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: Medtech Products Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 43649ba3-75e0-4dcf-9172-23767dbaeda6
SPL ID: 69ef758d-a912-4696-8f5e-ac6cd1aa63dc
Version: 3
Effective date: 2025-01-27
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:04:33

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 · 14 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		Medtech Products Inc.	openfda.manufacturer_name
ndc	package	63029-321-01	openfda.package_ndc
ndc	package	63029-321-02	openfda.package_ndc
ndc	product	63029-321	openfda.product_ndc
ndc11	package	63029032102	derived:openfda.package_ndc
ndc11	package	63029032101	derived:openfda.package_ndc
rxcui		702050	openfda.rxcui
rxcui		827654	openfda.rxcui
spl id		69ef758d-a912-4696-8f5e-ac6cd1aa63dc	id
spl set id		43649ba3-75e0-4dcf-9172-23767dbaeda6	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.