Family Wellness Ear Relief Ear Drops

Product NDC
55319-804
11-digit product format
553190804
Labeler code
55319
Product ID
55319-804_28d9b093-3d3d-4353-e063-6394a90a8d4e
Type
HUMAN OTC DRUG
Nonproprietary name
MATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFUR
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Family Dollar Services Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-11-01
Substance
MATRICARIA CHAMOMILLA; MERCURIUS SOLUBILIS; SULFUR
Active strength
10; 15; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Family Wellness Ear Relief Ear Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MATRICARIA CHAMOMILLA10 [hp_X]/mL
MERCURIUS SOLUBILIS15 [hp_X]/mL
SULFUR12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G0R4UBI2ZZInternal UNII lookup
324Y4038G2Internal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dba89b5c-fe1d-485d-a1af-d8cd1f15b615Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-804-01Family Wellness Ear Relief Ear Drops12 mL in 1 BOTTLESOLUTION/ DROPS122
55319-804-01Family Wellness Ear Relief Ear Drops1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-804FAMILY WELLNESS EAR RELIEF EAR DROPS (MATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFUR) SOLUTION/ DROPS [FAMILY DOLLAR SERVICES INC]2Current NDC, Legacy NDC, 2 package rows20241210_dba89b5c-fe1d-485d-a1af-d8cd1f15b615.zip

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
Family Wellness Ear Relief Ear DropsMATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFURFamily Dollar Services Incdba89b5c-fe1d-485d-a1af-d8cd1f15b6152024-12-09WarningsExact identifier
ndc (product): 55319-804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-804-01553190804011 BOTTLE in 1 CARTON (55319-804-01) / 12 mL in 1 BOTTLE1 bottle2019-11-010000-00-00NoNoCurrent