FDA.reportPublic FDA data

Oral-B

Product NDC
0041-1420
11-digit product format
000411420
Labeler code
0041
Product ID
0041-1420_fdb37c8d-9768-4e34-a17a-27124a0895ca
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
LIQUID
Route
DENTAL
Labeler
Oral-B Laboratories
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-10-15
Marketing end
0000-00-00
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
500 ug/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0041-1420IInactivated by FDA2026-07-31
excluded packagepackage0041-14200041-1420-16IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inc.689349e4-3980-a0e4-e053-2991aa0a9ef52018-03-29WarningsExact identifier
ENT Essentials Ear Wax RemvoerCARBAMIDE PEROXIDEWisconsin Pharmacal Company5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b12017-11-08WarningsExact identifier
Dental ReliefBENZOCAINECintas First Aid & Safetyd9068a54-6123-4715-b025-a5bdb4d5c7022014-02-27WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings When using this product do not use longer than four weeks unless recommended by a dentist

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0041-1420-162019-10-21C16284748780-1956f9ecf-c180-621f-e053-dbdaa90a74adOral -B® Anti-Bacterial Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0041-1420-16Oral-BAnti-Bacterial500 mL in 1 BOTTLE, PLASTICLIQUID5001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetylpyridinium ChlorideACTIVE INGREDIENTD9OM4SK49PORAL-B ANTI-BACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [ORAL-B LABORATORIES]1
CetylpyridiniumACTIVE MOIETYCUB7JI0JV3ORAL-B ANTI-BACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [ORAL-B LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0041-1420ORAL-B ANTI-BACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [ORAL-B LABORATORIES]1Legacy NDC, 1 package rows20100420_89bfbf53-8da7-4d88-b051-aa6789a0eaec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN89bfbf53-8da7-4d88-b051-aa6789a0eaec1
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD89bfbf53-8da7-4d88-b051-aa6789a0eaec1
1251617cetylpyridinium chloride 0.05 % MouthwashSY89bfbf53-8da7-4d88-b051-aa6789a0eaec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0041-1420-1600041142016500 mL in 1 BOTTLE, PLASTIC500 mlHistorical