Devrom

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: Devrom
Generic name: BISMUTH SUBGALLATE
Manufacturer: The Parthenon Co., Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 6a9408b1-9085-42e6-9104-c6986d5446a9
SPL ID: 61d82c84-289a-4d83-a8ed-6c026f9edec9
Version: 3
Effective date: 2024-11-12
Source export date: 2026-11-06
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/d05434af5edc4383b7c7894a8f2d94df21171d17714450933cecdfc35cedfa3d/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:46:36

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M026	openfda.application_number
brand name		Devrom	openfda.brand_name
generic name		BISMUTH SUBGALLATE	openfda.generic_name
manufacturer name		The Parthenon Co., Inc.	openfda.manufacturer_name
ndc	package	49309-001-01	openfda.package_ndc
ndc	product	49309-001	openfda.product_ndc
ndc11	package	49309000101	derived:openfda.package_ndc
rxcui		1942846	openfda.rxcui
rxcui		308757	openfda.rxcui
spl id		61d82c84-289a-4d83-a8ed-6c026f9edec9	id
spl set id		6a9408b1-9085-42e6-9104-c6986d5446a9	set_id
unii		YIW503MI7V	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. When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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