NDC 47649-1301

Dr.Whitiss 35%

Carbamide Peroxide

Dr.Whitiss 35% 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 ID47649-1301_7dfa691f-3a41-82c1-e053-2a91aa0a3be8
NDC47649-1301
Product TypeHuman Otc Drug
Proprietary NameDr.Whitiss 35%
Generic NameCarbamide Peroxide
Dosage FormGel, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2015-08-11
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameNibec Co., Ltd
Substance NameCARBAMIDE PEROXIDE
Active Ingredient Strength35 g/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 47649-1301-2

4 SYRINGE in 1 PACKAGE (47649-1301-2) > 1 g in 1 SYRINGE (47649-1301-1)
Marketing Start Date2015-08-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47649-1301-2 [47649130102]

Dr.Whitiss 35% GEL, DENTIFRICE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-11

NDC 47649-1301-1 [47649130101]

Dr.Whitiss 35% GEL, DENTIFRICE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-11

Drug Details

Active Ingredients

IngredientStrength
CARBAMIDE PEROXIDE35 g/100g

OpenFDA Data

SPL SET ID:9ccab937-213d-45a2-8bf7-2aa9666fc1d9
Manufacturer
UNII

NDC Crossover Matching brand name "Dr.Whitiss 35%" or generic name "Carbamide Peroxide"

NDCBrand NameGeneric Name
47649-1301Dr.Whitiss 35%CARBAMIDE 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
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
55910-835Rexall Earwax RemovalCARBAMIDE PEROXIDE
36800-835TopCare Earwax Removal KitCARBAMIDE PEROXIDE
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