COOL SENSE STICK GARGLE

Product NDC
76670-0015
11-digit product format
766700015
Labeler code
76670
Product ID
76670-0015_2c4775f5-299d-f177-e063-6394a90ae2e0
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
LIQUID
Route
DENTAL
Labeler
DOCSMEDI Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-02-01
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.05 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76670-0015-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76670-0015-20efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
COOL SENSE STICK GARGLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.05 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
1251617Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d1fca5a-d01d-4362-abd8-ffdff1275bfdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76670-0015-1COOL SENSE STICK GARGLE10 mL in 1 CONTAINERLIQUID103
76670-0015-2COOL SENSE STICK GARGLE30 in 1 CARTONLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76670-0015COOL SENSE STICK GARGLE (CETYLPYRIDINIUM CHLORIDE) LIQUID [DOCSMEDI CO., LTD.]3Current NDC, 2 package rows20250123_4d1fca5a-d01d-4362-abd8-ffdff1275bfd.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOL SENSE STICK GARGLECETYLPYRIDINIUM CHLORIDEDOCSMEDI Co., Ltd.4d1fca5a-d01d-4362-abd8-ffdff1275bfd2025-01-22WarningsExact identifier
ndc (product): 76670-0015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN4d1fca5a-d01d-4362-abd8-ffdff1275bfd3
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD4d1fca5a-d01d-4362-abd8-ffdff1275bfd3
1251617cetylpyridinium chloride 0.05 % MouthwashSY4d1fca5a-d01d-4362-abd8-ffdff1275bfd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76670-0015-17667000150110 mL in 1 CONTAINER10 mlHistorical
76670-0015-27667000150230 CONTAINER in 1 CARTON (76670-0015-2) / 10 mL in 1 CONTAINER (76670-0015-1) 30 container2023-02-01NoNoCurrent