NDC 47649-1101

Dr.Whitiss 15%

Carbamide Peroxide

Dr.Whitiss 15% is a Dental Gel, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Nibec Co., Ltd. The primary component is Carbamide Peroxide.

Product ID47649-1101_7dfa691f-3a2b-82c1-e053-2a91aa0a3be8
NDC47649-1101
Product TypeHuman Otc Drug
Proprietary NameDr.Whitiss 15%
Generic NameCarbamide Peroxide
Dosage FormGel, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2015-06-07
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameNibec Co., Ltd
Substance NameCARBAMIDE PEROXIDE
Active Ingredient Strength15 g/100g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 47649-1101-2

4 SYRINGE in 1 PACKAGE (47649-1101-2) > 1 g in 1 SYRINGE (47649-1101-1)
Marketing Start Date2015-06-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47649-1101-1 [47649110101]

Dr.Whitiss 15% GEL, DENTIFRICE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-06-07
Marketing End Date2015-06-07

NDC 47649-1101-2 [47649110102]

Dr.Whitiss 15% GEL, DENTIFRICE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-06-07
Marketing End Date2015-06-07

Drug Details

Active Ingredients

IngredientStrength
CARBAMIDE PEROXIDE15 g/100g

OpenFDA Data

SPL SET ID:410957b0-98bd-4dab-b660-ba0d4803cef6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1653115
  • NDC Crossover Matching brand name "Dr.Whitiss 15%" or generic name "Carbamide Peroxide"

    NDCBrand NameGeneric Name
    47649-1101Dr.Whitiss 15%CARBAMIDE PEROXIDE
    47649-1102Dr.Whitiss 15%CARBAMIDE PEROXIDE, SODIUM FLUORIDE
    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
    47649-1201Dr.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
    0536-3000Ear Wax TreatmentCarbamide Peroxide
    21695-334Ear Wax TreatmentCarbamide 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
    36800-835TopCare Earwax Removal KitCARBAMIDE PEROXIDE

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