Home NDC 58578-0407 CloSYS Silver Healthy Gums
Product NDC 58578-0407
11-digit product format 585780407
Labeler code 58578
Product ID 58578-0407_452e539e-8d6e-4150-832b-c8f6760086eb
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium Chloride
Dosage form LIQUID
Route ORAL
Labeler Rowpar Pharmaceuticals, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-15
Substance CETYLPYRIDINIUM CHLORIDE
Active strength .75 g/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 CloSYS Silver Healthy Gums
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE .75 g/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 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 58578-0407-1 CloSYS Silver Healthy Gums 1 in 1 CARTON LIQUID 1 5 58578-0407-1 CloSYS Silver Healthy Gums 946 mL in 1 BOTTLE LIQUID 946 5 58578-0407-2 CloSYS Silver Healthy Gums 2 in 1 PACKAGE LIQUID 2 5 58578-0407-2 CloSYS Silver Healthy Gums 946 mL in 1 BOTTLE LIQUID 946 5 58578-0407-3 CloSYS Silver Healthy Gums 3 in 1 PACKAGE LIQUID 3 5 58578-0407-3 CloSYS Silver Healthy Gums 946 mL in 1 BOTTLE LIQUID 946 5 58578-0407-4 CloSYS Silver Healthy Gums 946 mL in 1 BOTTLE LIQUID 946 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58578-0407 CLOSYS SILVER HEALTHY GUMS (CETYLPYRIDINIUM CHLORIDE) LIQUID [ROWPAR PHARMACEUTICALS, INC.] 4 Current NDC, 7 package rows 20250523_11fd3f31-ee0c-43d2-a856-929d1298277c.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 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58578-0407-1 58578040701 1 BOTTLE in 1 CARTON (58578-0407-1) / 946 mL in 1 BOTTLE 1 bottle 2023-03-15 No No Current 58578-0407-2 58578040702 2 BOTTLE in 1 PACKAGE (58578-0407-2) / 946 mL in 1 BOTTLE 2 bottle 2023-03-15 No No Current 58578-0407-3 58578040703 3 BOTTLE in 1 PACKAGE (58578-0407-3) / 946 mL in 1 BOTTLE 3 bottle 2023-03-15 No No Current 58578-0407-4 58578040704 946 mL in 1 BOTTLE (58578-0407-4) 946 ml 2023-03-15 No No Current