Terbinafine Hydrochloride

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: Terbinafine Hydrochloride
Generic name: TERBINAFINE HYDROCHLORIDE
Manufacturer: Preferred Pharmaceuticals, Inc
Product type: HUMAN OTC DRUG
SPL set ID: 6016e546-6c02-4af0-888c-c0899865c5f0
SPL ID: 02fc7642-968f-4ddf-a86a-146ed1a40162
Version: 9
Effective date: 2025-09-30
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:15:52

Harmonized routes table
Harmonized routes
TOPICAL

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	077511	derived:openfda.application_number
application number		ANDA077511	openfda.application_number
brand name		Terbinafine Hydrochloride	openfda.brand_name
generic name		TERBINAFINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Preferred Pharmaceuticals, Inc	openfda.manufacturer_name
ndc	package	68788-9814-1	openfda.package_ndc
ndc	product	68788-9814	openfda.product_ndc
ndc11	package	68788981401	derived:openfda.package_ndc
rxcui		992528	openfda.rxcui
spl id		02fc7642-968f-4ddf-a86a-146ed1a40162	id
spl set id		6016e546-6c02-4af0-888c-c0899865c5f0	set_id
unii		012C11ZU6G	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 For external use only Do not use • on nails or scalp • in or near the mouth or the eyes • for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if • too much irritation occurs or gets worse. • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Reported adverse events (FAERS/openFDA)#

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