Home NDC 10237-261-16 Therabreath Deep Clean Fresh Mint
Product NDC 10237-261
Requested package NDC 10237-261-16
11-digit product format 102370261
Labeler code 10237
Product ID 10237-261_453a6780-e9fb-e694-e063-6294a90a2122
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 2023-06-30
Substance CETYLPYRIDINIUM CHLORIDE
Active strength 20 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 Deep Clean Fresh Mint
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE 20 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D9OM4SK49P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1251772 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10237-261-01 Therabreath Deep Clean Fresh Mint 1000 mL in 1 BOTTLE, PLASTIC RINSE 1000 3 10237-261-03 Therabreath Deep Clean Fresh Mint 88.7 mL in 1 BOTTLE, PLASTIC RINSE 88.7 3 10237-261-16 Therabreath Deep Clean Fresh Mint 473 mL in 1 BOTTLE, PLASTIC RINSE 473 3 10237-261-26 Therabreath Deep Clean Fresh Mint 2 in 1 PACKAGE RINSE 2 3 10237-261-26 Therabreath Deep Clean Fresh Mint 473 mL in 1 BOTTLE, PLASTIC RINSE 473 3 10237-261-16 TheraBreath 473 mL in 1 BOTTLE, PLASTIC RINSE 473 mL 20 mg in 20mL 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-261 THERABREATH DEEP CLEAN FRESH MINT (CETYLPYRIDINIUM CHLORIDE) RINSE [CHURCH & DWIGHT CO., INC.] 2 Current NDC, 5 package rows 20240815_19bb1bc2-f4e3-4faa-82a5-656fec4397dd.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 · 2 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 10237-261-16 10237026116 473 mL in 1 BOTTLE, PLASTIC (10237-261-16) 473 ml 2024-02-15 No No Current