FDA.reportPublic FDA data

Leader Sinus Wash Saline Refill Packets

Manufacturer
Cardinal Health, 110 dba LEADER
Effective date
2025-07-09
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:07:00

Label at a glance#

ProductLeader Sinus Wash Saline Refill Packets
Active ingredientSODIUM BICARBONATE, SODIUM CHLORIDE
Label structure13 sections

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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 for proper water sources.

• Do not use if nasal passages are completely blocked or if you have an ear infection or blocked ears.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children

4 years and over:

 Use 1-2 packets per 8 fl oz(240 mL)

up to every 2 hours as needed

 Children under 4 years: Consult a physician
 See enclosed instruction sheetfor 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

OTC - QUESTIONS SECTION

Questions?

1-888-547-5492

SPL PATIENT PACKAGE INSERT SECTION

image descriptionimage description

SPL PATIENT PACKAGE INSERT SECTION

image descriptionimage description

INACTIVE INGREDIENT SECTION

Inactive Ingredients

None

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1542919sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal SolutionPSN12
1542919sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal SolutionSCD12
1542919NaHCO3 700 MG / NaCl 2300 MG Powder for Nasal SolutionSY12

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
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
70000-0270-1Leader Sinus Wash Saline Refill Packets30 in 1 CARTONPOWDER, FOR SOLUTION3012
70000-0270-1Leader Sinus Wash Saline Refill Packets3 g in 1 PACKETPOWDER, FOR SOLUTION312
70000-0270-2Leader Sinus Wash Saline Refill Packets3 g in 1 PACKETPOWDER, FOR SOLUTION312
70000-0270-2Leader Sinus Wash Saline Refill Packets100 in 1 CARTONPOWDER, FOR SOLUTION10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0270-1EA - Each70000-0270d8ec397a-0781-4762-80d0-ba5d0eebc82112021-11-09
70000-0270-2EA - Each70000-02701339da0a-2663-44c3-b79c-cca606835e8512024-06-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-027070000-0270-1, 70000-0270-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOACTIB
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
Leader Sinus Wash Saline Refill PacketsSODIUM BICARBONATE, SODIUM CHLORIDECardinal Health, 110 dba LEADERfb192a6d-318e-4d2b-89b6-42ac023e4fbd2025-07-09WarningsExact identifier
ndc (package): 70000-0270-1
ndc (package): 70000-0270-2
ndc (product): 70000-0270
ndc11 (package): 70000027002
ndc11 (package): 70000027001
spl id: 3984d390-9318-34b5-e063-6294a90aad2e
spl set id: fb192a6d-318e-4d2b-89b6-42ac023e4fbd

Reported adverse events (FAERS/openFDA)#

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