TopCare Earwax Removal Drops

Product NDC
76162-836
11-digit product format
761620836
Labeler code
76162
Product ID
76162-836_0c7ffed4-7f2b-0946-e063-6394a90aef39
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Topco Associates LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-01
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
TopCare Earwax Removal Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE65 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-836-34TopCare Earwax Removal Drops15 mL in 1 BOTTLESOLUTION/ DROPS152
76162-836-34TopCare Earwax Removal Drops1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-836TOPCARE EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 2 package rows20231219_c5b1ad0e-3712-40fd-afbe-54c0b5f1160b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2
702050carbamide peroxide 65 MG/ML Otic SolutionSCDc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2
702050carbamide peroxide 6.5 % Otic SolutionSYc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76162-836-34761620836341 BOTTLE in 1 BOX (76162-836-34) / 15 mL in 1 BOTTLE1 bottle2015-06-010000-00-00NoNoCurrent