Home FDA labels 4d7a01db-50f9-482e-b8d7-fbb87386968f Gastrotone 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)
Brand name Gastrotone
Generic name GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA (PRATENSIS), BISMUTHUM SUBNITRICUM
Manufacturer Energique, Inc.
Product type HUMAN OTC DRUG
SPL set ID 3e93ca93-0c1e-4305-bf0f-efd44c30a9d3
SPL ID 4d7a01db-50f9-482e-b8d7-fbb87386968f
Version 3
Effective date 2024-10-24
Source export date 2026-10-12
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:40:08 Harmonized routes table Harmonized routes ORAL
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 · 16 matching rows.
Type, Scope, Identifier table Type Scope Identifier Source field brand name Gastrotone openfda.brand_name generic name GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA (PRATENSIS), BISMUTHUM SUBNITRICUM openfda.generic_name manufacturer name Energique, Inc. openfda.manufacturer_name ndc package 44911-0563-1 openfda.package_ndc ndc product 44911-0563 openfda.product_ndc ndc11 package 44911056301 derived:openfda.package_ndc spl id 4d7a01db-50f9-482e-b8d7-fbb87386968f id spl set id 3e93ca93-0c1e-4305-bf0f-efd44c30a9d3 set_id unii 27YLU75U4W openfda.unii unii H19J064BA5 openfda.unii unii S72O3284MS openfda.unii unii S7V92P67HO openfda.unii unii 8E272251DI openfda.unii unii T4423S18FM openfda.unii unii CT03BSA18U openfda.unii unii C88X29Y479 openfda.unii
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: If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.