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 firm2026-10-15

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 5 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsExact identifier
application number: M022
Sensitivity and Gum with Cavity ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHealth and Natural Beauty USA Corp137d6935-19a3-499d-957c-820156eec7a52026-05-22WarningsExact identifier
application number: M022
SEXYTEETH MINTY T00THPASTESEXYTEETH MINTY TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51d288c1-fe86-ffe1-e063-6394a90ab4c42026-05-14WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat cherryBENZOCAINE AND MENTHOLReckitt Benckiser LLC941e36dd-d8d0-4e5c-8585-10e8f06bf8f02026-05-12WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat honey lemonBENZOCAINE AND MENTHOLReckitt Benckiser LLCd771095b-7de3-48f3-a125-8bc76e7d17782026-05-12WarningsExact identifier
application number: M022
SEXYTEETH CHARCOAL T00THPASTESEXYTEETH CHARCOAL TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51ab8a9a-6c12-b13b-e063-6294a90ace2a2026-05-12WarningsExact identifier
application number: M022
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash AnticavityFLUORIDEWHOLE FOODS25bc7ab1-116d-143a-e063-6394a90aa9702026-05-04WarningsExact identifier
application number: M022
Gingicaine Gel StrawberryGINGICAINE GEL STRAWBERRY FLAVORGingi-Pak a Division of the Belport2fd37612-a28b-3aa1-e054-00144ff8d46c2026-05-01WarningsExact identifier
application number: M022
3ECARE Dual formula WhiteningToothpaste RefillSODIUM FLUORIDEHangzhou Namei Zhikang Technology Co., Ltd.501df1c7-4884-bb39-e063-6294a90aaf6a2026-04-23WarningsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Inc1f10a72f-0b49-41cb-92f9-b0160d7664de2026-04-22WarningsExact identifier
application number: M022
EverSmile AlignerFresh Enamel GuardSODIUM FLUORIDEEverbrands, Inc.7b3d0114-dac0-4370-8545-922ec018018e2026-04-21WarningsExact identifier
application number: M022
PREOPHYDROGEN PEROXIDEEverbrands, Inc.cc5cdd29-92c1-4ce0-997e-eb624b288b092026-04-20WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINECVSa7576238-e7c8-7e86-e053-2995a90aaeb52026-04-20WarningsExact identifier
application number: M022
CVS Pharmacy Maximum StrengthBENZOCAINECVS Pharmacy92747826-cf58-4406-b3b5-12f7c7077c2c2026-04-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)9f991292-bbaa-4f4e-b2cb-059d1a04849e2026-04-20WarningsExact identifier
application number: M022
Osstem S Sensitivity relief toothPOTASSIUM NITRATE, SODIUM FLUORIDEOsstem Pharma Co., Ltd4f8ab179-8f29-a7cf-e063-6294a90a0c222026-04-15WarningsExact identifier
application number: M022
Crest Pro-Health Gum DetoxifyWinter MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6db58f-0b09-d155-e063-6394a90ae6582026-04-14WarningsExact identifier
application number: M022
Lolleez Orange MangoPECTINBFY LLC4f6dec8b-078a-f321-e063-6294a90a248c2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Gum Restore Smooth MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6e3b36-e565-7d27-e063-6294a90ae5ac2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Nightly Bacteria ShieldCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6ec1e0-c6b5-226f-e063-6294a90a8f142026-04-14WarningsExact 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