FDA.reportPublic FDA data

Terbinafine Hydrochloride

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Terbinafine Hydrochloride
Generic name
TERBINAFINE HYDROCHLORIDE
Manufacturer
Scholl's Wellness Company LLC
Product type
HUMAN OTC DRUG
SPL set ID
31f59302-eaee-211b-e063-6294a90a08b0
SPL ID
4e91f275-e628-27c4-e063-6294a90ad0c4
Version
4
Effective date
2026-04-03
Source export date
2026-08-01
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/2026-08-01/d245bd7ce31d1d8ed63276109973402ece6c44860774da30f25b731cd7418983/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:34:05
Harmonized routes table
Harmonized routes
TOPICAL

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.