FDA.reportPublic FDA data

Crest Pro-Health

Product NDC
37000-843
11-digit product format
370000843
Labeler code
37000
Product ID
37000-843_47e49363-ea07-b3c5-e063-6294a90acf3c
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
2011-02-20
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.02 g/20mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37000-84337000-843-08DDiscontinued by firm2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Brand name suffix
Clinical
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.02 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
1291375Internal RxNorm lookup
1433894Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a295ee0-55c2-4f21-8f0a-70efc0e51694Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-843-082023-05-19Crest ® Pro-Health™ Clinical
37000-843-082023-05-19Crest ® Pro-Health™ Clinical
37000-843-162023-05-19Crest ® Pro-Health™ Clinical
37000-843-162023-05-19Crest ® Pro-Health™ Clinical
37000-843-322023-05-19Crest ® Pro-Health™ Clinical
37000-843-322023-05-19Crest ® Pro-Health™ Clinical
37000-843-082023-01-30Crest ® Pro-Health™ Clinical
37000-843-082023-01-30Crest ® Pro-Health™ Clinical
37000-843-162023-01-30Crest ® Pro-Health™ Clinical
37000-843-162023-01-30Crest ® Pro-Health™ Clinical
37000-843-322023-01-30Crest ® Pro-Health™ Clinical
37000-843-322023-01-30Crest ® Pro-Health™ Clinical
37000-843-082021-02-12Crest ® Pro-Health™ Clinical
37000-843-082021-02-12Crest ® Pro-Health™ Clinical
37000-843-162021-02-12Crest ® Pro-Health™ Clinical
37000-843-162021-02-12Crest ® Pro-Health™ Clinical
37000-843-322021-02-12Crest ® Pro-Health™ Clinical
37000-843-322021-02-12Crest ® Pro-Health™ Clinical
37000-843-082021-01-29Crest ® Pro-Health™ Clinical
37000-843-082021-01-29Crest ® Pro-Health™ Clinical
37000-843-162021-01-29Crest ® Pro-Health™ Clinical
37000-843-162021-01-29Crest ® Pro-Health™ Clinical
37000-843-322021-01-29Crest ® Pro-Health™ Clinical
37000-843-322021-01-29Crest ® Pro-Health™ Clinical

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-843-08Crest Pro-HealthClinical237 mL in 1 BOTTLE, PLASTICRINSE23710
37000-843-16Crest Pro-HealthClinical473 mL in 1 BOTTLE, PLASTICRINSE47310
37000-843-32Crest Pro-HealthClinical946 mL in 1 BOTTLE, PLASTICRINSE94610

