FDA.reportPublic FDA data

SinuCleanse Sterile Saline Mist Daily Care

Manufacturer
ASCENT CONSUMER PRODUCTS, INC
Effective date
2022-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:31

Label at a glance#

ProductSinuCleanse Sterile Saline Mist Daily Care
Active ingredientSODIUM CHLORIDE
Label structure9 sections

Indications and uses

Nasal congestion Removes inhaled irritants (dust, dirt, pollen) Moisturizes dry nasal passages

Dosage and administration

Adults and children 4 years and over: Use as often as needed Children under 4 years: Consult a physician See directions on can for complete instructions

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 0.9%

Sterile, Isotonic Saline Solution,

Sodium Bicarbonate USP to adjust pH

Purpose

OTC - PURPOSE SECTION

Nasal Moisturizer

Uses

INDICATIONS & USAGE SECTION

  • Nasal congestion
  • Removes inhaled irritants (dust, dirt, pollen)
  • Moisturizes dry nasal passages

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 4 years and over: Use as often as needed

Children under 4 years: Consult a physician

See directions on can for complete instructions

Warnings

WARNINGS SECTION

Warnings

Use of this product by more than one person may spread infection
Contents under pressure
Do not puncture or incinerate
Avoid spraying in eyes

Other Information

OTHER SAFETY INFORMATION

Store between 59 and 86 degree F

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purfied Water

QUESTIONS ?

OTC - QUESTIONS SECTION

1-888-547-5492

Saline Nasal Spray product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
351179sodium chloride 0.9 % Nasal SprayPSN1
351179sodium chloride 9 MG/ML Nasal SpraySCD1
351179NaCl 9 MG/ML Nasal SpraySY1
351179sodium chloride 0.9 % Nasal SpraySY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42829-504-45SinuCleanse Sterile Saline Mist Daily Care127 g in 1 BOTTLE, SPRAYSPRAY1271
42829-504-75SinuCleanse Sterile Saline Mist Daily Care213 g in 1 BOTTLE, SPRAYSPRAY2131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42829-504SINUCLEANSE STERILE SALINE MIST DAILY CARE (SODIUM CHLORIDE) SPRAY [ASCENT CONSUMER PRODUCTS, INC]1Current NDC, Legacy NDC, 2 package rows20220109_d5131ab2-8213-3659-e053-2a95a90ab2ab.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
42829-50442829-504-45, 42829-504-75

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
WATER059QF0KO0RIACT
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
SinuCleanse Sterile Saline Mist Daily CareSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INCd5131ab2-8213-3659-e053-2a95a90ab2ab2022-01-08WarningsExact identifier
ndc (package): 42829-504-45
ndc (package): 42829-504-75
ndc (product): 42829-504
ndc11 (package): 42829050445
ndc11 (package): 42829050475
spl id: d5131b0b-4c4f-1711-e053-2995a90a5390
spl set id: d5131ab2-8213-3659-e053-2a95a90ab2ab

Reported adverse events (FAERS/openFDA)#

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