NDC 43493-0005

Kalaya Breath Refresh

Mouthwash

Kalaya Breath Refresh is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Avaria Health And Beauty Corp. The primary component is Cetylpyridinium Chloride.

Product ID43493-0005_23bd21ae-e47f-47da-9bb1-9cb66d260f06
NDC43493-0005
Product TypeHuman Otc Drug
Proprietary NameKalaya Breath Refresh
Generic NameMouthwash
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2018-11-16
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameAvaria Health and Beauty Corp
Substance NameCETYLPYRIDINIUM CHLORIDE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 43493-0005-1

500 mL in 1 BOTTLE, DISPENSING (43493-0005-1)
Marketing Start Date2018-11-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43493-0005-1 [43493000501]

Kalaya Breath Refresh LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-16
Inactivation Date2020-01-31
Reactivation Date2020-04-21

Drug Details

Active Ingredients

IngredientStrength
CETYLPYRIDINIUM CHLORIDE.7 mg/mL

OpenFDA Data

SPL SET ID:750e99ff-72e4-3c2f-e053-2a91aa0ad5a0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1100924

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