DEBROX

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: DEBROX
Generic name: CARBAMIDE PEROXIDE
Manufacturer: A-S Medication Solutions
Product type: HUMAN OTC DRUG
SPL set ID: 8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1
SPL ID: b34a6756-91f6-448d-be3f-a40632075df0
Version: 13
Effective date: 2025-09-03
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:57:17

Harmonized routes table
Harmonized routes
AURICULAR (OTIC)

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M014	openfda.application_number
brand name		DEBROX	openfda.brand_name
generic name		CARBAMIDE PEROXIDE	openfda.generic_name
manufacturer name		A-S Medication Solutions	openfda.manufacturer_name
ndc	package	50090-4201-0	openfda.package_ndc
ndc	product	50090-4201	openfda.product_ndc
ndc11	package	50090420100	derived:openfda.package_ndc
rxcui		702050	openfda.rxcui
rxcui		827654	openfda.rxcui
spl id		b34a6756-91f6-448d-be3f-a40632075df0	id
spl set id		8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1	set_id
unii		31PZ2VAU81	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Ask a doctor before use if you have ear drainage or discharge • ear pain irritation or rash in the ear • dizziness an injury or perforation (hole) of the eardrum • recently had ear surgery When using this product avoid contact with the eyes Stop use and ask a doctor if you need to use for more than four days excessive earwax remains after use of this product

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.