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 26 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.69271b7a-18c0-4445-8164-cb1620fb54752025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.40bd7406-7ee6-47fe-8481-0a4c8cefce652025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.43194fe1-87a1-4ffa-ad73-a1dcec91fd632025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.b0b3ab27-704a-44b8-8473-d21ac3359ba12025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.39f64f10-f442-45a9-a060-9f99e78c678d2025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.ed5a294a-fc03-43dd-825d-23a2320609002025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.be558e5b-cf35-4035-a69c-8d66deeac6b22025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.a2591a96-ed66-45b1-abf6-6b26d0bb4f442025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.efe92e48-5086-4b61-a298-0d8ceefe100e2025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.1d6a1182-ab63-460a-ab91-8d4c2ae5d01e2025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.e1db79a4-4a24-4c3f-9ee9-2af3f876ac962025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.d3b6669e-479f-4bc1-b533-5e9a0cc652132025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.e42a22ef-1035-4dd0-94b0-43625542d5842025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.3dca05de-cf63-4ca0-88be-473ea637e6b42025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.d6149dfd-f2a5-4bbd-913c-6a95efe5ffd22025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.c6eda1de-4490-4a28-8a31-cbf3e102e74e2025-01-09WarningsExact identifier
application number: M022
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc4261cd90-5087-44a3-bef9-72d33dbf0dfd2025-01-09WarningsExact identifier
application number: M022
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Ince70240a8-fa9d-4005-a3a0-5cca6188bf612025-01-09WarningsExact identifier
application number: M022
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incfda3d254-e103-4be9-9086-51ad022b2b3f2025-01-09WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalc161da79-9ea5-4c7f-890c-4315129fe5bf2025-01-08WarningsExact 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