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: A-S Medication Solutions
Product type: HUMAN OTC DRUG
SPL set ID: eb7df1cc-50db-479a-bc1c-dfd7004dd35b
SPL ID: bac0c4d3-f01c-4ade-a739-51480e272328
Version: 6
Effective date: 2024-01-08
Source export date: 2026-10-12
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:54:21

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		A-S Medication Solutions	openfda.manufacturer_name
ndc	package	50090-5273-0	openfda.package_ndc
ndc	product	50090-5273	openfda.product_ndc
ndc11	package	50090527300	derived:openfda.package_ndc
rxcui		702050	openfda.rxcui
spl id		bac0c4d3-f01c-4ade-a739-51480e272328	id
spl set id		eb7df1cc-50db-479a-bc1c-dfd7004dd35b	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.