FDA.reportPublic FDA data

Crest Pro Health

Product NDC
67751-186
11-digit product format
677510186
Labeler code
67751
Product ID
67751-186_23862cf2-3da1-b081-e063-6394a90a0386
Type
HUMAN OTC DRUG
Nonproprietary name
CETYLPYRIDINIUM CHLORIDE
Dosage form
RINSE
Route
TOPICAL
Labeler
Navajo Manufacturing Company Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-04
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.014 g/20mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Crest Pro Health
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.014 g/20mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1100924Internal RxNorm lookup
1251371Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65bf17a9-21ad-27cb-e053-2991aa0afc40Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-186-012023-03-15C16284748780-1f386c649-f730-0266-e053-dadaa90a7c1aCrest Pro Health
67751-186-012023-01-30C16284748780-1f386c649-f730-0266-e053-dadaa90a7c1aCrest Pro Health

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-186-01Crest Pro Health36 mL in 1 BOTTLE, PLASTICRINSE364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-186CREST PRO HEALTH (CETYLPYRIDINIUM CHLORIDE) RINSE [NAVAJO MANUFACTURING COMPANY INC.]4Current NDC, Legacy NDC, 1 package rows20241004_65bf17a9-21ad-27cb-e053-2991aa0afc40.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 35 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChloraspeticMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.2b1808b2-2574-4ab8-a762-5733251848ce2024-10-25WarningsExact identifier
application number: M022
Chloraseptic Warming Sore ThroatPHENOLPrestige Brands Holdings, Inc.a197fab2-70ce-4a6c-9add-29d7368a75c52024-10-25WarningsExact identifier
application number: M022
Gly-OxideCARBAMIDE PEROXIDEMedtech Products Inc.086a0b82-e947-41c9-89e7-ba06483960c92024-10-25WarningsExact identifier
application number: M022
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.d500f423-b9f2-4d98-8f2a-8bab7c05737c2024-10-25WarningsExact identifier
application number: M022
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.b30e4b32-89dd-4e53-81d5-1415105361d42024-10-25WarningsExact identifier
application number: M022
Finafta MultiOralBENZOCAINEEfficient Laboratories Inc.28c5a993-fb5f-4091-af15-32ccae4b9a7d2024-10-14WarningsExact identifier
application number: M022
Rexall Sensitive FreshmintPOTASSIUM NITRATE, SODIUM FLUORIDEOld East Main CO.7e715bb9-666e-4de4-ba70-1c84f52434432024-10-14WarningsExact identifier
application number: M022
Rexall Sensitive Extra WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDEOld East Main CO.2daf18a3-f71e-4585-8128-4663eff7eb6d2024-10-14WarningsExact identifier
application number: M022
Anadent Kanka GelBENZOCAINEBELMORA LLCe0f73d78-5db1-43b4-8f58-e5410ca4560f2024-10-04WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLNavajo Manufacturing Company Inc.f5f26e2f-8a1f-4687-e053-2a95a90ae3782024-10-03WarningsExact identifier
application number: M022
Colgate Great Regular FlavorSODIUM MONOFLUOROPHOSPHATENavajo Manufacturing Company Inc.f89bf259-b738-8229-e053-6394a90a0c592024-10-03WarningsExact identifier
application number: M022
Colgate Total SF Clean MintSTANNOUS FLUORIDENavajo Manufacturing Company Inc.f71c53e0-e2dd-16f9-e053-6394a90accff2024-10-03WarningsExact identifier
application number: M022
Crest Pro HealthCETYLPYRIDINIUM CHLORIDENavajo Manufacturing Company Inc.65bf17a9-21ad-27cb-e053-2991aa0afc402024-10-02WarningsExact identifier
application number: M022
ndc (product): 67751-186
Sensodyne Pronamel Gentle Whitening AdvancedPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC94e07979-943b-45bb-8e2b-90d686f3692e2024-09-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Advanced PlusPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC6eb304dd-2a24-4fa0-9d39-71264e88dd162024-08-29WarningsExact identifier
application number: M022
Sensodyne Pronamel Clinical Enamel Strength Deep CleanPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcfda7efa-86fa-470d-a79f-81907e31778a2024-08-14WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Bubble TwistSODIUM FLUORIDEHaleon US Holdings LLCe403529a-0fac-4dab-b75c-46906add096b2024-08-13WarningsExact identifier
application number: M022
Calcium Carbonate Assorted FlavorsANTACID TABLETSNuCare Pharmaceuticals,Inc.af10dfb6-fef3-3410-e053-2995a90a91302024-07-17WarningsExact identifier
application number: M022
SENSODYNE Advanced Whitening PlusPOTASSIUM NITRATEHaleon US Holdings LLCf757ccdd-b316-4799-a34a-10edbb73da6b2024-07-12WarningsExact identifier
application number: M022
dentalux SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE, SODIUM FLUORIDELidl US, LLCbaef7f15-8082-4e61-8c08-8beda8ad40c02024-07-03WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN65bf17a9-21ad-27cb-e053-2991aa0afc404
1251371Crest Pro-Health 0.07 % Oral RinsePSN65bf17a9-21ad-27cb-e053-2991aa0afc404
1251371cetylpyridinium chloride 0.7 MG/ML Mouthwash [Crest Mouthwash]SBD65bf17a9-21ad-27cb-e053-2991aa0afc404
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD65bf17a9-21ad-27cb-e053-2991aa0afc404
1100924cetylpyridinium chloride 0.07 % Oral RinseSY65bf17a9-21ad-27cb-e053-2991aa0afc404
1251371Crest 0.07 % MouthwashSY65bf17a9-21ad-27cb-e053-2991aa0afc404

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-186-016775101860136 mL in 1 BOTTLE, PLASTIC (67751-186-01) 36 ml2017-12-040000-00-00NoNoCurrent