Audiologists Choice Earwax Removal System

Product NDC
59256-001
11-digit product format
592560001
Labeler code
59256
Product ID
59256-001_0c86777f-3d1a-5e1d-e063-6294a90a2369
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Oaktree Products Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-28
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
Audiologists Choice Earwax Removal System
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE65 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59256-001-02Audiologists Choice Earwax Removal System15 mL in 1 BOTTLE, DISPENSINGLIQUID154
59256-001-02Audiologists Choice Earwax Removal System1 in 1 CARTONLIQUID14

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59256-001AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE) LIQUID [OAKTREE PRODUCTS INC.]4Current NDC, Legacy NDC, 2 package rows20231215_c9ad507b-341c-474f-aaa2-3c3a97a30dd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNc9ad507b-341c-474f-aaa2-3c3a97a30dd85
702050carbamide peroxide 65 MG/ML Otic SolutionSCDc9ad507b-341c-474f-aaa2-3c3a97a30dd85
702050carbamide peroxide 6.5 % Otic SolutionSYc9ad507b-341c-474f-aaa2-3c3a97a30dd85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59256-001-02592560001021 BOTTLE, DISPENSING in 1 CARTON (59256-001-02) / 15 mL in 1 BOTTLE, DISPENSING2014-11-280000-00-00NoNoCurrent