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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D9OM4SK49PInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11fd3f31-ee0c-43d2-a856-929d1298277cAvailable on FDA.report

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

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 1 of 42 · 823 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEHarris Teeter, LLC7e5f175d-f0d6-4665-ac14-1873d6b99c802026-08-12WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)584b38ce-d1ef-4ecc-a887-7c96e7f9669f2026-08-12WarningsExact identifier
application number: M022
Gingicaine Gel Variety PakGINGICAINE GEL VARIETY PAKGingi-Pak a Division of the Belport62ed4ff3-18f6-5c67-e053-2991aa0a77922026-08-11WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsExact identifier
application number: M022
Ollie Fresh MintSODIUM FLUORIDE, POTASSIUM NITRATEBrio Product Group LLC.ebeec44f-3c22-43f2-9256-6ece6025c1052026-08-06WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.5868c5a1-273f-f023-e063-6394a90ac9d82026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58690bb5-9604-26a4-e063-6394a90afdbe2026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586918cf-7b13-5999-e063-6294a90a88a92026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586924a0-322d-5dc3-e063-6294a90a15562026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58692e90-de74-52d3-e063-6394a90a97022026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586937ae-46af-7066-e063-6294a90ae53e2026-08-06WarningsExact identifier
application number: M022
Freshness Blueberry Toothpaste100gFRESHNESS BLUEBERRY TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d1dba-87fc-b676-e063-6294a90a14702026-08-06WarningsExact identifier
application number: M022
Freshness Coffee Toothpaste100gFRESHNESS COFFEE TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d79e9-2f0f-fa72-e063-6394a90a8dea2026-08-06WarningsExact identifier
application number: M022
Freshness Flower Rose Toothpaste100gFRESHNESS FLOWER ROSE TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d7f5e-55e0-4fd2-e063-6294a90a92b62026-08-06WarningsExact identifier
application number: M022
PRO-SYSORAL WOUND CLEANSERForward Science Technologies LLCc357c8f8-6fd6-c2f8-e053-2995a90a40232026-07-30WarningsExact identifier
application number: M022
Lornamead Natural WhiteFLUORIDELornamead Products9d7d08d7-8ca4-4b05-8b74-3bfa372b16082026-07-29WarningsExact identifier
application number: M022
Made by Dentists Enamel 10 Fluoride AnticavityPOTASSIUM NITRATE, SODIUM FLUORIDEMade By Dentists Inc3c62eab1-0cb6-4bdf-bfd4-c5afe734d0362026-07-24WarningsExact identifier
application number: M022
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
application number: M022
Good Neighbor Sore Throat Cherry FlavorPHENOLAMERISOURCE BERGENaa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f2026-07-13WarningsExact identifier
application number: M022

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