ear drops

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: ear drops
Generic name: CARBAMIDE PEROXIDE 6.5%
Manufacturer: Bionpharma Inc.
Product type: HUMAN OTC DRUG
SPL set ID: e8bcf92c-ad32-49d5-e053-2995a90ae0c6
SPL ID: 507543ad-0cd9-75be-e063-6394a90aee95
Version: 4
Effective date: 2026-04-27
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:36:03

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M014	openfda.application_number
brand name		ear drops	openfda.brand_name
generic name		CARBAMIDE PEROXIDE 6.5%	openfda.generic_name
manufacturer name		Bionpharma Inc.	openfda.manufacturer_name
ndc	package	69452-377-95	openfda.package_ndc
ndc	package	69452-377-75	openfda.package_ndc
ndc	product	69452-377	openfda.product_ndc
ndc11	package	69452037775	derived:openfda.package_ndc
ndc11	package	69452037795	derived:openfda.package_ndc
rxcui		702050	openfda.rxcui
spl id		507543ad-0cd9-75be-e063-6394a90aee95	id
spl set id		e8bcf92c-ad32-49d5-e053-2995a90ae0c6	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 Do not use if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; consult a doctor If you have an injury or perforation (hole) of the ear or after ear surgery, unless directed by a doctor for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor. When using this product avoid contact with eyes Stop use and ask a doctor you need to use for more than four days excessive earwax remains after a four day treatment with this product Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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