NDC 0295-1231

DEBROX

Carbamide Peroxide

DEBROX is a Auricular (otic) Liquid in the Human Otc Drug category. It is labeled and distributed by Denison Pharmaceuticals, Llc.. The primary component is Carbamide Peroxide.

• Product ID: 0295-1231_d97fd986-9db8-49b7-845e-04b36e383275
• NDC: 0295-1231
• Product Type: Human Otc Drug
• Proprietary Name: DEBROX
• Generic Name: Carbamide Peroxide
• Dosage Form: Liquid
• Route of Administration: AURICULAR (OTIC)
• Marketing Start Date: 2017-01-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part344
• Labeler Name: Denison Pharmaceuticals, LLC.
• Substance Name: CARBAMIDE PEROXIDE
• Active Ingredient Strength: 0 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0295-1231-02

1 BOTTLE, DROPPER in 1 CARTON (0295-1231-02) > 15 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2017-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0295-1231-02 [00295123102]

DEBROX LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part344
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-01-01

Drug Details

Active Ingredients

Ingredient	Strength
CARBAMIDE PEROXIDE	.065 mg/mL

OpenFDA Data

• SPL SET ID: 875d5256-ccd7-4289-b533-a136da7a3578
• Manufacturer:
  • Denison Pharmaceuticals, LLC.
• UNII:
  • 31PZ2VAU81

NDC Crossover Matching brand name "DEBROX" or generic name "Carbamide Peroxide"

NDC	Brand Name	Generic Name
0295-1231	DEBROX	Carbamide Peroxide
50090-4201	DEBROX	Carbamide Peroxide
71205-136	DEBROX	DEBROX
63029-322	DEBROX	DEBROX
63029-321	DEBROX	DEBROX
53145-311	Auralyt	Carbamide Peroxide
13709-230	ClearCanal Ear Wax Softerner Drops	Carbamide Peroxide
53943-838	Discount Drug Mart Earwax Removal Drops	CARBAMIDE PEROXIDE
53943-835	DISCOUNT drug mart FOOD FAIR earwax removal kit	CARBAMIDE PEROXIDE
47649-9001	Dr. Whitiss (8.3%)	CARBAMIDE PEROXIDE
47649-0101	Dr.Whitiss 10%	CARBAMIDE PEROXIDE
47649-1101	Dr.Whitiss 15%	CARBAMIDE PEROXIDE
47649-1201	Dr.Whitiss 20%	CARBAMIDE PEROXIDE
47649-1301	Dr.Whitiss 35%	CARBAMIDE PEROXIDE
24385-955	Ear Drops	Carbamide Peroxide
49794-003	Ear Wax Removal Aid	Carbamide Peroxide
11673-793	Ear Wax Removal Aid Drops	Carbamide peroxide
21130-793	Ear Wax Removal Aid Drops	Carbamide peroxide
0536-3000	Ear Wax Treatment	Carbamide Peroxide
21695-334	Ear Wax Treatment	Carbamide Peroxide
41250-835	Earwax Removal Kit	CARBAMIDE PEROXIDE
41163-835	Equaline Earwax Removal Drops	CARBAMIDE PEROXIDE
55319-835	Family Wellness Earwax Removal Earwax and Bulb	CARBAMIDE PEROXIDE
0295-1226	Gly-Oxide	Carbamide Peroxide
24385-503	Good Neighbor Pharmacy Ear System	Carbamide Peroxide
46122-556	Good Neighbor Pharmacy Earwax Removal	CARBAMIDE PEROXIDE
46122-557	Good Neighbor Pharmacy Earwax Removal Drops	CARBAMIDE PEROXIDE
41250-282	Meijer Earwax Removal Drops	CARBAMIDE PEROXIDE
0295-7362	Murine Ear	Carbamide peroxide
50090-3895	Murine Ear	Carbamide peroxide
13709-314	NeilMed Clear Canal Earwax Removal kit	Carbamide peroxide
15579-838	Otix Ear wax Removal Drops	CARBAMIDE PEROXIDE
15579-839	Otix Ear wax Removal System Ear wax and Bulb	CARBAMIDE PEROXIDE
55910-835	Rexall Earwax Removal	CARBAMIDE PEROXIDE
36800-835	TopCare Earwax Removal Kit	CARBAMIDE PEROXIDE