FDA.reportPublic FDA data

SinuCleanse

Product NDC
42829-401
Requested package NDC
42829-401-01
11-digit product format
428290401
Labeler code
42829
Product ID
42829-401_2d073cca-7bcc-d1bd-e063-6294a90a0c39
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM BICARBONATE, SODIUM CHLORIDE
Dosage form
POWDER, FOR SOLUTION
Route
NASAL
Labeler
ASCENT CONSUMER PRODUCTS, INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-02-01
Substance
SODIUM BICARBONATE; SODIUM CHLORIDE
Active strength
700; 2300 mg/3000mg; mg/3000mg
Pharmacologic classes
Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SinuCleanse
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM BICARBONATE700 mg/3000mg
SODIUM CHLORIDE2300 mg/3000mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8MDF5V39QOInternal UNII lookup
451W47IQ8XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1542919Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c33bf872-54aa-45e0-9e40-a6565a13f198Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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
42829-401-01SinuCleanse Neti-Pot3000 mg in 1 PACKETPOWDER, FOR SOLUTION90000 mg2300 mg in 3000mg11
42829-401-01SinuCleanse Squeeze3000 mg in 1 PACKETPOWDER, FOR SOLUTION90000 mg700 mg in 3000mg9
42829-401-02SinuCleanse Micro-Filtered Nasal Wash System30 in 1 KITPOWDER, FOR SOLUTION700 mg in 3000mg9
42829-401-02SinuCleanse Micro-Filtered Nasal Wash System3000 mg in 1 PACKETPOWDER, FOR SOLUTION3000 mg700 mg in 3000mg9
42829-401-01SinuCleanse3000 mg in 1 PACKETPOWDER, FOR SOLUTION30007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOSINUCLEANSE SQUEEZE (SODIUM BICARBONATE, SODIUM CHLORIDE) KIT [ASCENT CONSUMER PRODUCTS, INC.]4
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSINUCLEANSE SQUEEZE (SODIUM BICARBONATE, SODIUM CHLORIDE) KIT [ASCENT CONSUMER PRODUCTS, INC.]4
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q20SINUCLEANSE SQUEEZE (SODIUM BICARBONATE, SODIUM CHLORIDE) KIT [ASCENT CONSUMER PRODUCTS, INC.]4
SODIUM CATIONACTIVE MOIETYLYR4M0NH37SINUCLEANSE SQUEEZE (SODIUM BICARBONATE, SODIUM CHLORIDE) KIT [ASCENT CONSUMER PRODUCTS, INC.]4
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOSINUCLEANSE (SODIUM BICARBONATE, SODIUM CHLORIDE) POWDER, FOR SOLUTION [ASCENT CONSUMER PRODUCTS, INC.]3
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSINUCLEANSE (SODIUM BICARBONATE, SODIUM CHLORIDE) POWDER, FOR SOLUTION [ASCENT CONSUMER PRODUCTS, INC.]3
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q20SINUCLEANSE (SODIUM BICARBONATE, SODIUM CHLORIDE) POWDER, FOR SOLUTION [ASCENT CONSUMER PRODUCTS, INC.]3
SODIUM CATIONACTIVE MOIETYLYR4M0NH37SINUCLEANSE (SODIUM BICARBONATE, SODIUM CHLORIDE) POWDER, FOR SOLUTION [ASCENT CONSUMER PRODUCTS, INC.]3
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOSINUCLEANSE NETI-POT (SODIUM BICARBONATE, SODIUM CHLORIDE) KIT [ASCENT CONSUMER PRODUCTS, INC.]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSINUCLEANSE NETI-POT (SODIUM BICARBONATE, SODIUM CHLORIDE) KIT [ASCENT CONSUMER PRODUCTS, INC.]2
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q20SINUCLEANSE NETI-POT (SODIUM BICARBONATE, SODIUM CHLORIDE) KIT [ASCENT CONSUMER PRODUCTS, INC.]2
