Bismuth Subsalicylate 262 mg

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: Bismuth Subsalicylate 262 mg
Generic name: BISMUTH SUBSALICYLATE
Manufacturer: Preferred Pharmaceuticals Inc.
Product type: HUMAN OTC DRUG
SPL set ID: f7627bf1-da97-4875-b614-5029663f7482
SPL ID: f7627bf1-da97-4875-b614-5029663f7482
Version: 1
Effective date: 2026-06-08
Source export date: 2026-11-06
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/2026-11-06/7dfa569f2d8f065241260fd9a4886d0ef0a3120fd6ee31d6d07c234e689e8c91/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 08:23:10

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M008	openfda.application_number
brand name		Bismuth Subsalicylate 262 mg	openfda.brand_name
generic name		BISMUTH SUBSALICYLATE	openfda.generic_name
manufacturer name		Preferred Pharmaceuticals Inc.	openfda.manufacturer_name
ndc	package	68788-4116-3	openfda.package_ndc
ndc	product	68788-4116	openfda.product_ndc
ndc11	package	68788411603	derived:openfda.package_ndc
rxcui		308761	openfda.rxcui
spl id		f7627bf1-da97-4875-b614-5029663f7482	id
spl set id		f7627bf1-da97-4875-b614-5029663f7482	set_id
unii		62TEY51RR1	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 Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Reported adverse events (FAERS/openFDA)#

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