Kalaya Breath Refresh

Product NDC
43493-0005
11-digit product format
434930005
Labeler code
43493
Product ID
43493-0005_40a7a6ff-9f82-0249-e063-6294a90a257b
Type
HUMAN OTC DRUG
Nonproprietary name
Mouthwash
Dosage form
LIQUID
Route
ORAL
Labeler
Avaria Health and Beauty Corp
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-16
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.7 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kalaya Breath Refresh
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.7 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9OM4SK49P
Rxcui1100924

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43493-0005-1Kalaya Breath Refresh500 mL in 1 BOTTLE, DISPENSINGLIQUID5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43493-0005KALAYA BREATH REFRESH (MOUTHWASH) LIQUID [AVARIA HEALTH AND BEAUTY CORP]8Current NDC, Legacy NDC, 1 package rows20241024_750e99ff-72e4-3c2f-e053-2a91aa0ad5a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN750e99ff-72e4-3c2f-e053-2a91aa0ad5a09
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD750e99ff-72e4-3c2f-e053-2a91aa0ad5a09
1100924cetylpyridinium chloride 0.07 % Oral RinseSY750e99ff-72e4-3c2f-e053-2a91aa0ad5a09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43493-0005-143493000501500 mL in 1 BOTTLE, DISPENSING (43493-0005-1) 500 ml2018-11-160000-00-00NoNoCurrent