FDA.reportPublic FDA data

Best Choice Earwax Removal Kit

Product NDC
63941-835
11-digit product format
639410835
Labeler code
63941
Product ID
63941-835_0c868857-d577-9413-e063-6294a90a0bab
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Valu Merchandisers, Co.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-27
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
Best Choice Earwax Removal Kit
Listing expiration
2026-12-31

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
f943ac0e-8171-446d-8c6c-69612b482643Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-835-33Best Choice Earwax Removal Kit15 mL in 1 BOTTLE, DISPENSINGLIQUID153
63941-835-33Best Choice Earwax Removal Kit1 in 1 CARTONLIQUID13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU81BEST CHOICE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [VALU MERCHANDISERS, CO.]1
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VBEST CHOICE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [VALU MERCHANDISERS, CO.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBEST CHOICE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [VALU MERCHANDISERS, CO.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBEST CHOICE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [VALU MERCHANDISERS, CO.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BEST CHOICE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [VALU MERCHANDISERS, CO.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBEST CHOICE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [VALU MERCHANDISERS, CO.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBEST CHOICE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [VALU MERCHANDISERS, CO.]1
WATERINACTIVE INGREDIENT059QF0KO0RBEST CHOICE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [VALU MERCHANDISERS, CO.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-835BEST CHOICE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [VALU MERCHANDISERS, CO.]3Current NDC, Legacy NDC, 2 package rows20231215_f943ac0e-8171-446d-8c6c-69612b482643.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
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 SolutionPSNf943ac0e-8171-446d-8c6c-69612b4826433
702050carbamide peroxide 65 MG/ML Otic SolutionSCDf943ac0e-8171-446d-8c6c-69612b4826433
702050carbamide peroxide 6.5 % Otic SolutionSYf943ac0e-8171-446d-8c6c-69612b4826433

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63941-835-33639410835331 BOTTLE, DISPENSING in 1 CARTON (63941-835-33) / 15 mL in 1 BOTTLE, DISPENSING2014-11-270000-00-00NoNoCurrent