FDA.reportPublic FDA data

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
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.5 mg/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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1251617Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
881d4d08-4b45-486a-93af-18c0e00a5b0eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-02-22Antiplaque Solution
2022-02-22Antiplaque Solution
2022-02-22Antiplaque Solution
2022-01-28Antiplaque Solution
2022-01-28Antiplaque Solution
2022-01-28Antiplaque Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-275-60Antiplaque solution7 mL in 1 PACKETMOUTHWASH713
53462-275-60QCare Oral Cleansing and Suctioning System, Q87 mL in 1 PACKETMOUTHWASH14 mL0.5 mg in 1mL11
53462-275-60QCare Oral Cleansing and Suctioning System, Q47 mL in 1 PACKETMOUTHWASH14 mL0.5 mg in 1mL7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cetylpyridinium chlorideACTIVE INGREDIENTD9OM4SK49PCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]1
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PQCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
HYDROGEN PEROXIDEACTIVE INGREDIENTBBX060AN9VQCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
cetylpyridiniumACTIVE MOIETYCUB7JI0JV3CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]1
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VQCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPQCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDQCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BQCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
peppermintINACTIVE INGREDIENTV95R5KMY2BCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNQCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHQCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HQCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYQCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RQCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
sorbitolINACTIVE INGREDIENT506T60A25RCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RQCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]1
waterINACTIVE INGREDIENT059QF0KO0RCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-275ANTIPLAQUE SOLUTION (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [SAGE PRODUCTS LLC]11Current NDC, Legacy NDC, 1 package rows20241116_881d4d08-4b45-486a-93af-18c0e00a5b0e.zip
53462-275QCARE 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]11Current NDC, Legacy NDC20220223_f30104fd-7f9a-4db1-8006-36b5b6d7ddae.zip
53462-275QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]7Current NDC, Legacy NDC20180629_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 39 of 39 · 779 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AvantBENZOCAINEDharma Research, Inc.fc8194af-2e77-4ad1-ae75-461dce3ed6042023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.baf7d184-07ed-4491-a1fc-9a377b4b01102023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.033034af-c86c-4dbf-90eb-009c117024c62023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.658ada18-2334-4b4e-b08e-702fa127aa142023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.cad932e5-8d7f-4f20-b1c2-febd328152f02023-10-11WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.2c9519ab-320d-49da-9deb-97a6168fb0882023-10-10WarningsExact identifier
application number: M022
IolineBENZOCAINEDharma Research, Inc.b862c974-c024-42c3-986e-b65069437c7b2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.651ea978-081d-4c59-b177-6049a69d94152023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.db763237-2910-45b9-be72-da092edc951b2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.34316f93-10b4-41cc-8654-625283f0044c2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.142a8824-657e-492a-8e5a-b15eb73383c92023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.414cbec9-94e2-4bca-908b-1e79f8db0b272023-10-10WarningsExact identifier
application number: M022
Sore throat cherryPHENOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)de634cf1-ed39-4d8a-8855-006c69b7aee92023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN881d4d08-4b45-486a-93af-18c0e00a5b0e13
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD881d4d08-4b45-486a-93af-18c0e00a5b0e13
1251617cetylpyridinium chloride 0.05 % MouthwashSY881d4d08-4b45-486a-93af-18c0e00a5b0e13
1251617cetylpyridinium chloride 0.05 % MouthwashPSNf30104fd-7f9a-4db1-8006-36b5b6d7ddae11
358975hydrogen peroxide 1.5 % MouthwashPSNf30104fd-7f9a-4db1-8006-36b5b6d7ddae11
1866540Perox-A-Mint 1.5 % MouthwashPSNf30104fd-7f9a-4db1-8006-36b5b6d7ddae11
1866540hydrogen peroxide 15 MG/ML Mouthwash [Perox-A-Mint]SBDf30104fd-7f9a-4db1-8006-36b5b6d7ddae11
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCDf30104fd-7f9a-4db1-8006-36b5b6d7ddae11
358975hydrogen peroxide 15 MG/ML MouthwashSCDf30104fd-7f9a-4db1-8006-36b5b6d7ddae11
1251617cetylpyridinium chloride 0.05 % MouthwashSYf30104fd-7f9a-4db1-8006-36b5b6d7ddae11
358975hydrogen peroxide 1.5 % MouthwashSYf30104fd-7f9a-4db1-8006-36b5b6d7ddae11
1866540Perox-A-Mint 1.5 % MouthwashSYf30104fd-7f9a-4db1-8006-36b5b6d7ddae11
1866540Perox-A-Mint 15 MG/ML MouthwashSYf30104fd-7f9a-4db1-8006-36b5b6d7ddae11
1251617cetylpyridinium chloride 0.05 % MouthwashPSN567bf599-4958-91c7-5c01-9c38a0d2da527
358975hydrogen peroxide 1.5 % MouthwashPSN567bf599-4958-91c7-5c01-9c38a0d2da527
1866540Perox-A-Mint 1.5 % MouthwashPSN567bf599-4958-91c7-5c01-9c38a0d2da527
1866540hydrogen peroxide 15 MG/ML Mouthwash [Perox-A-Mint]SBD567bf599-4958-91c7-5c01-9c38a0d2da527
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD567bf599-4958-91c7-5c01-9c38a0d2da527
358975hydrogen peroxide 15 MG/ML MouthwashSCD567bf599-4958-91c7-5c01-9c38a0d2da527
1251617cetylpyridinium chloride 0.05 % MouthwashSY567bf599-4958-91c7-5c01-9c38a0d2da527
358975hydrogen peroxide 1.5 % MouthwashSY567bf599-4958-91c7-5c01-9c38a0d2da527
1866540Perox-A-Mint 1.5 % MouthwashSY567bf599-4958-91c7-5c01-9c38a0d2da527
1866540Perox-A-Mint 15 MG/ML MouthwashSY567bf599-4958-91c7-5c01-9c38a0d2da527

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53462-275-60534620275607 mL in 1 PACKET (53462-275-60) 7 ml2009-01-090000-00-00NoNoCurrent