FDA.reportPublic FDA data

Audiologists Choice Earwax Removal System

Product NDC
59256-001
Requested package NDC
59256-001-02
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 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702050Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9ad507b-341c-474f-aaa2-3c3a97a30dd8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-03-18AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM
2020-03-18AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM
2020-01-31AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM
2020-01-31AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU81AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM EARWAX REMOVAL (CARBAMIDE PEROXIDE) LIQUID [OAKTREE PRODUCTS INC.]2
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VAUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM EARWAX REMOVAL (CARBAMIDE PEROXIDE) LIQUID [OAKTREE PRODUCTS INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM EARWAX REMOVAL (CARBAMIDE PEROXIDE) LIQUID [OAKTREE PRODUCTS INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM EARWAX REMOVAL (CARBAMIDE PEROXIDE) LIQUID [OAKTREE PRODUCTS INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM EARWAX REMOVAL (CARBAMIDE PEROXIDE) LIQUID [OAKTREE PRODUCTS INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM EARWAX REMOVAL (CARBAMIDE PEROXIDE) LIQUID [OAKTREE PRODUCTS INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM EARWAX REMOVAL (CARBAMIDE PEROXIDE) LIQUID [OAKTREE PRODUCTS INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RAUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM EARWAX REMOVAL (CARBAMIDE PEROXIDE) LIQUID [OAKTREE PRODUCTS INC.]2

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

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 1 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC54dc3642-0b7a-07d8-e063-6294a90ad5562026-07-22WarningsExact identifier
application number: M014
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC55057e1b-b11e-51b9-e063-6394a90a9fca2026-07-22WarningsExact identifier
application number: M014
Macks Dry n ClearEAR DRYING AIDMcKeon Products Inc1ea1da54-2412-c25c-e063-6294a90aa2642026-06-26WarningsExact identifier
application number: M014
Equate Swimmers Instant Ear DryEQUATE SWIMMERS INSTANT EAR DRYWalmart Stores, Inc76b58a7a-48cf-866c-e053-2a91aa0a7e632026-06-26WarningsExact identifier
application number: M014
Quality Choice Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.c68b40d9-c1d4-4425-8063-50c00299e7182026-06-10WarningsExact identifier
application number: M014
Quality Choice Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.b2a641da-e070-4223-b836-5ca9ffb89f3f2026-06-10WarningsExact identifier
application number: M014
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-06-03WarningsExact identifier
application number: M014
Audiologists Choice Earwax Removal SystemCARBAMIDE PEROXIDEOaktree Products Inc.c9ad507b-341c-474f-aaa2-3c3a97a30dd82026-05-29WarningsExact identifier
application number: M014
ndc (package): 59256-001-02
ndc (product): 59256-001
ndc11 (package): 59256000102
CVS Health Earwax Removal KitCARBAMIDE PEROXIDECVS Pharmacy, Inc.f842534c-46dd-42c7-8386-9a03ce16da862026-05-29WarningsExact identifier
application number: M014
Lucid Hearing Earwax Removal Kit and BulbCARBAMIDE PEROXIDEHearing Lab Technology LLC5e09f566-397f-44d6-8ba2-90987765c7372026-05-29WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEAmerisource Bergen89eac1b0-c700-45b5-8478-da53ace72e162026-05-29WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax RemovalCARBAMIDE PEROXIDEAmerisource Bergend503b10f-85cd-4bb8-9dec-82d651d525fa2026-05-29WarningsExact identifier
application number: M014
Meijer Earwax Removal KitCARBAMIDE PEROXIDEMeijer Distribution Inc.a5f7bd55-55c3-4b0e-a16c-33bbea40536a2026-05-29WarningsExact identifier
application number: M014
Quality Choice Earwax Removal DropsCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.d8fd8102-114f-415d-9083-f98a63f9d1b32026-05-29WarningsExact identifier
application number: M014
Menthol Pain Relieving GelPAIN RELIEVING GELNeilMed Pharmaceuticals Inc513a206c-bbf6-3e51-e063-6294a90adf7a2026-05-07WarningsExact identifier
application number: M014
ear dropsCARBAMIDE PEROXIDE 6.5%Bionpharma Inc.e8bcf92c-ad32-49d5-e053-2995a90ae0c62026-04-27WarningsExact identifier
application number: M014
Freskaro Earwax Removal AidCARBAMIDE PEROXIDE 6.50% KITPharma Nobis, LLC4f5967ee-bc05-341c-e063-6394a90a35c62026-04-15WarningsExact identifier
application number: M014
GoodSense Ear Wax Removal KitCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.9a4198d2-cbea-466a-a252-d5c63d9ea0c12026-04-09WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.52f733a7-1301-4078-9267-5ce95b006ccc2026-04-09WarningsExact identifier
application number: M014
Walgreens Swimmers EarISOPROPYL ALCOHOLWalgreens Co3fb65a5c-c47f-ef2b-e063-6394a90af21a2026-04-01WarningsExact identifier
application number: M014

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