FDA.reportPublic FDA data

Otix Ear Relief Ear Drops

Product NDC
15579-105
11-digit product format
155790105
Labeler code
15579
Product ID
15579-105_f5739d68-cfd7-dbfd-e053-2995a90a05be
Type
HUMAN OTC DRUG
Nonproprietary name
CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
Bell Pharmaceuticals, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-08-16
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
Otix 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
15579-105-07Otix Ear Relief Ear Drops12 mL in 1 BOTTLESOLUTION/ DROPS121
15579-105-07Otix Ear Relief Ear Drops1 in 1 BOXSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15579-105OTIX EAR RELIEF EAR DROPS (CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR) SOLUTION/ DROPS [BELL PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20230228_229648d3-a0b8-415c-8b07-a51446428684.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
15579-105-07155790105071 BOTTLE in 1 BOX (15579-105-07) / 12 mL in 1 BOTTLE1 bottle2021-08-16NoNoHistorical