Home NDC 59450-997-86 Antigingivitis/Antiplaque
Product NDC 59450-997
Requested package NDC 59450-997-86
11-digit product format 594500997
Labeler code 59450
Product ID 59450-997_4bd21344-e34f-9f71-e063-6294a90aec5b
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium Chloride
Dosage form MOUTHWASH
Route ORAL
Labeler The Kroger Co.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-22
Substance CETYLPYRIDINIUM CHLORIDE
Active strength .7 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 .7 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 1100924 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 59450-997-86 Antigingivitis/Antiplaque 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59450-997 ANTIGINGIVITIS/ANTIPLAQUE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [THE KROGER CO] 3 Current NDC, Legacy NDC, 1 package rows 20240913_922bff32-7536-4a6d-b04b-0b02f14fbecc.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 Marketing end Sample Exclude flag Status 59450-997-86 59450099786 1000 mL in 1 BOTTLE, PLASTIC (59450-997-86) 1000 ml 2022-09-22 0000-00-00 No No Current