Earwax Removal Drops

Product NDC
52412-600
11-digit product format
524120600
Labeler code
52412
Product ID
52412-600_0ce5bdec-f500-73d9-e063-6294a90a6a87
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide 6.5%
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Randob Labs, Ltd.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-03
Substance
CARBAMIDE PEROXIDE
Active strength
.065 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
Earwax Removal Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE.065 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-600-05Earwax Removal Drops15 mL in 1 BOTTLE, DROPPERLIQUID154
52412-600-05Earwax Removal Drops1 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-600EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [RANDOB LABS, LTD.]4Current NDC, Legacy NDC, 2 package rows20231220_a9904b63-27a4-205c-e053-2995a90af762.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52412-600-05524120600051 BOTTLE, DROPPER in 1 CARTON (52412-600-05) / 15 mL in 1 BOTTLE, DROPPER2020-07-030000-00-00NoNoCurrent