FDA.reportPublic FDA data

EarWax Removal Kit

Product NDC
11822-1222
11-digit product format
118221222
Labeler code
11822
Product ID
11822-1222_0c93ce87-317a-1617-e063-6394a90a618d
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide 6.5%
Dosage form
KIT
Labeler
Rite Aid
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-10-04
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
EarWax Removal Kit
Brand name suffix
Rite Aid
Listing expiration
2027-12-31

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
da78ac58-6c1c-4fa9-baac-e9dec0241385Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-1222-72020-02-10C16284748780-19d75b9cf-fa1f-f424-e053-dadaa90a57ceRite Aid Earwax Kit
11822-1222-72020-01-31C16284748780-19d75b9cf-fa1f-f424-e053-dadaa90a57ceRite Aid Earwax Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1222-7EarWax Removal KitRite Aid1 in 1 KITKIT15
11822-1224-1EarWax Removal KitRite Aid15 mL in 1 BOTTLELIQUID15 mL6.5 g in 100mL5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1222EARWAX REMOVAL KIT RITE AID (CARBAMIDE PEROXIDE 6.5%) KIT [RITE AID]5Current NDC, Legacy NDC, 2 package rows20231216_da78ac58-6c1c-4fa9-baac-e9dec0241385.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNda78ac58-6c1c-4fa9-baac-e9dec02413855
702050carbamide peroxide 65 MG/ML Otic SolutionSCDda78ac58-6c1c-4fa9-baac-e9dec02413855
702050carbamide peroxide 6.5 % Otic SolutionSYda78ac58-6c1c-4fa9-baac-e9dec02413855

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1222-7118221222071 KIT in 1 KIT (11822-1222-7) * 15 mL in 1 BOTTLE (11822-1224-1) 1 kit2011-10-040000-00-00NoNoCurrent
11822-1224-11182212240115 mL in 1 BOTTLE15 mlHistorical