TheraBreath

Product NDC
10237-269
11-digit product format
102370269
Labeler code
10237
Product ID
10237-269_4b803b5f-0d8d-a3e0-e063-6294a90a2ecf
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium chloride
Dosage form
KIT
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TheraBreath
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1251772Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b803b5f-0d8c-a3e0-e063-6294a90a2ecfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-258-16TheraBreath473 mL in 1 BOTTLE, PLASTICRINSE473 mL0.01 mg in 20mL1
10237-261-16TheraBreath473 mL in 1 BOTTLE, PLASTICRINSE473 mL20 mg in 20mL1
10237-269-01TheraBreath1 in 1 CARTONKIT11

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
TheraBreathCETYLPYRIDINIUM CHLORIDEChurch & Dwight Co., Inc.4b803b5f-0d8c-a3e0-e063-6294a90a2ecf2026-01-01WarningsExact identifier
ndc (product): 10237-269

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
10237-258-1610237025816473 mL in 1 BOTTLE, PLASTIC473 mlHistorical
10237-261-1610237026116473 mL in 1 BOTTLE, PLASTIC473 mlHistorical
10237-269-01102370269011 KIT in 1 CARTON (10237-269-01) * 473 mL in 1 BOTTLE, PLASTIC (10237-261-16) * 473 mL in 1 BOTTLE, PLASTIC (10237-258-16) 1 kit2026-01-01NoNoCurrent