FDA.reportPublic FDA data

Parodontax

Manufacturer
Haleon US Holdings LLC
Effective date
2025-05-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:00:42

Label at a glance#

ProductParodontax Active Gum Health Mint
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure12 sections

Indications and uses

gingivitis, an early form of gum disease bleeding gums

Dosage and administration

adults 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

Purpose

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

Useshelps prevent and reduce plaque that leads to

INDICATIONS & USAGE SECTION

  • 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 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 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

OTHER SAFETY INFORMATION

  • this rinse is not intended to replace brushing or flossing
  • may cause staining
  • Do not store above 25°C or 77°F

Inactive ingredients (Mint)

INACTIVE INGREDIENT SECTION

Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Inactive Ingredients (Clear Mint)

INACTIVE INGREDIENT SECTION

Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Additional Information

SPL UNCLASSIFIED SECTION

parodontax

ACTIVE GUMHEALTH

Clinically proven ingredient to protect against gum problems

ALWAYS FOLLOW THE LABEL

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

*Kills plaque bacteria associated with gingivitis in a laboratory test

Distributed by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2025 Haleon or Licensor.

Proudly made in the USA with US & globally sourced ingredients. Active made in India.

BOTTLE
RECYCLE

CAP
CHECK LOCALLY†

†Recycling facilities for this product may not exist in your area. Cap film not recyclable.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW LOOK

HALEON

DENTIST RECOMMENDED

parodontax

CPC ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

ACTIVE GUMHEALTH
DAILY MOUTHWASH

KILLS 99.9% OF & SHIELDS
AGAINST PLAQUEBACTERIA*

MINT

0% ALCOHOL

NET WT 16.9 FL OZ (500 mL)

216843: Front Label

216846: Back Label

parodontax active gum health mouthwash mint 500 mL.jpg
parodontax active gum health mouthwash mint 500 mL.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW LOOK

HALEON

DENTIST RECOMMENDED

parodontax

CPC ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

ACTIVE GUMHEALTH

DAILY MOUTHWASH

KILLS 99.9% OF & SHIELDS
AGAINST PLAQUEBACTERIA*

CLEAR MINT

0% ALCOHOL

DYE FREE

NET WT 16.9 FL OZ (500 mL)

216835: Front Label

216836: Back Label

parodontax active gum health mouthwash clear mint 500 mL.jpg
parodontax active gum health mouthwash clear mint 500 mL.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN5
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD5
1100924cetylpyridinium chloride 0.07 % Oral RinseSY5

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
0135-0650-01ParodontaxActive Gum Health Clear Mint500 mL in 1 BOTTLEMOUTHWASH5005
0135-0651-02ParodontaxActive Gum Health Mint500 mL in 1 BOTTLEMOUTHWASH5005
0135-0651-03ParodontaxActive Gum Health Mint1000 mL in 1 BOTTLEMOUTHWASH10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0650PARODONTAX ACTIVE GUM HEALTH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH PARODONTAX ACTIVE GUM HEALTH CLEAR MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 1 package rows20250510_444f931d-5e38-4cda-97ba-98aa0b5fe4f6.zip
0135-0651PARODONTAX ACTIVE GUM HEALTH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH PARODONTAX ACTIVE GUM HEALTH CLEAR MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 2 package rows20250510_444f931d-5e38-4cda-97ba-98aa0b5fe4f6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0651-02ML - Milliliter0135-06516623f36c-11c6-485a-b381-ccd210fb77c612025-12-16
0135-0650-01ML - Milliliter0135-0650fd1046dc-f709-4046-904e-6612841a4b9512025-12-16

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06510135-0651-02, 0135-0651-03
0135-06500135-0650-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 188LQA7B6G8JGIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
2,3'-IMINODI-BENZOIC ACIDH1C37ZB0P3IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 188LQA7B6G8JGIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
BENZOIC ACID8SKN0B0MIMIACT
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 Active Gum Health Clear MintCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC444f931d-5e38-4cda-97ba-98aa0b5fe4f62025-05-08WarningsExact identifier
ndc (package): 0135-0651-03
ndc (package): 0135-0650-01
ndc (package): 0135-0651-02
ndc (product): 0135-0651
ndc (product): 0135-0650
ndc11 (package): 00135065001
ndc11 (package): 00135065102
ndc11 (package): 00135065103
spl id: 34a4093a-3aa9-3c7b-e063-6294a90a961a
spl set id: 444f931d-5e38-4cda-97ba-98aa0b5fe4f6

Reported adverse events (FAERS/openFDA)#

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