FDA.reportPublic FDA data

Family Wellness

Manufacturer
Family Dollar Services Inc.
Effective date
2021-08-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:42:02

Label at a glance#

ProductFamily Wellness Original Amber
Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Label structure10 sections

Storage and handling

Other information cold weather may cloud this product. Its antiseptic properties are not affected . Store at room temperature (59° - 77°F)

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

Usehelps 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 periodontitis, 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 OS or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

– children under 12 years of age: consult a dentist or doctor

• 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° - 77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients water, alcohol 21.6%, benzoic acid, poloxamer 407, sodium benzoate, caramel.

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® ORIGINAL*

FAMILY wellness™

ORIGINAL AMBER

MOUTHWASH

DEEP CLEAN FOR FRESHER BREATH

Helps Kill Germs that Cause Bad Breath, Plaque and Gingivitis Gum Disease

33.8 FL OZ (1000 mL)

aa

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN4
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD4
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY4

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-232-232023-01-30C16284748780-1c7ccaba7-1659-fd44-e053-dadaa90aa01bFamily Wellness Original Amber Mouthwash
55319-232-862023-01-30C16284748780-1c7ccaba7-1659-fd44-e053-dadaa90aa01bFamily Wellness Original Amber Mouthwash
55319-232-232021-08-23C16284748780-1c7ccaba7-1659-fd44-e053-dadaa90aa01bFamily Wellness Original Amber Mouthwash
55319-232-862021-08-23C16284748780-1c7ccaba7-1659-fd44-e053-dadaa90aa01bFamily Wellness Original Amber Mouthwash
55319-232-232021-07-23C16284748780-1c7ccaba7-1659-fd44-e053-dadaa90aa01bFamily Wellness Original Amber Mouthwash
55319-232-862021-07-23C16284748780-1c7ccaba7-1659-fd44-e053-dadaa90aa01bFamily Wellness Original Amber Mouthwash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-232-23Family WellnessOriginal Amber250 mL in 1 BOTTLE, PLASTICMOUTHWASH2504
55319-232-86Family WellnessOriginal Amber1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-232FAMILY WELLNESS ORIGINAL AMBER (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [FAMILY DOLLAR SERVICES INC.]4Legacy NDC, 2 package rows20210824_8bc728f7-3ec7-4f4e-e053-2a95a90ae844.zip

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
55319-23255319-232-86, 55319-232-23

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
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
POLOXAMER 407TUF2IVW3M2IACT
BENZOIC ACID8SKN0B0MIMIACT
CARAMELT9D99G2B1RIACT
EUCALYPTOLRV6J6604TKACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB

Source Document#

Source XML · Source PDF

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
ca3e9f1a-998c-4aad-e053-2a95a90af03b8bc728f7-3ec7-4f4e-e053-2a95a90ae8442021-08-23WarningsExact identifier
spl id: ca3e9f1a-998c-4aad-e053-2a95a90af03b
spl set id: 8bc728f7-3ec7-4f4e-e053-2a95a90ae844

Reported adverse events (FAERS/openFDA)#

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