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 UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FGL3685T2XInternal 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
229648d3-a0b8-415c-8b07-a51446428684Available on FDA.report

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

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
Otix Ear Relief Ear DropsCHAMOMILE, MERCURIUS SOLUBILIS, SULFURBell Pharmaceuticals, Inc.229648d3-a0b8-415c-8b07-a514464286842023-02-24WarningsExact identifier
ndc (product): 15579-105

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 bottle2021-08-16NoNoCurrent