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: Major Pharmaceuticals
Product type: HUMAN OTC DRUG
SPL set ID: 2a7c9cc1-206e-4018-b89d-7b634df43df6
SPL ID: 61f89479-7da0-4f57-b505-d7ad3c2c52cb
Version: 4
Effective date: 2025-07-11
Source export date: 2026-11-06
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:47:12

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		Major Pharmaceuticals	openfda.manufacturer_name
ndc	package	0904-7205-46	openfda.package_ndc
ndc	product	0904-7205	openfda.product_ndc
ndc11	package	00904720546	derived:openfda.package_ndc
rxcui		308761	openfda.rxcui
spl id		61f89479-7da0-4f57-b505-d7ad3c2c52cb	id
spl set id		2a7c9cc1-206e-4018-b89d-7b634df43df6	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.