Debrox Swimmers Ear

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 Swimmers Ear
Generic name: ISOPROPYL ALCOHOL
Manufacturer: Medtech Products Inc.
Product type: HUMAN OTC DRUG
SPL set ID: b5d57c7b-8315-4260-967e-38fdd54e2a9c
SPL ID: 26ccea52-4ce6-4e95-b838-4824523e579c
Version: 3
Effective date: 2025-10-23
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 06:05:14

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M014	openfda.application_number
brand name		Debrox Swimmers Ear	openfda.brand_name
generic name		ISOPROPYL ALCOHOL	openfda.generic_name
manufacturer name		Medtech Products Inc.	openfda.manufacturer_name
ndc	package	63029-323-01	openfda.package_ndc
ndc	product	63029-323	openfda.product_ndc
ndc11	package	63029032301	derived:openfda.package_ndc
rxcui		631799	openfda.rxcui
spl id		26ccea52-4ce6-4e95-b838-4824523e579c	id
spl set id		b5d57c7b-8315-4260-967e-38fdd54e2a9c	set_id
unii		ND2M416302	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

W arnings Flammable: Keep away from fire or flame Do not use in the eyes Ask a doctor before use if you have ear drainage or discharge ear pain, irritation or rash in the ear dizziness recently had ear surgery Stop use and ask a doctor if irritation (too much burning) or pain occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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