Home NDC 76162-953 Antigingivitis/Antiplaque
Product NDC 76162-953
11-digit product format 761620953
Labeler code 76162
Product ID 76162-953_4aba1791-ba47-f1f3-e063-6394a90a55f2
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium Chloride
Dosage form MOUTHWASH
Route ORAL
Labeler Topco Associates LLC
Application M505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-18
Substance CETYLPYRIDINIUM CHLORIDE
Active strength .5 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Antigingivitis/Antiplaque
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE .5 mg/mL
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 1251617 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76162-953-86 Antigingivitis/Antiplaque 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-953 ANTIGINGIVITIS/ANTIPLAQUE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC] 2 Current NDC, 1 package rows 20250425_3fefe9b3-d61d-494d-bd85-5d2cf8321398.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 76162-953-86 76162095386 1000 mL in 1 BOTTLE, PLASTIC (76162-953-86) 1000 ml 2024-04-18 No No Current