FDA label 5fae791e-af67-3bdc-e053-2a91aa0ae801

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: 86963fc9-468c-4842-a76a-c5c1f5510c75
SPL ID: 5fae791e-af67-3bdc-e053-2a91aa0ae801
Version: 2
Effective date: 2017-12-06
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 06:22:32

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		5fae791e-af67-3bdc-e053-2a91aa0ae801	id
spl set id		86963fc9-468c-4842-a76a-c5c1f5510c75	set_id

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

• WARNINGS AND PRECAUTIONS Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

• ADVERSE EVENTS To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.

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