Ear Drops Major

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 Major
Generic name: CARBAMIDE PEROXIDE 6.5%
Manufacturer: Major Pharmaceuticals
Product type: HUMAN OTC DRUG
SPL set ID: ad8bce05-6be4-4f6c-9341-bce7c3aa05cf
SPL ID: 3afc65d5-4dbc-d1c5-e063-6294a90a41d6
Version: 7
Effective date: 2025-07-28
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 05:54:16

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		Ear Drops Major	openfda.brand_name
generic name		CARBAMIDE PEROXIDE 6.5%	openfda.generic_name
manufacturer name		Major Pharmaceuticals	openfda.manufacturer_name
ndc	package	0904-6627-35	openfda.package_ndc
ndc	product	0904-6627	openfda.product_ndc
ndc11	package	00904662735	derived:openfda.package_ndc
rxcui		702050	openfda.rxcui
spl id		3afc65d5-4dbc-d1c5-e063-6294a90a41d6	id
spl set id		ad8bce05-6be4-4f6c-9341-bce7c3aa05cf	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

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