NDC 0536-3000

Ear Wax Treatment

Carbamide Peroxide

Ear Wax Treatment is a Auricular (otic) Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories Inc.. The primary component is Carbamide Peroxide.

Product ID0536-3000_a5201162-9f58-4d51-8318-68ffd474d961
NDC0536-3000
Product TypeHuman Otc Drug
Proprietary NameEar Wax Treatment
Generic NameCarbamide Peroxide
Dosage FormSolution/ Drops
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2009-10-26
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart344
Labeler NameRugby Laboratories Inc.
Substance NameCARBAMIDE PEROXIDE
Active Ingredient Strength82 mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0536-3000-94

15 mL in 1 BOTTLE (0536-3000-94)
Marketing Start Date2009-10-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-3000-94 [00536300094]

Ear Wax Treatment SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart344
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2009-10-26
Marketing End Date2018-05-31

Drug Details

Active Ingredients

IngredientStrength
CARBAMIDE PEROXIDE81.86 mg/mL

OpenFDA Data

SPL SET ID:b31d2529-c7a3-46fc-8e93-f69515a8934b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 702050
  • NDC Crossover Matching brand name "Ear Wax Treatment" or generic name "Carbamide Peroxide"

    NDCBrand NameGeneric Name
    0536-3000Ear Wax TreatmentCarbamide Peroxide
    21695-334Ear Wax TreatmentCarbamide Peroxide
    53145-311AuralytCarbamide Peroxide
    13709-230ClearCanal Ear Wax Softerner DropsCarbamide Peroxide
    0295-1231DEBROXCarbamide Peroxide
    50090-4201DEBROXCarbamide Peroxide
    53943-838Discount Drug Mart Earwax Removal DropsCARBAMIDE PEROXIDE
    53943-835DISCOUNT drug mart FOOD FAIR earwax removal kitCARBAMIDE PEROXIDE
    47649-9001Dr. Whitiss (8.3%)CARBAMIDE PEROXIDE
    47649-0101Dr.Whitiss 10%CARBAMIDE PEROXIDE
    47649-1101Dr.Whitiss 15%CARBAMIDE PEROXIDE
    47649-1201Dr.Whitiss 20%CARBAMIDE PEROXIDE
    47649-1301Dr.Whitiss 35%CARBAMIDE PEROXIDE
    24385-955Ear DropsCarbamide Peroxide
    49794-003Ear Wax Removal AidCarbamide Peroxide
    11673-793Ear Wax Removal Aid DropsCarbamide peroxide
    21130-793Ear Wax Removal Aid DropsCarbamide peroxide
    41250-835Earwax Removal KitCARBAMIDE PEROXIDE
    41163-835Equaline Earwax Removal DropsCARBAMIDE PEROXIDE
    55319-835Family Wellness Earwax Removal Earwax and BulbCARBAMIDE PEROXIDE
    0295-1226Gly-OxideCarbamide Peroxide
    24385-503Good Neighbor Pharmacy Ear SystemCarbamide Peroxide
    46122-556Good Neighbor Pharmacy Earwax RemovalCARBAMIDE PEROXIDE
    46122-557Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDE
    41250-282Meijer Earwax Removal DropsCARBAMIDE PEROXIDE
    0295-7362Murine EarCarbamide peroxide
    50090-3895Murine EarCarbamide peroxide
    13709-314NeilMed Clear Canal Earwax Removal kitCarbamide peroxide
    15579-838Otix Ear wax Removal DropsCARBAMIDE PEROXIDE
    15579-839Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDE
    55910-835Rexall Earwax RemovalCARBAMIDE PEROXIDE
    36800-835TopCare Earwax Removal KitCARBAMIDE PEROXIDE

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