FDA label e673de3f-7483-4b80-955a-7ffda9a12935

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: 3ff89bf8-5293-4459-a47a-02d876214137
SPL ID: e673de3f-7483-4b80-955a-7ffda9a12935
Version: 3
Effective date: 2018-05-03
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:58:12

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		e673de3f-7483-4b80-955a-7ffda9a12935	id
spl set id		3ff89bf8-5293-4459-a47a-02d876214137	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.