EAR CARE 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: EAR CARE EARACHE DROPS
Generic name: ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFUR
Manufacturer: Rite Aid Corporation
Product type: HUMAN OTC DRUG
SPL set ID: 58f1f79f-f1dd-3094-e053-2991aa0ac591
SPL ID: 678c8e7e-1d5b-f12a-e053-2991aa0ab6cc
Version: 2
Effective date: 2018-03-16
Source export date: 2026-09-28
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/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:19:30

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		EAR CARE EARACHE DROPS	openfda.brand_name
generic name		ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFUR	openfda.generic_name
manufacturer name		Rite Aid Corporation	openfda.manufacturer_name
ndc	package	11822-3644-3	openfda.package_ndc
ndc	product	11822-3644	openfda.product_ndc
ndc11	package	11822364403	derived:openfda.package_ndc
spl id		678c8e7e-1d5b-f12a-e053-2991aa0ab6cc	id
spl set id		58f1f79f-f1dd-3094-e053-2991aa0ac591	set_id
unii		2E32821G6I	openfda.unii
unii		WQZ3G9PF0H	openfda.unii
unii		70FD1KFU70	openfda.unii
unii		G0R4UBI2ZZ	openfda.unii
unii		I76KB35JEV	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 USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN. Keep away from eyes. This product is intended to complement, not replace, standard medical treatment. Initial worsening of symptoms may occur. A physician should always be consulted to rule out serious causes. If pregnant or breast feeding, ask a health professional before use. Stop and ask a doctor it: Symptoms worsen or continue for more than 48 hours There is discharge from the ear. A fever of greater than 102° is present Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use: if you have ear drainage, irritation, discharge, or rash in the ear, consult a physician. With ear tubes, with damaged ear drums or after surgery. if drops become cloudy.

Reported adverse events (FAERS/openFDA)#

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