Bismuth Subsalicylate Suspension Regular Strength

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 Suspension Regular Strength
Generic name: BISMUTH SUBSALICYLATE
Manufacturer: FSA Store Inc. (Caring Mill)
Product type: HUMAN OTC DRUG
SPL set ID: fbabc313-600a-4722-9948-1a3e21414059
SPL ID: 85cccecc-9d78-43fe-86cc-9eea9027d4ba
Version: 1
Effective date: 2025-09-18
Source export date: 2026-10-27
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/6f51a1483736359ffd78ed7be27289bc51f2a8463b934465bee40efbdef4dfd7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 21:07:44

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 Suspension Regular Strength	openfda.brand_name
generic name		BISMUTH SUBSALICYLATE	openfda.generic_name
manufacturer name		FSA Store Inc. (Caring Mill)	openfda.manufacturer_name
ndc	package	81522-557-28	openfda.package_ndc
ndc	product	81522-557	openfda.product_ndc
ndc11	package	81522055728	derived:openfda.package_ndc
rxcui		308762	openfda.rxcui
spl id		85cccecc-9d78-43fe-86cc-9eea9027d4ba	id
spl set id		fbabc313-600a-4722-9948-1a3e21414059	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. 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.