FDA.reportPublic FDA data

Family Wellness

Manufacturer
Family Dollar Services Inc.
Effective date
2021-08-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:42:02

Label at a glance#

ProductFamily Wellness Total Health
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Cetylpyridinium chloride 0.07%

OTC - PURPOSE SECTION

Purpose

Antigingivitis, Antiplaque

INDICATIONS & USAGE SECTION

Usehelps control plaque that leads to gingivitis

WARNINGS SECTION

Warnings

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 6 years of age and older: use twice a day after brushing your teeth with toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients water, glycerin, flavor, poloxamer 407, sodium saccharin and/or sucralose, citric acid, 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 Proctor and Gamble, distributor of Crest®.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO CREST® PRO HEALTH*

FAMILY wellness™

ALCOHOL FREE

TOTAL HEALTH

MOUTH RINSE

MULTI-ACTION ANTISEPTIC

  • Kills Germs that Cause Bad Breath, Plaque and Gingivitis
  • Freshens Breath
  • Helps Keep Mouth Feeling Clean
  • No Burn of Alcohol

33.8 FL OZ (1000 mL)

Total Health Mouth RinseTotal Health Mouth Rinse

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN3
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD3
1100924cetylpyridinium chloride 0.07 % Oral RinseSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-234-862023-01-30C16284748780-1c7ccaba7-1d7f-fd44-e053-dadaa90aa01bFamily Wellness Total Health Mouth Rinse Alcohol Free
55319-234-862021-08-23C16284748780-1c7ccaba7-1d7f-fd44-e053-dadaa90aa01bFamily Wellness Total Health Mouth Rinse Alcohol Free
55319-234-862021-07-23C16284748780-1c7ccaba7-1d7f-fd44-e053-dadaa90aa01bFamily Wellness Total Health Mouth Rinse Alcohol Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-234-86Family WellnessTotal Health1000 mL in 1 BOTTLE, PLASTICRINSE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-234FAMILY WELLNESS TOTAL HEALTH (CETYLPYRIDINIUM CHLORIDE) RINSE [FAMILY DOLLAR SERVICES INC.]3Legacy NDC, 1 package rows20210824_8bdb83b2-7e54-862a-e053-2a95a90a6f39.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-23455319-234-86

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
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
POLOXAMER 407TUF2IVW3M2IACT
SUCRALOSE96K6UQ3ZD4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML

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-998d-4aad-e053-2a95a90af03b8bdb83b2-7e54-862a-e053-2a95a90a6f392021-08-23WarningsExact identifier
spl id: ca3e9f1a-998d-4aad-e053-2a95a90af03b
spl set id: 8bdb83b2-7e54-862a-e053-2a95a90a6f39

Reported adverse events (FAERS/openFDA)#

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