Wax Away Earwax Removal System

Product NDC
66354-006
11-digit product format
663540006
Labeler code
66354
Product ID
66354-006_4a637950-a5e8-70d1-e063-6294a90acb51
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
McKeon Products Inc
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-05
Substance
CARBAMIDE PEROXIDE
Active strength
65 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Wax Away Earwax Removal System
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE65 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66354-006-80Wax Away Earwax Removal System1 in 1 BOXSOLUTION/ DROPS11
66354-006-80Wax Away Earwax Removal System15 mL in 1 BOTTLESOLUTION/ DROPS151

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN22c6f7db-814b-4e70-9fbe-bbb86385d0701
702050carbamide peroxide 65 MG/ML Otic SolutionSCD22c6f7db-814b-4e70-9fbe-bbb86385d0701
702050carbamide peroxide 6.5 % Otic SolutionSY22c6f7db-814b-4e70-9fbe-bbb86385d0701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66354-006-80663540006801 BOTTLE in 1 BOX (66354-006-80) / 15 mL in 1 BOTTLE1 bottle2026-02-05NoNoHistorical