FDA.reportPublic FDA data

Otix Ear wax Removal System Ear wax and Bulb

Product NDC
15579-839
11-digit product format
155790839
Labeler code
15579
Product ID
15579-839_0c7fb23c-2434-ee25-e063-6394a90a9f53
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
KIT
Labeler
Bell Pharmaceuticals, Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-01
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 wax Removal System Ear wax and Bulb
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui702050, 2588948

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15579-838-34Otix Ear wax Removal System Ear wax and Bulb15 mL in 1 BOTTLESOLUTION/ DROPS15 mL65 mg in 1mL2
15579-838-34Otix Ear wax Removal System Ear wax and Bulb1 in 1 BOXSOLUTION/ DROPS65 mg in 1mL2
15579-839-33Otix Ear wax Removal System Ear wax and Bulb1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15579-839OTIX EAR WAX REMOVAL SYSTEM EAR WAX AND BULB (CARBAMIDE PEROXIDE) KIT [BELL PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20231219_15868798-28cd-4495-9baf-711e81ad8bdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN15868798-28cd-4495-9baf-711e81ad8bdd2
2588948Otix 6.5 % Otic SolutionPSN15868798-28cd-4495-9baf-711e81ad8bdd2
2588948carbamide peroxide 65 MG/ML Otic Solution [Otix]SBD15868798-28cd-4495-9baf-711e81ad8bdd2
702050carbamide peroxide 65 MG/ML Otic SolutionSCD15868798-28cd-4495-9baf-711e81ad8bdd2
702050carbamide peroxide 6.5 % Otic SolutionSY15868798-28cd-4495-9baf-711e81ad8bdd2
2588948Otix 65 MG/ML Otic SolutionSY15868798-28cd-4495-9baf-711e81ad8bdd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15579-838-341557908383415 mL in 1 BOTTLE15 mlHistorical
15579-839-33155790839331 KIT in 1 KIT (15579-839-33) * 1 BOTTLE in 1 BOX (15579-838-34) / 15 mL in 1 BOTTLE1 kit2021-10-010000-00-00NoNoCurrent