TopCare Earwax Removal Kit

Product NDC
36800-835
11-digit product format
368000835
Labeler code
36800
Product ID
36800-835_2f394074-9ba2-6dff-e063-6294a90a2cad
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
TOPCO ASSOCIATES LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-28
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 Kit
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE65 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-835-33TopCare Earwax Removal Kit15 mL in 1 BOTTLE, DISPENSINGLIQUID157
36800-835-33TopCare Earwax Removal Kit1 in 1 CARTONLIQUID17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-835-33ML - Milliliter36800-835c6604b8b-8d42-4593-a469-d9232c2d0c2f12020-04-20

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-835TOPCARE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 2 package rows20250303_890cc9b6-41a5-480a-bc94-45c8d4fdeef3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN890cc9b6-41a5-480a-bc94-45c8d4fdeef37
702050carbamide peroxide 65 MG/ML Otic SolutionSCD890cc9b6-41a5-480a-bc94-45c8d4fdeef37
702050carbamide peroxide 6.5 % Otic SolutionSY890cc9b6-41a5-480a-bc94-45c8d4fdeef37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-835-33368000835331 BOTTLE, DISPENSING in 1 CARTON (36800-835-33) / 15 mL in 1 BOTTLE, DISPENSING2014-11-280000-00-00NoNoCurrent