SinuCleanse
- Manufacturer
- ASCENT CONSUMER PRODUCTS, INC.
- Effective date
- 2025-12-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-06-01 01:21:41
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
(in each packet)
Sodium Bicarbonate USP 700 mg
Sodium Chloride USP 2300 mg
OTC - PURPOSE SECTION
Purpose
Nasal Wash
INDICATIONS & USAGE SECTION
Uses
Temporarily relieves symptoms associated with
sinusitis, cold, flu or allergies:
-Sneezing
-Runny nose
-Nasal stuffiness
-Post nasal drip
-Removes inhaled irritants (dust, pollen)
-Promotes nasal and sinus drainage
-Helps reduce swelling of nasal membranes
-Moisturizes dry nasal passages
WARNINGS SECTION
Warnings
Stop use and ask a doctor if washing is uncomfortable or symptoms
are not relieved.
Do not use unfiltered tap water, see instructions inside box
for proper water sources.
Do not use if nasal passages are completely blocked or if you have
an ear infection or blocked ears.
OTC - WHEN USING SECTION
When using this product:
-Use by only one person
-Wash with soap and water after each use
-Top rack of dishwasher safe
-Do not heat in microwave
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
DOSAGE & ADMINISTRATION SECTION
Directions
Adults and children 4 years and over: use 1/2 - 1 packet per 4 fl oz (120 mL)up to every two hours as needed
Children under 4 years: Consult a physician
See enclosed instruction sheet for complete directions and proper use
OTHER SAFETY INFORMATION
Other Information
-Inspect saline packets for integrity
-Do not use saline packets if open or torn
-Protect saline packets from excessive heat and moisture
-See saline packets or box for lot # and expiration date
INACTIVE INGREDIENT SECTION
Inactive Ingredients
None
OTC - QUESTIONS SECTION
Questions?
1-888-547-5492
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1542919 | sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal Solution | PSN | 9 |
| 1542919 | sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal Solution | SCD | 9 |
| 1542919 | NaHCO3 700 MG / NaCl 2300 MG Powder for Nasal Solution | SY | 9 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BICARBONATE ION Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20220121 |
| SODIUM CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42829-408-60 | 2025-12-10 | C162847 | 48780-1 | 3b156c62-2ed4-fb37-e063-e6dba90a4e07 | SinuCleanse |
| 42829-408-60 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2ed4-fb37-e063-e6dba90a4e07 | SinuCleanse |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42829-408-60 | SinuCleanse | 60 in 1 CARTON | POWDER, FOR SOLUTION | 60 | 9 | |
| 42829-408-60 | SinuCleanse | 3000 mg in 1 PACKET | POWDER, FOR SOLUTION | 3000 | 9 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM BICARBONATE | ACTIVE INGREDIENT | 8MDF5V39QO | 4 | |
| SODIUM CHLORIDE | ACTIVE INGREDIENT | 451W47IQ8X | 4 | |
| BICARBONATE ION | ACTIVE MOIETY | HN1ZRA3Q20 | 4 | |
| SODIUM CATION | ACTIVE MOIETY | LYR4M0NH37 | 4 |
Products#
Every source-derived product name is available through these pages.
- SinuCleanse
- SODIUM BICARBONATE, SODIUM CHLORIDE
- WATER
- SODIUM BICARBONATE
- SODIUM CATION
- BICARBONATE ION
- SODIUM CHLORIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42829-408 | 42829-408-60 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SinuCleanse | SODIUM BICARBONATE, SODIUM CHLORIDE | ASCENT CONSUMER PRODUCTS, INC. | beb842fa-2373-4f21-9631-ef20ee124584 | 2025-12-10 | Warnings | 42829-408-60 42829-408 42829040860 459b6035-e645-208a-e063-6294a90aef87 beb842fa-2373-4f21-9631-ef20ee124584 |
| SinuCleanse | SODIUM BICARBONATE, SODIUM CHLORIDE | ASCENT CONSUMER PRODUCTS, INC. | ff4df6c5-c85f-406a-89d7-8c2853fd5e10 | 2025-01-31 | Warnings | 42829-408 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
