Earwax Removal Drops

Product NDC
82645-910
11-digit product format
826450910
Labeler code
82645
Product ID
82645-910_0d1cdfd7-c2cf-9fd5-e063-6394a90a8eda
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide 6.5%
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Pharma Nobis, LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-04
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
82645-910-45Earwax Removal Drops15 mL in 1 BOTTLE, DROPPERLIQUID153
82645-910-45Earwax Removal Drops1 in 1 CARTONLIQUID13
82645-910-90Earwax Removal Drops15 mL in 1 CONTAINERLIQUID153
82645-910-90Earwax Removal Drops1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-910EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [PHARMA NOBIS, LLC]3Current NDC, Legacy NDC, 4 package rows20231223_e21e114c-99b6-861c-e053-2995a90aeac1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82645-910-45826450910451 BOTTLE, DROPPER in 1 CARTON (82645-910-45) / 15 mL in 1 BOTTLE, DROPPER2019-06-040000-00-00NoNoCurrent
82645-910-90826450910901 CONTAINER in 1 CARTON (82645-910-90) / 15 mL in 1 CONTAINER1 container2019-06-040000-00-00NoNoCurrent