Home NDC 53329-030 DuoCare Clinical Oral Rinse
Product NDC 53329-030
11-digit product format 533290030
Labeler code 53329
Product ID 53329-030_40d1c70d-8f8c-2334-e063-6394a90a4d35
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium Chloride
Dosage form MOUTHWASH
Route DENTAL
Labeler Medline Industries, LP
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-11-01
Substance CETYLPYRIDINIUM CHLORIDE
Active strength 1 mg/mL
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 DuoCare Clinical Oral Rinse
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE 1 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1291375 Internal RxNorm lookup 2264796 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 53329-030-07 DuoCare Clinical Oral Rinse 7 mL in 1 POUCH MOUTHWASH 7 8 53329-030-13 DuoCare Clinical Oral Rinse 59 mL in 1 BOTTLE MOUTHWASH 59 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-030 DUOCARE CLINICAL ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MEDLINE INDUSTRIES, LP] 8 Current NDC, Legacy NDC, 2 package rows 20231017_98e61cd5-7e29-7066-e053-2a95a90afa21.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 9 of 41 · 818 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 53329-030-07 53329003007 7 mL in 1 POUCH (53329-030-07) 7 ml 2018-11-01 0000-00-00 No No Current 53329-030-13 53329003013 59 mL in 1 BOTTLE (53329-030-13) 59 ml 2018-11-01 0000-00-00 No No Current