FDA.reportPublic FDA data

DEBROX

Product NDC
63029-321
11-digit product format
630290321
Labeler code
63029
Product ID
63029-321_69ef758d-a912-4696-8f5e-ac6cd1aa63dc
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Medtech Products Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-08-01
Substance
CARBAMIDE PEROXIDE
Active strength
65 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
DEBROX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE65 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31PZ2VAU81Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702050Internal RxNorm lookup
827654Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
43649ba3-75e0-4dcf-9172-23767dbaeda6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-321-01DEBROX15 mL in 1 BOTTLE, DROPPERLIQUID153
63029-321-01DEBROX1 in 1 CARTONLIQUID13
63029-321-02DEBROX1 in 1 CARTONLIQUID13
63029-321-02DEBROX15 mL in 1 BOTTLE, DROPPERLIQUID153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-321DEBROX (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]3Current NDC, Legacy NDC, 4 package rows20250124_43649ba3-75e0-4dcf-9172-23767dbaeda6.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
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 SolutionPSN8d6f1769-eb44-4bde-b3fa-3ff4658b7dd113
827654Debrox 6.5 % Otic SolutionPSN8d6f1769-eb44-4bde-b3fa-3ff4658b7dd113
827654carbamide peroxide 65 MG/ML Otic Solution [Debrox]SBD8d6f1769-eb44-4bde-b3fa-3ff4658b7dd113
702050carbamide peroxide 65 MG/ML Otic SolutionSCD8d6f1769-eb44-4bde-b3fa-3ff4658b7dd113
702050carbamide peroxide 6.5 % Otic SolutionSY8d6f1769-eb44-4bde-b3fa-3ff4658b7dd113
827654Debrox 6.5 % Otic SolutionSY8d6f1769-eb44-4bde-b3fa-3ff4658b7dd113
827654Debrox 65 MG/ML Otic SolutionSY8d6f1769-eb44-4bde-b3fa-3ff4658b7dd113
702050carbamide peroxide 6.5 % Otic SolutionPSN43649ba3-75e0-4dcf-9172-23767dbaeda63
827654Debrox 6.5 % Otic SolutionPSN43649ba3-75e0-4dcf-9172-23767dbaeda63
827654carbamide peroxide 65 MG/ML Otic Solution [Debrox]SBD43649ba3-75e0-4dcf-9172-23767dbaeda63
702050carbamide peroxide 65 MG/ML Otic SolutionSCD43649ba3-75e0-4dcf-9172-23767dbaeda63
702050carbamide peroxide 6.5 % Otic SolutionSY43649ba3-75e0-4dcf-9172-23767dbaeda63
827654Debrox 6.5 % Otic SolutionSY43649ba3-75e0-4dcf-9172-23767dbaeda63
827654Debrox 65 MG/ML Otic SolutionSY43649ba3-75e0-4dcf-9172-23767dbaeda63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63029-321-01630290321011 BOTTLE, DROPPER in 1 CARTON (63029-321-01) / 15 mL in 1 BOTTLE, DROPPER2012-08-010000-00-00NoNoCurrent
63029-321-02630290321021 BOTTLE, DROPPER in 1 CARTON (63029-321-02) / 15 mL in 1 BOTTLE, DROPPER2012-08-01NoNoCurrent