Cetylpyridinium Chloride

Manufacturer
Publix Super Markets, Inc. | Nice-Pak Products, LLC
Effective date
2026-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:49:42

Label at a glance#

ProductCetylpyridinium Chloride
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure13 sections

Dosage and administration

adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day do not swallow children 6 years to under 12 years of age: supervise use when used after brushing, rinse mouth with water first children under 6 years of age: do not use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.05%

Purpose

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

Use

INDICATIONS & USAGE SECTION

helps control plaque {bacteria} that leads to gingivitis

Warnings

WARNINGS SECTION

for this product

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use

Other information

OTHER SAFETY INFORMATION

  • this rinse is not intended to replace brushing or flossing

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, poloxamer 407, flavor, sucralose, benzoic acid, sodium benzoate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-267-3037

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of TheraBreath ® Healthy Gums Oral Rinse Clean Mint.

Adverse Reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

3300 PUBLIX CORPORATE PARKWAY,

LAKELAND, FL 33811

publix.com

PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK.

SCAN HERE FOR MORE INFORMATION

Publix ®

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL-FREE

CLEAN MINT

Clean Gums

ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

Helps fight gingivits for 12 hours.

Dye-free.

Compare to TheraBreath ® Healthy Gums Oral Rinse Clean Mint.*

Sealed with printed neckband for your protection.

16 FL OZ (1 PT) 473 mL

mm01mm01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN1
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD1
1251617cetylpyridinium chloride 0.05 % MouthwashSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-542-43Cetylpyridinium Chloride473 mL in 1 BOTTLE, PLASTICLIQUID4731

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56062-54256062-542-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
Cetylpyridinium ChlorideCETYLPYRIDINIUM CHLORIDEPublix Super Markets, Inc.4cc128d9-69ab-3f0b-e063-6294a90a6a742026-03-11Warnings, Adverse reactionsExact identifier
ndc (package): 56062-542-43
ndc (product): 56062-542
ndc11 (package): 56062054243
spl id: 4cc128d9-69ac-3f0b-e063-6294a90a6a74
spl set id: 4cc128d9-69ab-3f0b-e063-6294a90a6a74

Reported adverse events (FAERS/openFDA)#

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