Home NDC 10237-258-16 TheraBreath Healthy Gums
Product NDC 10237-258
Requested package NDC 10237-258-16
11-digit product format 102370258
Labeler code 10237
Product ID 10237-258_5c2b4603-5f51-e56b-e063-6394a90a705b
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 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TheraBreath Healthy Gums
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE .01 mg/20mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10237-258-01 TheraBreath Healthy Gums 1000 mL in 1 BOTTLE, PLASTIC RINSE 1000 8 10237-258-03 TheraBreath Healthy Gums 88.7 mL in 1 BOTTLE, PLASTIC RINSE 88.7 8 10237-258-10 TheraBreath Healthy Gums 296 mL in 1 BOTTLE, PLASTIC RINSE 296 8 10237-258-16 TheraBreath Healthy Gums 473 mL in 1 BOTTLE, PLASTIC RINSE 473 8 10237-258-21 TheraBreath Healthy Gums 2 in 1 PACKAGE RINSE 2 8 10237-258-21 TheraBreath Healthy Gums 1000 mL in 1 BOTTLE, PLASTIC RINSE 1000 8 10237-258-26 TheraBreath Healthy Gums 2 in 1 BOX RINSE 2 8 10237-258-26 TheraBreath Healthy Gums 473 mL in 1 BOTTLE, PLASTIC RINSE 473 8 10237-258-16 TheraBreath 473 mL in 1 BOTTLE, PLASTIC RINSE 473 mL 0.01 mg in 20mL 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-258 THERABREATH HEALTHY GUMS (CETYLPYRIDINIUM CHLORIDE) RINSE [CHURCH & DWIGHT CO., INC.] 7 Current NDC, 8 package rows 20250223_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10237-258-16 10237025816 473 mL in 1 BOTTLE, PLASTIC (10237-258-16) 473 ml 2023-02-13 No No Current