DEBROX

Product NDC
50090-4201
11-digit product format
500904201
Labeler code
50090
Product ID
50090-4201_b34a6756-91f6-448d-be3f-a40632075df0
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
A-S Medication Solutions
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
50090-4201-0DEBROX15 mL in 1 BOTTLE, DROPPERLIQUID1513
50090-4201-0DEBROX1 in 1 CARTONLIQUID113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4201-0ML - Milliliter50090-4201f5f268aa-6a66-4d3b-abf8-0a77c033102e12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4201DEBROX (CARBAMIDE PEROXIDE) LIQUID [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20231206_8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4201-0500904201001 BOTTLE, DROPPER in 1 CARTON (50090-4201-0) / 15 mL in 1 BOTTLE, DROPPER2019-03-190000-00-00NoNoCurrent