Hylands Naturals Earache 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: Hylands Naturals Earache Drops
Generic name: BELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFUR
Manufacturer: Hyland's Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 017ed754-9fe8-2cb5-e063-6294a90ab2f6
SPL ID: 59d42624-de71-d5fa-e063-6394a90a7363
Version: 7
Effective date: 2026-08-24
Source export date: 2026-10-27
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/d7629e6f844435cfe6cb0cf8c5341c46775ea16c5af42c77a22a2ffe820a2cd2/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:52:12

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Hylands Naturals Earache Drops	openfda.brand_name
generic name		BELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFUR	openfda.generic_name
manufacturer name		Hyland's Inc.	openfda.manufacturer_name
ndc	package	54973-4124-1	openfda.package_ndc
ndc	product	54973-4124	openfda.product_ndc
ndc11	package	54973412401	derived:openfda.package_ndc
spl id		59d42624-de71-d5fa-e063-6394a90a7363	id
spl set id		017ed754-9fe8-2cb5-e063-6294a90ab2f6	set_id
unii		4M1169RWJD	openfda.unii
unii		H0G9379FGK	openfda.unii
unii		FGL3685T2X	openfda.unii
unii		70FD1KFU70	openfda.unii
unii		6GZW20TIOI	openfda.unii
unii		C88X29Y479	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 Keep away from eyes. Do not use if you have ear tubes, damaged ear drums or after ear surgery. Stop use and ask a doctor if: ■ symptoms persist for more than 48 hours or worsen. ■ any discharge from ear is present. ■ symptoms are accompanied by a fever. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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