONS & USAGE SECTION

Helps dry congestion related to acute and chronic nasal stuffiness due to irritants, colds, occupational, environmental and home allergens. Provides comfort to congested nasal passages.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Tilt head forward, spray 2-3 times in each nostril directing spray upward and outward toward ear and away from center of nose. Blow nose. For a more thorough cleansing procedure see the Vanderpool Technique ™ and video demonstration at www.BreatheTheSea.com.

PRECAUTIONS

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use with children under 6 years of age except as directed by a physician.

OTC - WHEN USING SECTION

Use of this dispenser by more than one person may spread infection. Avoid spraying in eyes.

CAUTION

STORAGE AND HANDLING SECTION

Contents under pressure. Do not puncture or incinerate. Store at room temperature (59-86°F). Avoid direct exposure to sunlight.

OTC - DO NOT USE SECTION

Do not use if tamper-evident seal is missing or torn from cap.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
Nasal and Sinus Health, Inc.
16 Spring Hill Court
Bluffton, SC 29910

You may report any adverse effects to this address.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Active Ingredient: Seawater 80%

Inactive Ingredient: Purified water 20% Sterilized solution is 2.6% NaCl (sea salt)

PRINCIPAL DISPLAY PANEL - 125 mL Canister Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALL NATURAL SEAWATER
SOLUTION
HYPERTONIC NASAL SPRAY

Breathe
the Sea™

The Every Day Nasal Spray™
Preservative Free

Use 2 – 4 times per day to:

  • Help Dry Congestion
    Due to Colds & Allergies
  • Breathe Easier
  • Soothe and Moisturize
  • Flush out Allergens & Irritants
  • Prewash Nasal Passages

4.22 fl. oz. (125 mL)

Principal Display Panel - 125 mL Canister Label
Principal Display Panel - 125 mL Canister Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245957Breathe the Sea 2.6 % Nasal SprayPSN2
1192851sodium chloride 2.6 % Nasal SprayPSN2
1245957sodium chloride 26 MG/ML Nasal Spray [Breathe the Sea]SBD2
1192851sodium chloride 26 MG/ML Nasal SpraySCD2
1245957Breathe the Sea 0.444 MEQ/ML Nasal SpraySY2
1245957Breathe the Sea 2.6 % Nasal SpraySY2
1245957Breathe the Sea 26 MG/ML Nasal SpraySY2
1192851NaCl 26 MG/ML Nasal SpraySY2
1245957NaCl 26 MG/ML Nasal Spray [Breathe the Sea]SY2
1192851sodium chloride 2.6 % Nasal SpraySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52429-124-012020-01-31C16284748780-19d75b9d1-083d-f424-e053-dadaa90a57ceBreathe the Sea™ All-Natural Seawater Solution Hypertonic Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52429-124-01Breathe the Sea All-Natural Seawater125 mL in 1 CANISTERSPRAY1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52429-124BREATHE THE SEA ALL-NATURAL SEAWATER (SODIUM CHLORIDE) SPRAY [NASAL AND SINUS HEALTH, INC.]2Legacy NDC, 1 package rows20120302_7b890f22-8532-488c-be7e-6ac65bf7248c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X2
Sodium CationACTIVE MOIETYLYR4M0NH372
waterINACTIVE INGREDIENT059QF0KO0R2

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
52429-12452429-124-01

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
42549b28-7afe-4f59-97fc-2dca2ff816bd7b890f22-8532-488c-be7e-6ac65bf7248c2012-02-17WarningsExact identifier
spl id: 42549b28-7afe-4f59-97fc-2dca2ff816bd
spl set id: 7b890f22-8532-488c-be7e-6ac65bf7248c

Reported adverse events (FAERS/openFDA)#

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