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

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 Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050, 827654

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

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