FDA.reportPublic FDA data

Crest

Product NDC
84126-640
11-digit product format
841260640
Labeler code
84126
Product ID
84126-640_4f1db6b3-e03a-8431-e063-6394a90afd63
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
2026-01-06
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.014 g/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Brand name suffix
Scope Original Clean Mint
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D9OM4SK49PInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f1db6f4-acd7-a665-e063-6294a90a826bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-640-25CrestScope Original Clean Mint250 mL in 1 BOTTLERINSE2501

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 26 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.69271b7a-18c0-4445-8164-cb1620fb54752025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.40bd7406-7ee6-47fe-8481-0a4c8cefce652025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.43194fe1-87a1-4ffa-ad73-a1dcec91fd632025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.b0b3ab27-704a-44b8-8473-d21ac3359ba12025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.39f64f10-f442-45a9-a060-9f99e78c678d2025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.ed5a294a-fc03-43dd-825d-23a2320609002025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.be558e5b-cf35-4035-a69c-8d66deeac6b22025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.a2591a96-ed66-45b1-abf6-6b26d0bb4f442025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.efe92e48-5086-4b61-a298-0d8ceefe100e2025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.1d6a1182-ab63-460a-ab91-8d4c2ae5d01e2025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.e1db79a4-4a24-4c3f-9ee9-2af3f876ac962025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.d3b6669e-479f-4bc1-b533-5e9a0cc652132025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.e42a22ef-1035-4dd0-94b0-43625542d5842025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.3dca05de-cf63-4ca0-88be-473ea637e6b42025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.d6149dfd-f2a5-4bbd-913c-6a95efe5ffd22025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.c6eda1de-4490-4a28-8a31-cbf3e102e74e2025-01-09WarningsExact identifier
application number: M022
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc4261cd90-5087-44a3-bef9-72d33dbf0dfd2025-01-09WarningsExact identifier
application number: M022
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Ince70240a8-fa9d-4005-a3a0-5cca6188bf612025-01-09WarningsExact identifier
application number: M022
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incfda3d254-e103-4be9-9086-51ad022b2b3f2025-01-09WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalc161da79-9ea5-4c7f-890c-4315129fe5bf2025-01-08WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-640-2584126064025250 mL in 1 BOTTLE (84126-640-25) 250 ml2026-01-06NoNoCurrent