Ear Drops

Product NDC
50090-5273
11-digit product format
500905273
Labeler code
50090
Product ID
50090-5273_bac0c4d3-f01c-4ade-a739-51480e272328
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide 6.5%
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
A-S Medication Solutions
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-10
Substance
CARBAMIDE PEROXIDE
Active strength
6.5 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ear Drops
Brand name suffix
Major
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE6.5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5273-02024-01-08C16284748780-1f386c64a-18ea-0266-e053-dadaa90a7c1aEar Drops Major
50090-5273-02023-01-30C16284748780-1f386c64a-18ea-0266-e053-dadaa90a7c1aEar Drops Major

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5273-0Ear DropsMajor15 mL in 1 BOTTLELIQUID156
50090-5273-0Ear DropsMajor1 in 1 CARTONLIQUID16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5273-0ML - Milliliter50090-527353def603-5221-484a-9ef1-47c7a534288212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5273EAR DROPS MAJOR (CARBAMIDE PEROXIDE 6.5%) LIQUID [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240109_eb7df1cc-50db-479a-bc1c-dfd7004dd35b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNeb7df1cc-50db-479a-bc1c-dfd7004dd35b6
702050carbamide peroxide 65 MG/ML Otic SolutionSCDeb7df1cc-50db-479a-bc1c-dfd7004dd35b6
702050carbamide peroxide 6.5 % Otic SolutionSYeb7df1cc-50db-479a-bc1c-dfd7004dd35b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5273-0500905273001 BOTTLE in 1 CARTON (50090-5273-0) / 15 mL in 1 BOTTLE1 bottle2020-10-200000-00-00NoNoCurrent