SODIUM CATIONACTIVE MOIETYLYR4M0NH37SINUCLEANSE NETI-POT (SODIUM BICARBONATE, SODIUM CHLORIDE) KIT [ASCENT CONSUMER PRODUCTS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42829-401SINUCLEANSE NETI-POT (SODIUM BICARBONATE, SODIUM CHLORIDE) KIT [ASCENT CONSUMER PRODUCTS, INC.]11Current NDC, Legacy NDC20250202_ba953a99-4885-4823-9905-75ce3eae160c.zip
42829-401SINUCLEANSE SQUEEZE (SODIUM BICARBONATE, SODIUM CHLORIDE) KIT [ASCENT CONSUMER PRODUCTS, INC.]9Current NDC, Legacy NDC20250202_e8f7ea0b-0838-40ac-af1c-6a5ca7afbebe.zip
42829-401SINUCLEANSE MICRO-FILTERED NASAL WASH SYSTEM (SODIUM CHLORIDE, SODIUM BICARBONATE) KIT [ASCENT CONSUMER PRODUCTS, INC.]8Current NDC, Legacy NDC20240118_ad9bba62-3503-4659-a190-3e858788c4c3.zip
42829-401SINUCLEANSE (SODIUM BICARBONATE, SODIUM CHLORIDE) POWDER, FOR SOLUTION [ASCENT CONSUMER PRODUCTS, INC.]7Current NDC, Legacy NDC, 1 package rows20250202_c33bf872-54aa-45e0-9e40-a6565a13f198.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SinuCleanse Neti-PotSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.ba953a99-4885-4823-9905-75ce3eae160c2025-01-31WarningsExact identifier
ndc (package): 42829-401-01
ndc11 (package): 42829040101
SinuCleanse SqueezeSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e8f7ea0b-0838-40ac-af1c-6a5ca7afbebe2025-01-31WarningsExact identifier
ndc (package): 42829-401-01
ndc11 (package): 42829040101
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.c33bf872-54aa-45e0-9e40-a6565a13f1982025-01-31WarningsExact identifier
ndc (package): 42829-401-01
ndc (product): 42829-401
ndc11 (package): 42829040101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1542919sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal SolutionPSNba953a99-4885-4823-9905-75ce3eae160c11
1542919sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal SolutionSCDba953a99-4885-4823-9905-75ce3eae160c11
1542919NaHCO3 700 MG / NaCl 2300 MG Powder for Nasal SolutionSYba953a99-4885-4823-9905-75ce3eae160c11
1866164SinuCleanse 700 MG / 2300 MG Powder for Nasal SolutionPSNad9bba62-3503-4659-a190-3e858788c4c39
1542919sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal SolutionPSNad9bba62-3503-4659-a190-3e858788c4c39
1542919sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal SolutionPSNe8f7ea0b-0838-40ac-af1c-6a5ca7afbebe9
1866164sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal Solution [Sinucleanse]SBDad9bba62-3503-4659-a190-3e858788c4c39
1542919sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal SolutionSCDad9bba62-3503-4659-a190-3e858788c4c39
1542919sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal SolutionSCDe8f7ea0b-0838-40ac-af1c-6a5ca7afbebe9
1542919NaHCO3 700 MG / NaCl 2300 MG Powder for Nasal SolutionSYad9bba62-3503-4659-a190-3e858788c4c39
1542919NaHCO3 700 MG / NaCl 2300 MG Powder for Nasal SolutionSYe8f7ea0b-0838-40ac-af1c-6a5ca7afbebe9
1866164NaHCO3 700 MG / NaCl 2300 MG Powder for Nasal Solution [Sinucleanse]SYad9bba62-3503-4659-a190-3e858788c4c39
1866164Sinucleanse 700 MG / 2300 MG Powder for Nasal SolutionSYad9bba62-3503-4659-a190-3e858788c4c39
1542919sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal SolutionPSNc33bf872-54aa-45e0-9e40-a6565a13f1987
1542919sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal SolutionSCDc33bf872-54aa-45e0-9e40-a6565a13f1987
1542919NaHCO3 700 MG / NaCl 2300 MG Powder for Nasal SolutionSYc33bf872-54aa-45e0-9e40-a6565a13f1987

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42829-401-01428290401013000 mg in 1 PACKET (42829-401-01) 3000 mg2015-02-010000-00-00NoNoCurrent