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

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 Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

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

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