Pediatric 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: Pediatric Earache Remedy
Generic name: EAR DROPS
Manufacturer: Vitality Works, Inc
Product type: HUMAN OTC DRUG
SPL set ID: 5769ce2c-d2e1-4069-92cc-e38bee668daf
SPL ID: 462ed52e-9da2-6cc3-e063-6294a90ad318
Version: 9
Effective date: 2025-12-17
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:55:55

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		Pediatric Earache Remedy	openfda.brand_name
generic name		EAR DROPS	openfda.generic_name
manufacturer name		Vitality Works, Inc	openfda.manufacturer_name
ndc	package	64616-050-02	openfda.package_ndc
ndc	package	64616-050-01	openfda.package_ndc
ndc	product	64616-050	openfda.product_ndc
ndc11	package	64616005002	derived:openfda.package_ndc
ndc11	package	64616005001	derived:openfda.package_ndc
spl id		462ed52e-9da2-6cc3-e063-6294a90ad318	id
spl set id		5769ce2c-d2e1-4069-92cc-e38bee668daf	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

Pediatric 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 you 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 accidental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but they are not intended for internal use.

Reported adverse events (FAERS/openFDA)#

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