FDA.reportPublic FDA data

Premier Value Ear Relief Ear Drops

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical 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
2026-08-01
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/2026-08-01/29baabee7fa6726d72190670d84f1571113181a958a8119cbe97e8f0d1d955b2/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:16:46
Harmonized routes table
Harmonized routes
AURICULAR (OTIC)

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.