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 Identifiers#

Field, Values table
FieldValues
Rxcui1251772

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

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