Premier Value Ear Relief 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: Premier Value Ear Relief Ear Drops
Generic name: CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR
Manufacturer: Chain Drug Consortium, LLC
Product type: HUMAN OTC DRUG
SPL set ID: b0db3da2-c180-4ff5-a8ee-4ec220798f64
SPL ID: bbfef157-79e8-7305-e053-2995a90aa962
Version: 2
Effective date: 2021-02-23
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 05:50:59

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
brand name		Premier Value Ear Relief Ear Drops	openfda.brand_name
generic name		CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR	openfda.generic_name
manufacturer name		Chain Drug Consortium, LLC	openfda.manufacturer_name
ndc	package	68016-377-00	openfda.package_ndc
ndc	product	68016-377	openfda.product_ndc
ndc11	package	68016037700	derived:openfda.package_ndc
spl id		bbfef157-79e8-7305-e053-2995a90aa962	id
spl set id		b0db3da2-c180-4ff5-a8ee-4ec220798f64	set_id
unii		324Y4038G2	openfda.unii
unii		FGL3685T2X	openfda.unii
unii		70FD1KFU70	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 in the eyes. Initial exacerbation may occur. Ask a doctor before use if you have: ear drainage or discharge pain, irritation, or rash in the ear had ear surgery dizziness Stop use and ask a doctor if: irritation (too much burning) or pain occurs symptoms persist for more than 48 hours If pregnant or breast feeding, ask a health professional before use. Keep out of 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.