FDA label 78758019-7503-4111-a42d-391da71ac040

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: d9fc7633-cacc-4408-b9a8-b69047b30585
SPL ID: 78758019-7503-4111-a42d-391da71ac040
Version: 16
Effective date: 2023-07-27
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 01:30:44

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		78758019-7503-4111-a42d-391da71ac040	id
spl set id		d9fc7633-cacc-4408-b9a8-b69047b30585	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 For external use only: hands 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 REACTIONS DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

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