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 4 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Best Choice Earwax Removal DropsCARBAMIDE PEROXIDEValu Merchandisers Company3ae6255f-f494-412b-af76-3579de08ed232025-02-28WarningsExact identifier
application number: M014
Equaline Earwax Removal DropsCARBAMIDE PEROXIDEUnited Natural Foodsd853567a-ce8d-40a8-be1e-27176802ff642025-02-28WarningsExact identifier
application number: M014
Family Wellness Earwax Removal Earwax and BulbCARBAMIDE PEROXIDEFamily Dollar Services Inc26ebf208-4710-4af2-aa2d-b2040b85cf852025-02-28WarningsExact identifier
application number: M014
FOSTER AND THRIVE EARWAX REMOVAL DROPSCARBAMIDE PEROXIDEA-S Medication Solutions0a571ae8-237b-447d-b697-02b30692b6b12025-02-24WarningsExact identifier
application number: M014
Pain Be GoneMENTHOLBack to Earth Inc.f49e718b-ef89-b648-e053-2a95a90a96c82025-01-29WarningsExact identifier
application number: M014
DEBROXCARBAMIDE PEROXIDEMedtech Products Inc.43649ba3-75e0-4dcf-9172-23767dbaeda62025-01-27WarningsExact identifier
application number: M014
ndc (product): 63029-321
HylaTearsEYE DROPSHyalogic LLC2b5fc4c4-843c-8d3d-e063-6394a90a5a1b2025-01-10WarningsExact identifier
application number: M014
BODYOGRAPHYPRO ANTI-BACTERIAL SANITIZINGETHYL ALCOHOLRobanda International, Inc.ebec43d4-4676-40f9-b989-5381f4a737c82025-01-08WarningsExact identifier
application number: M014
Dr. TalbotsETHYL ALCOHOLTalbots Pharmaceuticals Family Products, LLC.a6a94205-a9ff-7709-e053-2995a90a066b2025-01-08WarningsExact identifier
application number: M014
Foster and Thrive Earwax Removal Kit Ear wax dropsCARBAMIDE PEROXIDEMckesson Corp. Via Strategic Sourcing Servicesc9bd4c1f-b3b8-4bdc-b529-3a98b657e6282024-12-31WarningsExact identifier
application number: M014
Foster and Thrive Earwax Removal DropsCARBAMIDE PEROXIDEMckesson Corp. Via Strategic Sourcing Services6180835c-d7a7-4bf7-95cb-0fd3c81402532024-12-31WarningsExact identifier
application number: M014
OIDO SANAISOPROPYL ALCOHOLProMex LLC71e84695-49e8-459f-ac5e-118b5235fe062024-12-18WarningsExact identifier
application number: M014
ERO Ear Wax Removal KitCARBAMIDE PEROXIDE 6.5%Randob Labsfbf8a6f2-531d-5047-e053-6294a90aaa012024-12-15WarningsExact identifier
application number: M014
Harris Teeter Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Harris Teeter LLCdda4c4bf-425e-4fff-e053-2a95a90a51bc2024-12-15WarningsExact identifier
application number: M014
Isopropyl AlcoholISOPROPYL ALCOHOLMazza Healthcare, LLCee83ba9f-ac65-48b7-9f84-5be6fec9a9092024-11-21WarningsExact identifier
application number: M014
Ear Wax Removal Drops Up and UpCARBAMIDE PEROXIDE - 6.5%Target Corporation829ece50-1f26-4f69-b000-010a34d4cd542024-11-21WarningsExact identifier
application number: M014
Walgreens Ear Wax RemoverCARBAMIDE PEROXIDE 6.5%Walgreens Companyd3b7362b-2826-4b86-bfa3-ef302dc791432024-11-20WarningsExact identifier
application number: M014
CLEARCANAL EAR WAX SOFTERNER DROPSCARBAMIDE PEROXIDEA-S Medication Solutionsac3d57a4-08d5-45f1-be84-f68eef9d13982024-11-04WarningsExact identifier
application number: M014
Caladryl ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEBausch Health US, LLCfca6f08b-7fa0-4ae6-bce3-61f3bcae43322024-10-17WarningsExact identifier
application number: M014
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact 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