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: Proficient Rx LP
Product type: HUMAN OTC DRUG
SPL set ID: 76f7525d-2005-4da8-a795-50ede6236c68
SPL ID: 96ea8a54-d84e-4ac6-9ce1-2624f20a4992
Version: 6
Effective date: 2022-07-01
Source export date: 2026-10-12
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:43:38

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 · 14 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		Proficient Rx LP	openfda.manufacturer_name
ndc	package	63187-111-15	openfda.package_ndc
ndc	package	63187-111-30	openfda.package_ndc
ndc	product	63187-111	openfda.product_ndc
ndc11	package	63187011130	derived:openfda.package_ndc
ndc11	package	63187011115	derived:openfda.package_ndc
rxcui		992528	openfda.rxcui
spl id		96ea8a54-d84e-4ac6-9ce1-2624f20a4992	id
spl set id		76f7525d-2005-4da8-a795-50ede6236c68	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.