FDA.reportPublic FDA data

Harris Teeter Earwax Removal Drops

Product NDC
69256-117
11-digit product format
692560117
Labeler code
69256
Product ID
69256-117_2958cebe-650c-ea65-e063-6394a90a3f39
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide 6.5%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Harris Teeter LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-27
Substance
CARBAMIDE PEROXIDE
Active strength
6.5 g/100mL
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
Harris Teeter Earwax Removal Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE6.5 g/100mL

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
dda4c4bf-425e-4fff-e053-2a95a90a51bcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69256-117-01Harris Teeter Earwax Removal Drops15 mL in 1 BOTTLELIQUID152
69256-117-01Harris Teeter Earwax Removal Drops1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69256-117HARRIS TEETER EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [HARRIS TEETER LLC]2Current NDC, Legacy NDC, 2 package rows20241217_dda4c4bf-425e-4fff-e053-2a95a90a51bc.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
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 SolutionPSNdda4c4bf-425e-4fff-e053-2a95a90a51bc2
702050carbamide peroxide 65 MG/ML Otic SolutionSCDdda4c4bf-425e-4fff-e053-2a95a90a51bc2
702050carbamide peroxide 6.5 % Otic SolutionSYdda4c4bf-425e-4fff-e053-2a95a90a51bc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69256-117-01692560117011 BOTTLE in 1 CARTON (69256-117-01) / 15 mL in 1 BOTTLE1 bottle2022-04-270000-00-00NoNoCurrent