Home NDC 53462-275 Antiplaque solution
Product NDC 53462-275
11-digit product format 534620275
Labeler code 53462
Product ID 53462-275_5568ec99-5769-624a-e063-6294a90a7149
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 2009-01-09
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 Antiplaque solution
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 53462-275-60 Antiplaque solution 7 mL in 1 PACKET MOUTHWASH 7 13 53462-275-60 QCare Oral Cleansing and Suctioning System, Q8 7 mL in 1 PACKET MOUTHWASH 14 mL 0.5 mg in 1mL 11 53462-275-60 QCare Oral Cleansing and Suctioning System, Q4 7 mL in 1 PACKET MOUTHWASH 14 mL 0.5 mg in 1mL 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded cetylpyridinium chloride ACTIVE INGREDIENT D9OM4SK49P CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] 1 CETYLPYRIDINIUM CHLORIDE ACTIVE INGREDIENT D9OM4SK49P QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 HYDROGEN PEROXIDE ACTIVE INGREDIENT BBX060AN9V QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 cetylpyridinium ACTIVE MOIETY CUB7JI0JV3 CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] 1 CETYLPYRIDINIUM ACTIVE MOIETY CUB7JI0JV3 QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 HYDROGEN PEROXIDE ACTIVE MOIETY BBX060AN9V QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 peppermint INACTIVE INGREDIENT V95R5KMY2B CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] 1 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 potassium sorbate INACTIVE INGREDIENT 1VPU26JZZ4 CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 sorbitol INACTIVE INGREDIENT 506T60A25R CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 1 water INACTIVE INGREDIENT 059QF0KO0R CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53462-275 ANTIPLAQUE SOLUTION (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [SAGE PRODUCTS LLC] 11 Current NDC, Legacy NDC, 1 package rows 20241116_881d4d08-4b45-486a-93af-18c0e00a5b0e.zip 53462-275 QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q8 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC] 11 Current NDC, Legacy NDC 20220223_f30104fd-7f9a-4db1-8006-36b5b6d7ddae.zip 53462-275 QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] 7 Current NDC, Legacy NDC 20180629_567bf599-4958-91c7-5c01-9c38a0d2da52.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 32 of 40 · 782 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 53462-275-60 53462027560 7 mL in 1 PACKET (53462-275-60) 7 ml 2009-01-09 0000-00-00 No No Current