FDA.reportPublic FDA data

Parodontax

Product NDC
0135-0654
11-digit product format
001350654
Labeler code
0135
Product ID
0135-0654_42f43384-3141-36ff-e063-6294a90a5412
Type
HUMAN OTC DRUG
Nonproprietary name
cetylpyridinium chloride
Dosage form
RINSE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-05
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.7 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 Gum Strengthen and ProtectCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC3bb378c8-14b2-aa13-e063-6294a90a4db32026-01-05WarningsExact 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 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. 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
Gum Strengthen and Protect
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.7 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
0135-0654-01ParodontaxGum Strengthen and Protect500 mL in 1 BOTTLERINSE5002
0135-0654-02ParodontaxGum Strengthen and Protect1000 mL in 1 BOTTLERINSE10002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN3bb378c8-14b2-aa13-e063-6294a90a4db32
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD3bb378c8-14b2-aa13-e063-6294a90a4db32
1100924cetylpyridinium chloride 0.07 % Oral RinseSY3bb378c8-14b2-aa13-e063-6294a90a4db32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-0654-0100135065401500 mL in 1 BOTTLE (0135-0654-01) 500 ml2026-01-05NoNoCurrent
0135-0654-02001350654021000 mL in 1 BOTTLE (0135-0654-02) 1000 ml2026-01-05NoNoCurrent