Storage and handling
Other information cold weather may cloud this product. Its antiseptic properties are not affected . Store at room temperature (59° - 86°F)
Family Wellness
- Manufacturer
- Family Dollar Services Inc.
- Effective date
- 2021-08-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:42:03
Label at a glance#
ProductFamily Wellness Ultra Mouthwash
Active ingredientMENTHOL, UNSPECIFIED FORM, THYMOL, EUCALYPTOL, METHYL SALICYLATE
Label structure10 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Eucalyptol 0.092%, Menthol 0.042%
Methyl salicylate 0.060%, Thymol 0.064%
OTC - PURPOSE SECTION
Purpose
Antigingivitis, Antiplaque
Antigingivitis, Antiplaque
INDICATIONS & USAGE SECTION
Use helps control plaque that leads to gingivitis
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodonititis, a serious form of gum disease.
OTC - STOP USE SECTION
Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
| adults and children 12 years of age and older | vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow |
| children 6 years to under 12 years of age | supervise use |
| children under 6 years | do not use |
- This rinse is not intended to replace brushing or flossing
STORAGE AND HANDLING SECTION
Other information cold weather may cloud this product. Its antiseptic properties are not affected . Store at room temperature (59° - 86°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, flavor, sodium saccharin, blue 1.
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY: Midwood Brands, LLC
500 Volvo Parkway, Chesapeake, VA 23320
Made in Canada
* This product is not manufactured or distributed by Johnson & Johnson, distributor of Listerine®.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
COMPARE TO LISTERINE® ULTRACLEAN*
FAMILY wellness™
ULTRA
MOUTHWASH
ANTISEPTIC MOUTHRINSE
Helps Kill Germs that Cause Bad Breath, Plaque and Gingivitis Gum Disease
3.8 FL OZ (1000 mL)
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 | 2 |
| 1043619 | eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash | SCD | 2 |
| 1043619 | eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash | SY | 2 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55319-319-86 | 2023-01-30 | C162847 | 48780-1 | c7ccaba7-2319-fd44-e053-dadaa90aa01b | Family Wellness Ultra Mouthrinse, Arctic Mint |
| 55319-319-86 | 2021-08-23 | C162847 | 48780-1 | c7ccaba7-2319-fd44-e053-dadaa90aa01b | Family Wellness Ultra Mouthrinse, Arctic Mint |
| 55319-319-86 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-2319-fd44-e053-dadaa90aa01b | Family Wellness Ultra Mouthrinse, Arctic Mint |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-319-86 | Family WellnessUltra Mouthwash | 1000 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1000 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Family Wellness Ultra Mouthwash
- Eucalyptol, Menthol, Methyl Salicylate, Thymol
- MENTHOL, UNSPECIFIED FORM
- BENZOIC ACID
- SORBITOL
- SUCRALOSE
- POLOXAMER 407
- WATER
- ALCOHOL
- SODIUM BENZOATE
- SACCHARIN SODIUM
- SACCHARIN
- FD&C BLUE NO. 1
- THYMOL
- ZINC CHLORIDE
- EUCALYPTOL
- METHYL SALICYLATE
- SALICYLIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55319-319 | 55319-319-86 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| THYMOL | 3J50XA376E | ACTIB |
| ZINC CHLORIDE | 86Q357L16B | IACT |
| EUCALYPTOL | RV6J6604TK | ACTIB |
| METHYL SALICYLATE | LAV5U5022Y | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ca3e6d6c-4118-4016-e053-2a95a90abfcc | a93ca8e8-9b82-44a6-e053-2a95a90aa9e7 | 2021-08-23 | Warnings | ca3e6d6c-4118-4016-e053-2a95a90abfcc a93ca8e8-9b82-44a6-e053-2a95a90aa9e7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.