FDA.reportPublic FDA data

Kalaya Breath Refresh

Manufacturer
Avaria Health and Beauty Corp
Effective date
2025-10-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:38:32

Label at a glance#

ProductKalaya Breath Refresh
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

OTC - PURPOSE SECTION

PurposePurpose

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

WARNINGS SECTION

WarningsWarnings

INDICATIONS & USAGE SECTION

UsesUses

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kalaya Oral Rinse PDPKalaya Oral Rinse PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN9
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD9
1100924cetylpyridinium chloride 0.07 % Oral RinseSY9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43493-0005-12022-02-26C16284748780-19d75b9d0-1d08-f424-e053-dadaa90a57ceKalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDC
43493-0005-12022-02-26C16284748780-19d75b9d0-1d08-f424-e053-dadaa90a57ceKalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDC
43493-0005-12022-01-28C16284748780-19d75b9d0-1d08-f424-e053-dadaa90a57ceKalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDC
43493-0005-12022-01-28C16284748780-19d75b9d0-1d08-f424-e053-dadaa90a57ceKalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDC
43493-0005-12020-04-21C16284748780-19d75b9d0-1d08-f424-e053-dadaa90a57ceKalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDC
43493-0005-12020-04-21C16284748780-19d75b9d0-1d08-f424-e053-dadaa90a57ceKalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDC
43493-0005-12020-01-31C16284748780-19d75b9d0-1d08-f424-e053-dadaa90a57ceKalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDC
43493-0005-12020-01-31C16284748780-19d75b9d0-1d08-f424-e053-dadaa90a57ceKalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDC

DailyMed Package Descriptions#

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43493-000543493-0005-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSES3NXW29V3WOIACT
WATER059QF0KO0RIACT
POLOXAMER 407TUF2IVW3M2IACT
PEPPERMINT OILAV092KU4JHIACT
SPEARMINT OILC3M81465G5IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-10-17full-release2026-06-01 00:28:33

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
Kalaya Breath RefreshMOUTHWASHAvaria Health and Beauty Corp750e99ff-72e4-3c2f-e053-2a91aa0ad5a02025-10-08WarningsExact identifier
ndc (package): 43493-0005-1
ndc (product): 43493-0005
ndc11 (package): 43493000501
spl id: 40a7a6ff-9f82-0249-e063-6294a90a257b
spl set id: 750e99ff-72e4-3c2f-e053-2a91aa0ad5a0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.