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 firm2026-10-05

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 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CrystLCare Regeneration PlusPOTASSIUM NITRATE, SODIUM FLUORIDEGreenMark Biomedical Inc.4f86d0a0-d73e-5605-e063-6394a90adb382026-09-14WarningsExact identifier
application number: M022
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
application number: M022
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
application number: M022
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
application number: M022
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
application number: M022
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
application number: M022
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
application number: M022
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEAmerisourceBergen (Good Neighbor Pharmacy) 461220733015b-e81a-4a62-82ad-dacaf3f163cb2026-09-02WarningsExact identifier
application number: M022
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORTHEXYLRESORCINOLReckitt Benckiser LLC91cd2964-5d83-4e40-bc18-e3e5462f454a2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
application number: M022
LUDENS SUGAR FREE WILD CHERRY THROATPECTINPrestige Brands Holdings, Inc.274fc80c-e5b2-41c7-a119-287d6e8a22582026-08-28WarningsExact identifier
application number: M022
Medline Peroxi Fresh MouthwashHYDROGEN PEROXIDEMedline Industries, LPec7a9240-6c66-4471-b8b6-776e08a14fbc2026-08-27WarningsExact identifier
application number: M022
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact 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