ERO Ear Wax Removal Kit

Product NDC
52412-175
11-digit product format
524120175
Labeler code
52412
Product ID
52412-175_29575528-5bed-065e-e063-6394a90a4eca
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide 6.5%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Randob Labs
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-16
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
ERO Ear Wax Removal Kit
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-175-01ERO Ear Wax Removal Kit1 in 1 CARTONLIQUID12
52412-175-01ERO Ear Wax Removal Kit15 mL in 1 BOTTLELIQUID152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-175ERO EAR WAX REMOVAL KIT (CARBAMIDE PEROXIDE 6.5%) LIQUID [RANDOB LABS]2Current NDC, 2 package rows20241217_fbf8a6f2-531d-5047-e053-6294a90aaa01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNfbf8a6f2-531d-5047-e053-6294a90aaa012
702050carbamide peroxide 65 MG/ML Otic SolutionSCDfbf8a6f2-531d-5047-e053-6294a90aaa012
702050carbamide peroxide 6.5 % Otic SolutionSYfbf8a6f2-531d-5047-e053-6294a90aaa012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52412-175-01524120175011 BOTTLE in 1 CARTON (52412-175-01) / 15 mL in 1 BOTTLE1 bottle2021-04-16NoNoHistorical