FDA.reportPublic FDA data

Kalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDC

Manufacturer
Family Dollar (FAMILY WELLNESS)
Effective date
2026-04-20
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:54:28

Label at a glance#

ProductAntiseptic
Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Label structure10 sections

Indications and uses

helps prevent and reduce plaque gingivitis

Dosage and administration

adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Eucalyptol (0.092%)

Menthol (0.042%)

Methyl Salicylate (0.060%)

Thymol (0.064%)

Purposes

OTC - PURPOSE SECTION

Antiplaque/antigingivitis

Uses

INDICATIONS & USAGE SECTION

helps prevent and reduce

  • plaque
  • gingivitis

Warning

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

in children under 12 years of age.

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • children 6 years to under 12 years of age: supervise use
  • children under 6 years of age: do not use

Other information

OTHER SAFETY INFORMATION

  • store at room temperature
  • cold weather may cloud this product. Its antiseptic properties are not affected.
  • this rinse is nor intended to replace brushing or flossing 

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol (26.9% v/v), poloxamer 407, sodium benzoate, benzoic acid, caramel

Questions or comments

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENTS IN LISTERINE®*

ORIGINAL

ANTISEPTIC

MOUTHWASH

Antigingivitis/Antiplaque Mouthwash

Eucalyptol (0.092%)

Menthol (0.042%)

Methyl salicylate (0.060%)

Thymol (0.064%)

  • Kill germs that cause plaque, gingivitis, bad breath
  • Helps to control and prevent plaque that leads to gingivitis

mL (fl oz)

*This product is not manufactured or distributed by Kenvue Brands LLC, distributor of Listerine®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

510 VOLVO PKWY, CHESAPEAKE, VA 23320 

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY WELLNESS Original Mouthwash
FAMILY WELLNESS Original Mouthwash

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN9
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD9
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130032251741104GTIN-13: 0032251741104
EAN-13: 0032251741104
GTIN-12: 032251741104
UPC-A: 032251741104
GTIN storage (14 digits): 00032251741104		mouthwash-original-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-089-01Antiseptic1000 mL in 1 BOTTLE, PLASTICLIQUID10009
55319-089-25Antiseptic250 mL in 1 BOTTLE, PLASTICLIQUID2509

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-08955319-089-01, 55319-089-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTOLRV6J6604TKACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
POLOXAMER 407TUF2IVW3M2IACT
BENZOIC ACID8SKN0B0MIMIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARAMELT9D99G2B1RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-10-31monthly-update2026-06-03 17:39:06
72025-06-02full-release2026-06-01 01:06:31

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
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)9f991292-bbaa-4f4e-b2cb-059d1a04849e2026-04-20WarningsExact identifier
ndc (package): 55319-089-01
ndc (package): 55319-089-25
ndc (product): 55319-089
ndc11 (package): 55319008901
ndc11 (package): 55319008925
spl id: 538277bd-6e12-40c3-af57-c1c6891a1a56
spl set id: 9f991292-bbaa-4f4e-b2cb-059d1a04849e