FDA.reportPublic FDA data

Parodontax

Manufacturer
Haleon US Holdings LLC
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:13

Label at a glance#

ProductParodontax Gum Strengthen and Protect
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Indications and uses

helps prevent and reduce plaque that leads to gingivitis, an early form of gum disease bleeding gums

Dosage and administration

adult and children 6 years of age and older: measure twice up to 10 milliliters mark inside of cap. Vigorously swish 20 milliliters of the rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. Do not rinse with water. Do not drink from the bottle. children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.07% w/w

Purposes

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

Uses

INDICATIONS & USAGE SECTION

helps prevent and reduce plaque that leads to

  • gingivitis, an early form of gum disease
  • bleeding gums

Warnings

WARNINGS SECTION

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • irritation occurs
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space 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

  • adult and children 6 years of age and older:measure twice up to 10 milliliters mark inside of cap. Vigorously swish 20 milliliters of the rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. Do not rinse with water. Do not drink from the bottle.
  • children 6 years to under 12 years of age:supervise use
  • children under 6 years of age:do not use

Other information

SPL UNCLASSIFIED SECTION

  • this rinse is not intended to replace brushing or flossing
  • may cause staining
  • do not store above 25°C (77°F)
  • this product may turn cloudy. Its antimicrobial properties are not affected.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, propylene glycol, poloxamer 407, flavor, benzoic acid, sodium benzoate, sodium saccharin, sucralose, sodium hyaluronate, blue 1

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Additional Information

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

Do not use if printed safety seal around cap is broken or missing.

*With continued twice daily use

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DENTIST RECOMMENDED

parodontax

CPC ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

GUM STRENGTHEN & PROTECT

with HYALURONIC ACIDfor extra freshness

HELPS STRENGTHEN THE GUM SEAL AROUND TEETH FOR LONG-LASTING GUM PROTECTION*

ICY MINT

0% ALCOHOL

NET WT 16.9 FL OZ (500 mL)

Parodontax Gum Strengthen and Protect Mouthwash 500 mL
Parodontax Gum Strengthen and Protect Mouthwash 500 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN2
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD2
1100924cetylpyridinium chloride 0.07 % Oral RinseSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0022353FAParodontax Gum Strengthen and Protect Mouthwash 500 mL.jpg

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
0135-0654-01ParodontaxGum Strengthen and Protect500 mL in 1 BOTTLERINSE5002
0135-0654-02ParodontaxGum Strengthen and Protect1000 mL in 1 BOTTLERINSE10002

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06540135-0654-01, 0135-0654-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLOXAMER 407TUF2IVW3M2IACT
BENZOIC ACID8SKN0B0MIMIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
BASIC BLUE 192N74OA24DIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB

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
Parodontax Gum Strengthen and ProtectCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC3bb378c8-14b2-aa13-e063-6294a90a4db32026-01-05WarningsExact identifier
ndc (package): 0135-0654-01
ndc (package): 0135-0654-02
ndc (product): 0135-0654
ndc11 (package): 00135065402
ndc11 (package): 00135065401
spl id: 42f43384-3141-36ff-e063-6294a90a5412
spl set id: 3bb378c8-14b2-aa13-e063-6294a90a4db3

Reported adverse events (FAERS/openFDA)#

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