Home NDC 84516-040 Cloveden 100 times higher concentrated
Product NDC 84516-040
11-digit product format 845160040
Labeler code 84516
Product ID 84516-040_3c0e1862-2940-4d23-e063-6294a90a33e1
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium Chloride
Dosage form MOUTHWASH
Route ORAL
Labeler Acuseplanet Inc
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-01
Substance CETYLPYRIDINIUM CHLORIDE
Active strength 2.29 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Cloveden 100 times higher concentrated
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE 2.29 g/100mL
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 2590919 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 84516-040-01 Cloveden 100 times higher concentrated 50 mL in 1 BOTTLE MOUTHWASH 50 1 84516-040-02 Cloveden 100 times higher concentrated 1 in 1 CARTON MOUTHWASH 1 1
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 45 of 50 · 995 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 84516-040-01 84516004001 50 mL in 1 BOTTLE 50 ml Historical 84516-040-02 84516004002 1 BOTTLE in 1 CARTON (84516-040-02) / 50 mL in 1 BOTTLE (84516-040-01) 1 bottle 2025-08-01 No No Current