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: EARACHE DROPS
Generic name: BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR
Manufacturer: Hyland's Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 9b18453e-e338-4b8e-9856-85aca8c46ee1
SPL ID: efa40953-abb8-885e-e053-2a95a90a6482
Version: 9
Effective date: 2022-12-12
Source export date: 2026-09-28
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:40:21

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 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		EARACHE DROPS	openfda.brand_name
generic name		BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR	openfda.generic_name
manufacturer name		Hyland's Inc.	openfda.manufacturer_name
ndc	package	54973-3172-2	openfda.package_ndc
ndc	package	54973-3172-1	openfda.package_ndc
ndc	product	54973-3172	openfda.product_ndc
ndc11	package	54973317201	derived:openfda.package_ndc
ndc11	package	54973317202	derived:openfda.package_ndc
spl id		efa40953-abb8-885e-e053-2a95a90a6482	id
spl set id		9b18453e-e338-4b8e-9856-85aca8c46ee1	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 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.