debrox

Generic: carbamide peroxide

Labeler: a-s medication solutions
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name debrox
Generic Name carbamide peroxide
Labeler a-s medication solutions
Dosage Form LIQUID
Routes
AURICULAR (OTIC)
Active Ingredients

carbamide peroxide 65 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4201
Product ID 50090-4201_b34a6756-91f6-448d-be3f-a40632075df0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M014
Listing Expiration 2026-12-31
Marketing Start 2012-08-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904201
Hyphenated Format 50090-4201

Supplemental Identifiers

RxCUI
702050 827654
UNII
31PZ2VAU81

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name debrox (source: ndc)
Generic Name carbamide peroxide (source: ndc)
Application Number M014 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 65 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (50090-4201-0) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

50090-4201-0 1 BOTTLE, DROPPER in 1 CARTON (50090-4201-0) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (1)

carbamide peroxide (65 mg/mL)

Linked Drug Pages (1)

DEBROX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "b34a6756-91f6-448d-be3f-a40632075df0", "openfda": {"unii": ["31PZ2VAU81"], "rxcui": ["702050", "827654"], "spl_set_id": ["8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (50090-4201-0)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "50090-4201-0", "marketing_start_date": "20190319"}], "brand_name": "DEBROX", "product_id": "50090-4201_b34a6756-91f6-448d-be3f-a40632075df0", "dosage_form": "LIQUID", "product_ndc": "50090-4201", "generic_name": "Carbamide Peroxide", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DEBROX", "active_ingredients": [{"name": "CARBAMIDE PEROXIDE", "strength": "65 mg/mL"}], "application_number": "M014", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120801", "listing_expiration_date": "20261231"}