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 5 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraSealDIMETHICONEBausch Health US, LLC2c8dc616-20c1-4d33-8a89-9bcdb22b35c82024-10-17WarningsExact identifier
application number: M014
fungoid tinctureMICONAZOLE NITRATEPedinol Pharmacal, Inc.250d0a66-01d1-4aba-8f24-4cb4ca529fda2024-10-17WarningsExact identifier
application number: M014
GenRx Anti-Bacterial GelALCOHOLPureTek Corporationa124e37e-1a44-212a-e053-2995a90a0af02024-10-01WarningsExact identifier
application number: M014
Hand Sanitizing with Lavender OilALCOHOLPureTek Corporationa75d25a7-1e23-717f-e053-2a95a90a6d932024-10-01WarningsExact identifier
application number: M014
Leader Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDECardinal Health, Inc.0022a174-8377-44af-84a9-31adb27de1312024-08-23WarningsExact identifier
application number: M014
Leader Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDECardinal Health 110 DBA Leader36c1408b-4287-4e9f-aa17-4f05add500382024-08-12WarningsExact identifier
application number: M014
Major Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDEMajor Pharmaceuticals513bf82e-a36f-49d0-ba74-c834fea4f3b52024-08-12WarningsExact identifier
application number: M014
Alcohol WipesWIPE EM ALCOHOL WIPESShaoxing Elite Bio-Tech Co., Ltd.1f373096-d3d5-af7f-e063-6394a90a3b552024-08-08WarningsExact identifier
application number: M014
Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDENuCare Pharmaceuticals,Inc.b55acec6-5a4d-08b7-e053-2995a90a0f742024-07-17WarningsExact identifier
application number: M014
BacitracinBACITRACINNuCare Pharmaceuticals,Inc.a526ae4b-baae-5d50-e053-2a95a90ae2932024-07-17WarningsExact identifier
application number: M014
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals, Inc.54241254-1d9a-346a-e054-00144ff8d46c2024-07-17WarningsExact identifier
application number: M014
Dr Sheffield Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals,Inc.5786a559-a387-120d-e053-2991aa0ab6472024-07-15WarningsExact identifier
application number: M014
CVS Health Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDECVS Pharmacy, Inc.42a22e06-1b66-4359-852c-7c39e1b3940a2024-06-24WarningsExact identifier
application number: M014
TolnaftateTOLNAFTATENuCare Pharmaceuticals,Inc.63665de7-8415-651f-e053-2991aa0ac2bb2024-06-06WarningsExact identifier
application number: M014
Rite Aid Earwax Removal DropsCARBAMIDE PEROXIDERite Aid1262531e-0674-cf32-e063-6294a90a0d0b2024-05-10WarningsExact identifier
application number: M014
Debrox KidsISOPROPYL ALCOHOLMedtech Products Inc.f42eee70-c4ee-44ad-85d5-a06d98ecb8b02024-05-09WarningsExact identifier
application number: M014
Rite Aid Swimmers Ear DropsISOPROPYL ALCOHOLRite Aid12875b9d-3ae8-bd0c-e063-6294a90ab4ae2024-02-29WarningsExact identifier
application number: M014
Topcare Swimmers Ear DropsISOPROPYL ALCOHOLTopco Associates LLC0fddeb43-fee0-d43c-e063-6394a90a738a2024-01-26WarningsExact identifier
application number: M014
NeilMed Clear Canal Earwax Removal kitCARBAMIDE PEROXIDENEILMED PHARMACEUTICALS INCd330552d-07b6-f01e-e053-2a95a90a7ca52024-01-11WarningsExact identifier
application number: M014
Wax Out PlusCARBAMIDE PEROXIDE DROPSNEILMED PHARMACEUTICALS INCcf64f4b8-279c-8c1d-e053-2995a90ac8532024-01-11WarningsExact 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