Cool Sense Concentrated

Product NDC
76670-0017
11-digit product format
766700017
Labeler code
76670
Product ID
76670-0017_456c3296-aae9-94cf-e063-6394a90a373a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
MOUTHWASH
Route
DENTAL
Labeler
DOCSMEDI Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-12-01
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
2.296 g/100mL
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
Cool Sense Concentrated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE2.296 g/100mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2590919Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
456c2d06-224b-6ba8-e063-6294a90a40acAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76670-0017-1Cool Sense Concentrated50 mL in 1 CONTAINERMOUTHWASH501
76670-0017-2Cool Sense Concentrated1 in 1 CARTONMOUTHWASH11

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cool Sense ConcentratedCETYLPYRIDINIUM CHLORIDEDOCSMEDI Co., Ltd.456c2d06-224b-6ba8-e063-6294a90a40ac2025-12-08WarningsExact identifier
ndc (product): 76670-0017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2590919cetylpyridinium chloride 2.3 % Concentrated MouthwashPSN456c2d06-224b-6ba8-e063-6294a90a40ac1
2590919cetylpyridinium chloride 23 MG/ML MouthwashSCD456c2d06-224b-6ba8-e063-6294a90a40ac1
2590919cetylpyridinium chloride 2.296 % MouthwashSY456c2d06-224b-6ba8-e063-6294a90a40ac1
2590919cetylpyridinium chloride 2.3 % MouthwashSY456c2d06-224b-6ba8-e063-6294a90a40ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76670-0017-17667000170150 mL in 1 CONTAINER50 mlHistorical
76670-0017-2766700017021 CONTAINER in 1 CARTON (76670-0017-2) / 50 mL in 1 CONTAINER (76670-0017-1) 1 container2025-12-01NoNoCurrent