FDA.reportPublic FDA data

Meijer Earwax Removal Kit

Product NDC
41250-835
11-digit product format
412500835
Labeler code
41250
Product ID
41250-835_52f6676c-1f3c-0643-e063-6294a90a7995
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Meijer Distribution Inc.
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Meijer Earwax Removal Kit
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
a5f7bd55-55c3-4b0e-a16c-33bbea40536aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-835-33Meijer Earwax Removal Kit1 in 1 CARTONLIQUID14
41250-835-33Meijer Earwax Removal Kit15 mL in 1 BOTTLE, DISPENSINGLIQUID154

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU81EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [MEIJER DISTRIBUTION INC.]2
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VEARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [MEIJER DISTRIBUTION INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLEARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [MEIJER DISTRIBUTION INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [MEIJER DISTRIBUTION INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [MEIJER DISTRIBUTION INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULREARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [MEIJER DISTRIBUTION INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [MEIJER DISTRIBUTION INC.]2
WATERINACTIVE INGREDIENT059QF0KO0REARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [MEIJER DISTRIBUTION INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-835MEIJER EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [MEIJER DISTRIBUTION INC.]4Current NDC, Legacy NDC, 2 package rows20231215_a5f7bd55-55c3-4b0e-a16c-33bbea40536a.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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
application number: M014
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
application number: M014
Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.15868798-28cd-4495-9baf-711e81ad8bdd2023-12-14WarningsExact identifier
application number: M014
Otix Ear wax Removal DropsCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.0e70ab09-9360-4ab6-a1fe-6f82af3925812023-12-14WarningsExact identifier
application number: M014
TopCare Earwax Removal DropsCARBAMIDE PEROXIDETopco Associates LLCc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2023-12-14WarningsExact identifier
application number: M014
DG Health Earwax Removal kitCARBAMIDE PEROXIDE 6.5%DOLLAR GENERAL CORPORATION4b6fc00f-72d7-4675-9881-b763f27c06e32023-12-07WarningsExact identifier
application number: M014
Ear Wax Removal Drops EquateCARBAMIDE PEROXIDE - 6.5%WALMART STORES INC33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d2023-12-04WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEProficient Rx LPa131447b-a5a0-45cd-a59c-a9f719275baa2023-12-01WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNa5f7bd55-55c3-4b0e-a16c-33bbea40536a5
702050carbamide peroxide 65 MG/ML Otic SolutionSCDa5f7bd55-55c3-4b0e-a16c-33bbea40536a5
702050carbamide peroxide 6.5 % Otic SolutionSYa5f7bd55-55c3-4b0e-a16c-33bbea40536a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41250-835-33412500835331 BOTTLE, DISPENSING in 1 CARTON (41250-835-33) / 15 mL in 1 BOTTLE, DISPENSING2014-11-270000-00-00NoNoCurrent