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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
application number: M014
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
application number: M014
ndc (product): 11822-1222
Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.15868798-28cd-4495-9baf-711e81ad8bdd2023-12-14WarningsExact identifier
application number: M014
Otix Ear wax Removal DropsCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.0e70ab09-9360-4ab6-a1fe-6f82af3925812023-12-14WarningsExact identifier
application number: M014
TopCare Earwax Removal DropsCARBAMIDE PEROXIDETopco Associates LLCc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2023-12-14WarningsExact identifier
application number: M014
DG Health Earwax Removal kitCARBAMIDE PEROXIDE 6.5%DOLLAR GENERAL CORPORATION4b6fc00f-72d7-4675-9881-b763f27c06e32023-12-07WarningsExact identifier
application number: M014
Ear Wax Removal Drops EquateCARBAMIDE PEROXIDE - 6.5%WALMART STORES INC33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d2023-12-04WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEProficient Rx LPa131447b-a5a0-45cd-a59c-a9f719275baa2023-12-01WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact 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