FDA.reportPublic FDA data

Parodontax

Product NDC
0135-0651
11-digit product format
001350651
Labeler code
0135
Product ID
0135-0651_34a4093a-3aa9-3c7b-e063-6294a90a961a
Type
HUMAN OTC DRUG
Nonproprietary name
cetylpyridinium chloride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-03
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
70 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

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

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Stop use and ask a dentist if 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. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Parodontax
Brand name suffix
Active Gum Health Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE70 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9OM4SK49P
Rxcui1100924

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

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard 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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN444f931d-5e38-4cda-97ba-98aa0b5fe4f65
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD444f931d-5e38-4cda-97ba-98aa0b5fe4f65
1100924cetylpyridinium chloride 0.07 % Oral RinseSY444f931d-5e38-4cda-97ba-98aa0b5fe4f65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0651-0200135065102500 mL in 1 BOTTLE (0135-0651-02) 500 ml2022-01-030000-00-00NoNoCurrent
0135-0651-03001350651031000 mL in 1 BOTTLE (0135-0651-03) 1000 ml2022-10-030000-00-00NoNoCurrent