Earache Remedy

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 Remedy
Generic name: EAR DROPS
Manufacturer: Vitality Works, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 49afb2c3-ee42-4be9-943a-36d73ded0004
SPL ID: 462f5699-1583-e885-e063-6394a90abbc6
Version: 10
Effective date: 2025-12-17
Source export date: 2026-11-06
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:04:02

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 Remedy	openfda.brand_name
generic name		EAR DROPS	openfda.generic_name
manufacturer name		Vitality Works, Inc.	openfda.manufacturer_name
ndc	package	64616-045-02	openfda.package_ndc
ndc	package	64616-045-01	openfda.package_ndc
ndc	product	64616-045	openfda.product_ndc
ndc11	package	64616004501	derived:openfda.package_ndc
ndc11	package	64616004502	derived:openfda.package_ndc
spl id		462f5699-1583-e885-e063-6394a90abbc6	id
spl set id		49afb2c3-ee42-4be9-943a-36d73ded0004	set_id
unii		C9TD27U172	openfda.unii
unii		W2469WNO6U	openfda.unii
unii		660YQ98I10	openfda.unii
unii		WQZ3G9PF0H	openfda.unii
unii		U0NQ8555JD	openfda.unii
unii		G0R4UBI2ZZ	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

Earache Remedy Keep this and all medicines out of reach of children. Before use with children under 3 years of age, or if you are pregnant or nursing seek the advice of your health care professional. Avoid contact with eyes. If symptoms persist for more than 4 days, or if there is discharge from the ear or perforation, discontinue use and contact your health care professional. In case of accedental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but this is not intended for internal use.

Reported adverse events (FAERS/openFDA)#

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