NDC 0904-6627

Ear Drops Major

Carbamide Peroxide 6.5%

Ear Drops Major is a Auricular (otic) Liquid in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Carbamide Peroxide.

Product ID0904-6627_584401f6-642f-403f-90ce-acdd7b120799
NDC0904-6627
Product TypeHuman Otc Drug
Proprietary NameEar Drops Major
Generic NameCarbamide Peroxide 6.5%
Dosage FormLiquid
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2017-02-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart344
Labeler NameMajor Pharmaceuticals
Substance NameCARBAMIDE PEROXIDE
Active Ingredient Strength7 g/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0904-6627-35

1 BOTTLE in 1 CARTON (0904-6627-35) > 15 mL in 1 BOTTLE
Marketing Start Date2019-10-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6627-35 [00904662735]

Ear Drops Major LIQUID
Marketing CategoryOTC monograph final
Application Numberpart344
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-10-10

Drug Details

Active Ingredients

IngredientStrength
CARBAMIDE PEROXIDE6.5 g/100mL

OpenFDA Data

SPL SET ID:ad8bce05-6be4-4f6c-9341-bce7c3aa05cf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 702050
    • UPC Code
  • 0309046627357

    • NDC Crossover Matching brand name "Ear Drops Major" or generic name "Carbamide Peroxide 6.5%"

    NDCBrand NameGeneric Name
    0904-6627Ear DropsCarbamide Peroxide 6.5%
    50090-5273Ear DropsCarbamide Peroxide 6.5%
    50804-508Ear DropsCarbamide Peroxide 6.5%
    69452-377ear dropsCarbamide Peroxide 6.5%
    69842-097Ear DropsCarbamide Peroxide 6.5%
    70518-0524Ear DropsCarbamide Peroxide 6.5%
    68071-2568Ear Drops (Carbamide Peroxide 6.5%)Carbamide Peroxide 6.5%
    59779-486Ear Drops Earwax Removal AidCarbamide Peroxide 6.5%
    11822-1224EAR WAX RMVLCarbamide Peroxide 6.5%
    69842-039EAR WAX RMVLCarbamide Peroxide 6.5%
    0395-9132Earwax Removal DropsCarbamide Peroxide 6.5%
    0395-9133Earwax Removal DropsCarbamide Peroxide 6.5%
    24385-502Earwax Removal DropsCarbamide Peroxide 6.5%
    41520-351Earwax Removal DropsCarbamide Peroxide 6.5%
    49035-537Earwax Removal DropsCarbamide Peroxide 6.5%
    52412-600Earwax Removal DropsCarbamide Peroxide 6.5%
    68016-271Earwax Removal DropsCarbamide Peroxide 6.5%
    69842-096Earwax Removal DropsCarbamide Peroxide 6.5%
    82645-910Earwax Removal DropsCarbamide Peroxide 6.5%
    11822-1222EarWax Removal KitCarbamide Peroxide 6.5%
    69842-224EarWax Removal KitCarbamide Peroxide 6.5%
    0536-1124Earwax Treatment DropsCarbamide Peroxide 6.5%
    50090-2941Earwax Treatment DropsCarbamide Peroxide 6.5%
    68788-7256Earwax Treatment DropsCarbamide Peroxide 6.5%
    69256-117Harris Teeter Earwax Removal DropsCarbamide Peroxide 6.5%
    0363-2068Walgreens Ear Wax RemoverCarbamide Peroxide 6.5%

    Trademark Results [Ear Drops]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EAR DROPS
    EAR DROPS
    78972782 3396558 Dead/Cancelled
    Matsushita Electric Industrial Co., Ltd.
    2006-09-12
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.