FDA label f650e162-6d2c-46b6-800d-1454d2ce0eae

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)

SPL set ID: 2dae0ac4-5f2d-41f2-aa89-9fd3b422d78b
SPL ID: f650e162-6d2c-46b6-800d-1454d2ce0eae
Version: 2
Effective date: 2022-03-08
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:33:29

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 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		f650e162-6d2c-46b6-800d-1454d2ce0eae	id
spl set id		2dae0ac4-5f2d-41f2-aa89-9fd3b422d78b	set_id

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: Do not use unless you have been diagnosed by a physician with oral herpes or genital herpes. CAUTION: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Not recommended for children under 12. If you are pregnant or breast-feeding, ask your doctor before use. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK SEAL AROUND NECK AND CAP IS BROKEN OR MISSING.

Reported adverse events (FAERS/openFDA)#

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