Home NDC 53462-175 Antiseptic Oral Rinse
Product NDC 53462-175
11-digit product format 534620175
Labeler code 53462
Product ID 53462-175_55068435-9db1-0599-e063-6294a90abea5
Type HUMAN OTC DRUG
Nonproprietary name CETYLPYRIDINIUM CHLORIDE
Dosage form MOUTHWASH
Route BUCCAL
Labeler Sage Products LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2000-06-21
Substance CETYLPYRIDINIUM CHLORIDE
Active strength .5 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 Antiseptic Oral Rinse
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53462-175-60 Antiseptic Oral Rinse 7 mL in 1 PACKET MOUTHWASH 7 11 53462-175-60 QCare Petite Size Oral Cleansing and Suctioning System 7 mL in 1 PACKET MOUTHWASH 42 mL in 6 0.5 mg in 1mL 4 53462-175-60 Suction Toothbrushes 7 mL in 1 PACKET MOUTHWASH 7 mL 0.5 mg in 1mL 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53462-175 ANTISEPTIC ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [SAGE PRODUCTS LLC] 9 Current NDC, Legacy NDC, 1 package rows 20241120_efff8bae-154d-46bc-8dd4-716800425663.zip 53462-175 QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS, LLC] 4 Current NDC, Legacy NDC 20190118_b08bc4f9-85db-b57c-5e1d-97e3383acf18.zip 53462-175 SUCTION TOOTHBRUSHES (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC] 3 Current NDC, Legacy NDC 20180426_9f81731e-6343-49e0-a2b4-e8269d6bcd6a.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 14 of 40 · 786 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 53462-175-60 53462017560 7 mL in 1 PACKET (53462-175-60) 7 ml 2001-12-28 0000-00-00 No No Current