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
2027-12-31
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
Otix Ear wax Removal System Ear wax and Bulb
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702050Internal RxNorm lookup
2588948Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
15868798-28cd-4495-9baf-711e81ad8bddAvailable on FDA.report

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

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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
application number: M014
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
application number: M014
Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.15868798-28cd-4495-9baf-711e81ad8bdd2023-12-14WarningsExact identifier
application number: M014
ndc (product): 15579-839
Otix Ear wax Removal DropsCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.0e70ab09-9360-4ab6-a1fe-6f82af3925812023-12-14WarningsExact identifier
application number: M014
TopCare Earwax Removal DropsCARBAMIDE PEROXIDETopco Associates LLCc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2023-12-14WarningsExact identifier
application number: M014
DG Health Earwax Removal kitCARBAMIDE PEROXIDE 6.5%DOLLAR GENERAL CORPORATION4b6fc00f-72d7-4675-9881-b763f27c06e32023-12-07WarningsExact identifier
application number: M014
Ear Wax Removal Drops EquateCARBAMIDE PEROXIDE - 6.5%WALMART STORES INC33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d2023-12-04WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEProficient Rx LPa131447b-a5a0-45cd-a59c-a9f719275baa2023-12-01WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact identifier
application number: M014

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