FDA.reportPublic FDA data

Oral B Plaque Defense

Product NDC
69423-855
11-digit product format
694230855
Labeler code
69423
Product ID
69423-855_47e46668-d67a-0d37-e063-6394a90a7dc4
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium chloride
Dosage form
RINSE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-01
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.07 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
Oral B Plaque Defense
Brand name suffix
Special Care Oral Rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.07 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1100924Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d503fad5-a378-0e60-e053-2a95a90abe65Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-855-16Oral B Plaque DefenseSpecial Care Oral Rinse475 mL in 1 BOTTLE, PLASTICRINSE4759

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-855ORAL B PLAQUE DEFENSE SPECIAL CARE ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) RINSE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]7Current NDC, Legacy NDC, 1 package rows20250207_d503fad5-a378-0e60-e053-2a95a90abe65.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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Gum Therapy Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCed6889b6-58db-41cf-e053-2a95a90a7de22024-11-11WarningsExact identifier
application number: M022
Listerine FreshBurst AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC62b5c3ee-01cc-4c4e-9f28-e7dafa7372d82024-11-11WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLCdd3729c2-fd05-4db0-a542-487bb0f9001f2024-11-11WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC9e97e4f8-80c2-44e0-862c-0dfca392a4362024-11-11WarningsExact identifier
application number: M022
Orajel 2X Medicated GelORAL PAIN RELIEVERChurch & Dwight Co., Inc.262be295-4eaf-3136-e063-6294a90a7dcc2024-11-05WarningsExact identifier
application number: M022
BIOTENE Fresh Mint OriginalSODIUM FLUORIDEHaleon US Holdings LLC1101c17f-c848-4cd5-a7cd-679b59dbe1bf2024-11-05WarningsExact identifier
application number: M022
bioteneSODIUM MONOFLUOROPHOSPHATEHaleon US Holdings LLCa47a6502-efb2-4072-9562-cbe293531c2b2024-11-04WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser CherrySODIUM PERBORATE MONOHYDRATEVintage Brands Limiteda0e145c8-6b08-40be-ae4f-5678c4a78b1e2024-10-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33b-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33a-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043a3cb4-f560-0ffd-e063-6394a90a2ff62024-10-29WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser MintSODIUM PERBORATE MONOHYDRATEVintage Brands Limitedbe57ca56-834f-4170-a407-f193484d8b0a2024-10-29WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean MintSODIUM FLUORIDEHaleon US Holdings LLC817c0dad-d109-428e-adb5-3354604acc942024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC1f3d68f6-afd6-42e7-b3e5-210228c8e7de2024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC0dd15227-6603-42ac-9a5f-f2dc49e0382a2024-10-28Warnings, Adverse reactionsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0605d5d6-82bd-415e-b5cb-e273f934a4a72024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCf70fa3fc-cd65-4a80-9efd-129e98fd39982024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief MentholPHENOLChain Drug Consortiumaf661ef0-cdc3-4146-8ae5-59795aa496502024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLChain Drug Consortiuma9cf9829-4b70-44fa-9719-240b65c067242024-10-28WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEPHARMACY VALUE ALLIANCE, LLC85ae80c1-2bc2-4c90-9559-63510d03e7392024-10-28WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSNd503fad5-a378-0e60-e053-2a95a90abe659
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCDd503fad5-a378-0e60-e053-2a95a90abe659
1100924cetylpyridinium chloride 0.07 % Oral RinseSYd503fad5-a378-0e60-e053-2a95a90abe659

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-855-1669423085516475 mL in 1 BOTTLE, PLASTIC (69423-855-16) 475 ml2022-01-010000-00-00NoNoCurrent