FDA.reportPublic FDA data

GoodSense Ear Wax Removal Kit

Product NDC
50804-117
11-digit product format
508040117
Labeler code
50804
Product ID
50804-117_3f2f88ef-2715-ebff-e063-6394a90ae84a
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Geiss, Destin & Dunn, Inc
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
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
GoodSense Ear Wax Removal Kit
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
31ea324f-a9a1-7865-e063-6294a90a92e8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-117-01GoodSense Ear Wax Removal Kit15 mL in 1 BOTTLELIQUID152
50804-117-01GoodSense Ear Wax Removal Kit1 in 1 BOXLIQUID12
50804-117-11GoodSense Ear Wax Removal Kit1 in 1 BOXLIQUID12
50804-117-11GoodSense Ear Wax Removal Kit15 mL in 1 BOTTLELIQUID152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-117-01ML - Milliliter50804-1173c49e2f7-e3fa-4e91-8bf9-8ec43040d16712025-07-08
50804-117-11ML - Milliliter50804-117fa69c67c-3f91-4adb-8dbe-07d654205c9812026-02-05

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 SolutionPSN31ea324f-a9a1-7865-e063-6294a90a92e82
702050carbamide peroxide 65 MG/ML Otic SolutionSCD31ea324f-a9a1-7865-e063-6294a90a92e82
702050carbamide peroxide 6.5 % Otic SolutionSY31ea324f-a9a1-7865-e063-6294a90a92e82
702050carbamide peroxide 6.5 % Otic SolutionPSN9a4198d2-cbea-466a-a252-d5c63d9ea0c11
702050carbamide peroxide 65 MG/ML Otic SolutionSCD9a4198d2-cbea-466a-a252-d5c63d9ea0c11
702050carbamide peroxide 6.5 % Otic SolutionSY9a4198d2-cbea-466a-a252-d5c63d9ea0c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50804-117-01508040117011 BOTTLE in 1 BOX (50804-117-01) / 15 mL in 1 BOTTLE1 bottle2025-05-01NoNoCurrent
50804-117-11508040117111 BOTTLE in 1 BOX (50804-117-11) / 15 mL in 1 BOTTLE1 bottle2025-05-01NoNoCurrent