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: A-S Medication Solutions
Product type: HUMAN OTC DRUG
SPL set ID: ef8370dc-8ca4-411d-87e1-dc6af3191330
SPL ID: d0db1c47-4dfe-443e-a514-09f727fb0b9f
Version: 14
Effective date: 2023-12-09
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:23:42

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		A-S Medication Solutions	openfda.manufacturer_name
ndc	package	50090-1278-0	openfda.package_ndc
ndc	product	50090-1278	openfda.product_ndc
ndc11	package	50090127800	derived:openfda.package_ndc
rxcui		992528	openfda.rxcui
spl id		d0db1c47-4dfe-443e-a514-09f727fb0b9f	id
spl set id		ef8370dc-8ca4-411d-87e1-dc6af3191330	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 eyes for vaginal yeast infections When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or gets worse 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.