FDA.reportPublic FDA data

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

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
Earwax Removal Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE.065 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e21e114c-99b6-861c-e053-2995a90aeac1Available on FDA.report

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

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
Audiologists Choice Earwax Removal Aid DropsCARBAMIDE PEROXIDEOaktree Products Inc2922dde2-d082-437b-8f51-4a91ced20a582025-02-28WarningsExact identifier
application number: M014

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