FDA.reportPublic FDA data

Major Earwax Removal Drops Earwax Removal Aid

Product NDC
0904-7478
11-digit product format
009047478
Labeler code
0904
Product ID
0904-7478_1f7fbab4-f5a2-0187-e063-6394a90afba1
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
Major Pharmaceuticals
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-09
Substance
CARBAMIDE PEROXIDE
Active strength
65 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Major Earwax Removal Drops Earwax Removal Aid
Listing expiration
2026-12-31

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
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7478-35Major Earwax Removal Drops Earwax Removal Aid1 in 1 BOXSOLUTION/ DROPS12
0904-7478-35Major Earwax Removal Drops Earwax Removal Aid15 mL in 1 BOTTLESOLUTION/ DROPS152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7478-35ML - Milliliter0904-7478968d4300-7bf9-423a-b474-cb7dedfaf61f12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7478MAJOR EARWAX REMOVAL DROPS EARWAX REMOVAL AID (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [MAJOR PHARMACEUTICALS]2Current NDC, 2 package rows20240814_513bf82e-a36f-49d0-ba74-c834fea4f3b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN513bf82e-a36f-49d0-ba74-c834fea4f3b52
702050carbamide peroxide 65 MG/ML Otic SolutionSCD513bf82e-a36f-49d0-ba74-c834fea4f3b52
702050carbamide peroxide 6.5 % Otic SolutionSY513bf82e-a36f-49d0-ba74-c834fea4f3b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7478-35009047478351 BOTTLE in 1 BOX (0904-7478-35) / 15 mL in 1 BOTTLE1 bottle2024-07-09NoNoCurrent