Topcare Swimmers Ear 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: Topcare Swimmers Ear Drops
Generic name: ISOPROPYL ALCOHOL
Manufacturer: Topco Associates LLC
Product type: HUMAN OTC DRUG
SPL set ID: 0fddeb43-fee0-d43c-e063-6394a90a738a
SPL ID: 0fddeb43-fee1-d43c-e063-6394a90a738a
Version: 1
Effective date: 2024-01-26
Source export date: 2026-10-30
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/0b630a6825fc0c8abba22d7c8fd4d069bde78bef928766047ddbb369119f337f/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:56:42

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M014	openfda.application_number
brand name		Topcare Swimmers Ear Drops	openfda.brand_name
generic name		ISOPROPYL ALCOHOL	openfda.generic_name
manufacturer name		Topco Associates LLC	openfda.manufacturer_name
ndc	package	76162-107-01	openfda.package_ndc
ndc	product	76162-107	openfda.product_ndc
ndc11	package	76162010701	derived:openfda.package_ndc
rxcui		631799	openfda.rxcui
spl id		0fddeb43-fee1-d43c-e063-6394a90a738a	id
spl set id		0fddeb43-fee0-d43c-e063-6394a90a738a	set_id
unii		ND2M416302	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

Flammable : Keep away from fire or flame. Do not use in eyes. Ask a doctor before use if you have ear drainage or discharge pain, irritation or rash in ear had ear surgery dizziness Stop us and ask a doctor if irritation (too much burning) or pain occurs

Reported adverse events (FAERS/openFDA)#

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