FDA.reportPublic FDA data

TheraBreath Healthy Gums

Product NDC
10237-258
11-digit product format
102370258
Labeler code
10237
Product ID
10237-258_3d3505a3-77e1-1402-e063-6294a90ad2a3
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
2023-02-13
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.01 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 Healthy Gums
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.01 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
e06bfc9e-38e5-475b-89c1-026ccfe56031Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-258-01TheraBreath Healthy Gums1000 mL in 1 BOTTLE, PLASTICRINSE10008
10237-258-03TheraBreath Healthy Gums88.7 mL in 1 BOTTLE, PLASTICRINSE88.78
10237-258-10TheraBreath Healthy Gums296 mL in 1 BOTTLE, PLASTICRINSE2968
10237-258-16TheraBreath Healthy Gums473 mL in 1 BOTTLE, PLASTICRINSE4738
10237-258-21TheraBreath Healthy Gums2 in 1 PACKAGERINSE28
10237-258-21TheraBreath Healthy Gums1000 mL in 1 BOTTLE, PLASTICRINSE10008
10237-258-26TheraBreath Healthy Gums2 in 1 BOXRINSE28
10237-258-26TheraBreath Healthy Gums473 mL in 1 BOTTLE, PLASTICRINSE4738
10237-258-16TheraBreath473 mL in 1 BOTTLE, PLASTICRINSE473 mL0.01 mg in 20mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-258THERABREATH HEALTHY GUMS (CETYLPYRIDINIUM CHLORIDE) RINSE [CHURCH & DWIGHT CO., INC.]7Current NDC, 8 package rows20250223_e06bfc9e-38e5-475b-89c1-026ccfe56031.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 Healthy GumsCETYLPYRIDINIUM CHLORIDEChurch & Dwight Co., Inc.e06bfc9e-38e5-475b-89c1-026ccfe560312025-12-03WarningsExact identifier
ndc (product): 10237-258

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251772cetylpyridinium chloride 0.1 % Mucous Membrane Topical SolutionPSN4b803b5f-0d8c-a3e0-e063-6294a90a2ecf1
1251772cetylpyridinium chloride 1 MG/ML Mucous Membrane Topical SolutionSCD4b803b5f-0d8c-a3e0-e063-6294a90a2ecf1
1251772cetylpyridinium chloride 0.1 % Mucous Membrane Topical SolutionSY4b803b5f-0d8c-a3e0-e063-6294a90a2ecf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-258-01102370258011000 mL in 1 BOTTLE, PLASTIC (10237-258-01) 1000 ml2023-02-13NoNoCurrent
10237-258-031023702580388.7 mL in 1 BOTTLE, PLASTIC (10237-258-03) 88.7 ml2023-02-13NoNoCurrent
10237-258-1010237025810296 mL in 1 BOTTLE, PLASTIC (10237-258-10) 296 ml2025-12-23NoNoCurrent
10237-258-1610237025816473 mL in 1 BOTTLE, PLASTIC (10237-258-16) 473 ml2023-02-13NoNoCurrent
10237-258-21102370258212 BOTTLE, PLASTIC in 1 PACKAGE (10237-258-21) / 1000 mL in 1 BOTTLE, PLASTIC2025-03-31NoNoCurrent
10237-258-26102370258262 BOTTLE, PLASTIC in 1 BOX (10237-258-26) / 473 mL in 1 BOTTLE, PLASTIC2024-02-01NoNoCurrent