FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
CloSYS Silver Healthy Gums
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.75 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9OM4SK49P

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58578-0407-12024-01-30C16284748780-11030e365-1fc3-111a-e063-dadaa90a10e2CloSYS Healthy Gums Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58578-0407-1CloSYS Silver Healthy Gums1 in 1 CARTONLIQUID15
58578-0407-1CloSYS Silver Healthy Gums946 mL in 1 BOTTLELIQUID9465
58578-0407-2CloSYS Silver Healthy Gums2 in 1 PACKAGELIQUID25
58578-0407-2CloSYS Silver Healthy Gums946 mL in 1 BOTTLELIQUID9465
58578-0407-3CloSYS Silver Healthy Gums3 in 1 PACKAGELIQUID35
58578-0407-3CloSYS Silver Healthy Gums946 mL in 1 BOTTLELIQUID9465
58578-0407-4CloSYS Silver Healthy Gums946 mL in 1 BOTTLELIQUID9465

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58578-0407CLOSYS SILVER HEALTHY GUMS (CETYLPYRIDINIUM CHLORIDE) LIQUID [ROWPAR PHARMACEUTICALS, INC.]4Current NDC, 7 package rows20250523_11fd3f31-ee0c-43d2-a856-929d1298277c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58578-0407-1585780407011 BOTTLE in 1 CARTON (58578-0407-1) / 946 mL in 1 BOTTLE1 bottle2023-03-15NoNoCurrent
58578-0407-2585780407022 BOTTLE in 1 PACKAGE (58578-0407-2) / 946 mL in 1 BOTTLE2 bottle2023-03-15NoNoCurrent
58578-0407-3585780407033 BOTTLE in 1 PACKAGE (58578-0407-3) / 946 mL in 1 BOTTLE3 bottle2023-03-15NoNoCurrent
58578-0407-458578040704946 mL in 1 BOTTLE (58578-0407-4) 946 ml2023-03-15NoNoCurrent