FDA.reportPublic FDA data

Equaline Ear Relief Ear Drops

Product NDC
41163-846
11-digit product format
411630846
Labeler code
41163
Product ID
41163-846_2f3978df-639b-8d46-e063-6294a90ac8f8
Type
HUMAN OTC DRUG
Nonproprietary name
CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
United Natural Foods, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2005-12-01
Substance
CHAMOMILE; 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHAMOMILE10 [hp_X]/mL
MERCURIUS SOLUBILIS15 [hp_X]/mL
SULFUR12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFGL3685T2X, 324Y4038G2, 70FD1KFU70

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-846-07Equaline Ear Relief Ear Drops1 in 1 BOXSOLUTION/ DROPS12
41163-846-07Equaline Ear Relief Ear Drops12 mL in 1 BOTTLESOLUTION/ DROPS122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-846EQUALINE EAR RELIEF EAR DROPS (CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR) SOLUTION/ DROPS [UNITED NATURAL FOODS, INC.]2Current NDC, Legacy NDC, 2 package rows20250306_1178cdcf-860d-42b7-974f-346485311a2f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-846-07411630846071 BOTTLE in 1 BOX (41163-846-07) / 12 mL in 1 BOTTLE1 bottle2005-12-010000-00-00NoNoCurrent