Major Bismuth Subsalicylate

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: Major Bismuth Subsalicylate
Generic name: BISMUTH SUBSALICYLATE
Manufacturer: Preferred Pharmaceuticals Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 69b9999f-c2e5-43a6-891f-0e24d3c343a4
SPL ID: 6ad4aa56-96a5-413c-8abd-dec8ead6bb1a
Version: 4
Effective date: 2026-03-20
Source export date: 2026-09-28
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/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:27:20

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		Major Bismuth Subsalicylate	openfda.brand_name
generic name		BISMUTH SUBSALICYLATE	openfda.generic_name
manufacturer name		Preferred Pharmaceuticals Inc.	openfda.manufacturer_name
ndc	package	68788-8239-3	openfda.package_ndc
ndc	product	68788-8239	openfda.product_ndc
ndc11	package	68788823903	derived:openfda.package_ndc
rxcui		308761	openfda.rxcui
spl id		6ad4aa56-96a5-413c-8abd-dec8ead6bb1a	id
spl set id		69b9999f-c2e5-43a6-891f-0e24d3c343a4	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 behaviour 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. Allergy alert: Contains salicylate. Do not take if you are • allergic to salicylates (including aspirin) • taking other salicylate products

Reported adverse events (FAERS/openFDA)#

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