Active Ingredients And Purpose
Active ingredient
Eucalyptol (0.092%) Menthol (0.042%) Methyl Salicylate (0.060%) Thymol (0.064%)
Purposes
Antiplaque/antigingivitis
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
Key Label Information#
Uses
Uses
helps prevent and reduce plaque gingivitis
Warnings
Warning
Directions And Dosage
Directions
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 Label Information
Inactive ingredients
water, alcohol (26.9% v/v), poloxamer 407, sodium benzoate, benzoic acid, caramel
Questions or comments
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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
FAMILY WELLNESS Original Mouthwash
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1043619 | eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash | PSN | 9 |
| 1043619 | eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash | SCD | 9 |
| 1043619 | eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash | SY | 9 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-089-01 | Antiseptic | 1000 mL in 1 BOTTLE, PLASTIC | LIQUID | 1000 | 9 | |
| 55319-089-25 | Antiseptic | 250 mL in 1 BOTTLE, PLASTIC | LIQUID | 250 | 9 |
Products#
- Antiseptic
- Eucalyptol, Menthol, Methyl Salicylate, Thymol
- SALICYLIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55319-089 | 55319-089-01, 55319-089-25 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| EUCALYPTOL | RV6J6604TK | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
| METHYL SALICYLATE | LAV5U5022Y | ACTIB |
| THYMOL | 3J50XA376E | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| CARAMEL | T9D99G2B1R | IACT |
Complete SPL Sections#
Active ingredient
Eucalyptol (0.092%) Menthol (0.042%) Methyl Salicylate (0.060%) Thymol (0.064%)
Purposes
Antiplaque/antigingivitis
Uses
helps prevent and reduce plaque gingivitis
Warning
Directions
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
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
water, alcohol (26.9% v/v), poloxamer 407, sodium benzoate, benzoic acid, caramel
Questions or comments
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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
FAMILY WELLNESS Original Mouthwash
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 8 | 2025-10-31 | monthly-update | 2026-06-03 17:39:06 |
| 7 | 2025-06-02 | full-release | 2026-06-01 01:06:31 |