Therabreath Plaque Control

Product NDC
10237-259
11-digit product format
102370259
Labeler code
10237
Product ID
10237-259_45b3634b-1017-96be-e063-6294a90aaa8c
Type
HUMAN OTC DRUG
Nonproprietary name
CETYLPYRIDINIUM CHLORIDE
Dosage form
RINSE
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-25
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.015 mg/20mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Therabreath Plaque Control
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.015 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D9OM4SK49PInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4987c71b-334d-4b20-bab4-b857e08a7383Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-259-16Therabreath Plaque Control473 mL in 1 BOTTLE, PLASTICRINSE4734
10237-259-26Therabreath Plaque Control473 mL in 1 BOTTLE, PLASTICRINSE4734
10237-259-26Therabreath Plaque Control2 in 1 BOXRINSE24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-259THERABREATH PLAQUE CONTROL (CETYLPYRIDINIUM CHLORIDE) RINSE [CHURCH & DWIGHT CO., INC.]3Current NDC, 3 package rows20250221_4987c71b-334d-4b20-bab4-b857e08a7383.zip

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
Therabreath Plaque ControlCETYLPYRIDINIUM CHLORIDEChurch & Dwight Co., Inc.4987c71b-334d-4b20-bab4-b857e08a73832025-12-11WarningsExact identifier
ndc (product): 10237-259

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-259-1610237025916473 mL in 1 BOTTLE, PLASTIC (10237-259-16) 473 ml2023-04-25NoNoCurrent
10237-259-26102370259262 BOTTLE, PLASTIC in 1 BOX (10237-259-26) / 473 mL in 1 BOTTLE, PLASTIC2025-01-01NoNoCurrent