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetylpyridinium chlorideACTIVE INGREDIENTD9OM4SK49PCREST PRO-HEALTH CLINICAL (CETYLPYRIDINIUM CHLORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
CetylpyridiniumACTIVE MOIETYCUB7JI0JV3CREST PRO-HEALTH CLINICAL (CETYLPYRIDINIUM CHLORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCREST PRO-HEALTH CLINICAL (CETYLPYRIDINIUM CHLORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
hydrogen peroxideINACTIVE INGREDIENTBBX060AN9VCREST PRO-HEALTH CLINICAL (CETYLPYRIDINIUM CHLORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2CREST PRO-HEALTH CLINICAL (CETYLPYRIDINIUM CHLORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CREST PRO-HEALTH CLINICAL (CETYLPYRIDINIUM CHLORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
waterINACTIVE INGREDIENT059QF0KO0RCREST PRO-HEALTH CLINICAL (CETYLPYRIDINIUM CHLORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-843CREST PRO-HEALTH CLINICAL (CETYLPYRIDINIUM CHLORIDE) RINSE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, Legacy NDC, 3 package rows20250110_0a295ee0-55c2-4f21-8f0a-70efc0e51694.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 36 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Attitude Adult Fluoride-free - Sensitive - SpearmintPOTASSIUM NITRATE9055-7588 Qubec Inc. DBA Attitude46d5c908-f0e3-444c-9d96-461feef391372024-05-14WarningsExact identifier
application number: M022
sensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC16225f06-1d40-416a-aaec-7890e398fe4b2024-05-13WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLQUALITY CHOICE (Chain Drug Marketing Association)9162ae27-ddbb-4336-9655-487995919de42024-05-01WarningsExact identifier
application number: M022
BIO SPECTRA ATTITUDESODIUM FLUORIDE AND POTASSIUM NITRATE9055-7588 Quebec Inc. DBA Attitude42b79ec5-f37f-4dc9-9631-c8b1c153fe882024-04-26WarningsExact identifier
application number: M022
Quality Choice Oral Pain ReliefBENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)162702b4-4bf7-8868-e063-6294a90a59212024-04-15WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc9991de96-99a1-42f0-9ddd-e530ca9ceab12024-04-11WarningsExact identifier
application number: M022
Aquafresh Extreme Clean Pure Breath ActionSODIUM FLUORIDEHaleon US Holdings LLC462eb309-deca-4464-b13a-7ae314e53ede2024-04-08WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLFamily Dollar (FAMILY WELLNESS)7806fac7-736e-44b0-baa2-42feb72374172024-03-27WarningsExact identifier
application number: M022
SucretsDYCLONINE HCL, MENTHOL, AND PECTINInsight Pharmaceuticals LLC2a2839ea-11d3-4390-930d-0da912a9c6f52024-03-20WarningsExact identifier
application number: M022
Sucrets Sore Throat Wild CherryDYCLONINE HYDROCHLORIDEInsight Pharmaceuticals LLCda4967c7-ee18-42e7-8c97-8919f3bb1b7d2024-03-20WarningsExact identifier
application number: M022
NATEAN Clean plus Sensitivity ReliefPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcea6f992-8a44-4eb8-baea-97b7b181b2272024-03-19WarningsExact identifier
application number: M022
NATEAN Clean and WhitenSODIUM FLUORIDEHaleon US Holdings LLC71b95962-2693-49f5-94d2-f2a035b5e0c82024-03-19WarningsExact identifier
application number: M022
SENSODYNE Sensitivity and Gum MintSTANNOUS FLUORIDEHaleon US Holdings LLCed093acd-255c-40ff-a010-d276f58444532024-03-07WarningsExact identifier
application number: M022
SENSODYNE Sensitivity Gum and Enamel MintSTANNOUS FLUORIDEHaleon US Holdings LLCd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e22024-03-07WarningsExact identifier
application number: M022
Sensodyne True whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC671f8f45-389c-4375-be43-f5500ee21a0e2024-03-07WarningsExact identifier
application number: M022
Sensodyne Pronamel Strong and Bright Enamel MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCbe1ae382-0e01-4db8-90d7-fdadec2ff8612024-03-06WarningsExact identifier
application number: M022
SENSODYNE Rapid ReliefSTANNOUS FLUORIDEHaleon US Holdings LLCf9589e7c-c5ca-4465-8d37-47ad6c69249f2024-03-06WarningsExact identifier
application number: M022
SENSODYNE Repair and Protect Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLC34260c69-d829-46c0-b12a-5136ee073ba12024-03-06WarningsExact identifier
application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTHPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC76adbccb-0812-4407-a6fc-a57e6f144fbb2024-03-05WarningsExact identifier
application number: M022
SENSODYNE Advanced WhiteningPOTASSIUM NITRATEHaleon US Holdings LLCa06e2549-3c4e-4818-b53e-1dea6828219f2024-03-04WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1291375cetylpyridinium chloride 0.1 % MouthwashPSN0a295ee0-55c2-4f21-8f0a-70efc0e5169410
1433894Crest Pro-Health Clinical 0.1 % Oral RinsePSN0a295ee0-55c2-4f21-8f0a-70efc0e5169410
1433894cetylpyridinium chloride 1 MG/ML Mouthwash [Crest Mouthwash]SBD0a295ee0-55c2-4f21-8f0a-70efc0e5169410
1291375cetylpyridinium chloride 1 MG/ML MouthwashSCD0a295ee0-55c2-4f21-8f0a-70efc0e5169410
1291375cetylpyridinium chloride 0.1 % MouthwashSY0a295ee0-55c2-4f21-8f0a-70efc0e5169410
1433894Crest Mouthwash 1 MG/ML MouthwashSY0a295ee0-55c2-4f21-8f0a-70efc0e5169410
1433894Crest Pro-Health Clinical 0.1 % MouthwashSY0a295ee0-55c2-4f21-8f0a-70efc0e5169410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-843-0837000084308237 mL in 1 BOTTLE, PLASTIC237 mlHistorical
37000-843-1637000084316473 mL in 1 BOTTLE, PLASTIC (37000-843-16) 473 ml2011-02-200000-00-00NoNoCurrent
37000-843-3237000084332946 mL in 1 BOTTLE, PLASTIC (37000-843-32) 946 ml2011-02-200000-00-00NoNoCurrent