FDA.reportPublic FDA data

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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31PZ2VAU81Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702050Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
890cc9b6-41a5-480a-bc94-45c8d4fdeef3Available on FDA.report

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU81TOPCARE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [TOPCO ASSOCIATES LLC]3
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VTOPCARE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [TOPCO ASSOCIATES LLC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTOPCARE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [TOPCO ASSOCIATES LLC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCARE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [TOPCO ASSOCIATES LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TOPCARE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [TOPCO ASSOCIATES LLC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTOPCARE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [TOPCO ASSOCIATES LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTOPCARE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [TOPCO ASSOCIATES LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [TOPCO ASSOCIATES LLC]3

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HANCHOBIT Lemon Turmeric Kojic Acid BrighteningGLYCERINHANCHOYEANBIOTEC Co.,Ltd.2ded8f31-d72a-d123-e063-6294a90a28562025-11-27WarningsExact identifier
application number: M014
XIMONTH Wart RemoverGLYCERINShantou Ximonth Biotechnology Co., Ltd.337d4d37-c2d6-44d3-e063-6294a90a77ce2025-11-26WarningsExact identifier
application number: M014
Swimmers EarCLEARCANALNeilmed Pharmaceuticals Inc.43778b02-e90b-36b7-e063-6394a90ab62b2025-11-13WarningsExact identifier
application number: M014
Hand SanitizerALCOHOLCharlotte Products Ltd.1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa2025-10-28WarningsExact identifier
application number: M014
Carbamide peroxide 6.5%EARWAX REMOVAL KITAllegiant Health54515e9d-2225-4875-a1cf-a24a823300dd2025-10-28WarningsExact identifier
application number: M014
OFTAL-MYCIN LUBRICANT OPHTHALMICLIGHT MINERAL, WHITE PETROLATUMGRANDALL DISTRIBUTING, LLC298db04a-21a9-e46e-e063-6294a90acee22025-10-27WarningsExact identifier
application number: M014
Debrox Swimmers EarISOPROPYL ALCOHOLMedtech Products Inc.b5d57c7b-8315-4260-967e-38fdd54e2a9c2025-10-23WarningsExact identifier
application number: M014
Family Care Earwax RemovalCARBAMIDE PEROXIDEUnited Exchange Corp.958741f5-47c1-339c-e053-2a95a90a3f5f2025-10-22WarningsExact identifier
application number: M014
GoodSense Ear Wax Removal KitCARBAMIDE PEROXIDEGeiss, Destin & Dunn, Inc31ea324f-a9a1-7865-e063-6294a90a92e82025-09-19WarningsExact identifier
application number: M014
blue goo NERVE EASE Pain RELIEF Topical AnalgesicLIDOCAINE HCL 4%, MENTHOL 1%Garcoa, Inc.619d5c87-636c-407d-909e-c38512dcd5532025-09-10WarningsExact identifier
application number: M014
DEBROXCARBAMIDE PEROXIDEA-S Medication Solutions8d6f1769-eb44-4bde-b3fa-3ff4658b7dd12025-09-03WarningsExact identifier
application number: M014
AuralytCARBAMIDE PEROXIDEMenper Distributors, Inc95920b87-941f-48cb-850c-40d2735596d42025-07-22WarningsExact identifier
application number: M014
hydrocortisoneHYDROCORTISONENuCare Pharmaceuticals,Inc.a0fde5c9-afb2-76a9-e053-2995a90af3e82025-07-21WarningsExact identifier
application number: M014
Healthy EarsCARBIDE PEROXIDEVitamex USA, Corp25953441-cd8e-5038-e063-6294a90ae4012025-06-23WarningsExact identifier
application number: M014
WaxRx Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEDOCTOR EASY MEDICAL PRODUCTS, LLC7e08cd86-7ae4-7d12-e053-2991aa0a4cba2025-05-01WarningsExact identifier
application number: M014
Meijer Earwax Removal DropsCARBAMIDE PEROXIDEMeijer Distribution Inc900108c6-0324-644a-e053-2a95a90a3b2b2025-02-28WarningsExact identifier
application number: M014
Tech Care Earwax Removal KitCARBAMIDE PEROXIDEWarner Tech-care Products, LLC5851c1f6-c15b-447c-b495-3707e7a12bdb2025-02-28WarningsExact identifier
application number: M014
Tech Care Earwax Removal DropsCARBAMIDE PEROXIDEWarner Tech-care Products, LLC1c97783b-dcdf-4f95-8516-0d7f197cbc272025-02-28WarningsExact identifier
application number: M014
TopCare Earwax Removal KitCARBAMIDE PEROXIDETOPCO ASSOCIATES LLC890cc9b6-41a5-480a-bc94-45c8d4fdeef32025-02-28WarningsExact identifier
application number: M014
ndc (product): 36800-835
Audiologists Choice Earwax Removal Aid DropsCARBAMIDE PEROXIDEOaktree Products Inc2922dde2-d082-437b-8f51-4a91ced20a582025-02-28WarningsExact identifier
application number: M014

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