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: AptaPharma Inc.
Product type: HUMAN OTC DRUG
SPL set ID: f0976d6c-d574-49e8-b98a-23a660d83fa0
SPL ID: ede65c2c-4034-46e5-9088-9efa801d6ec1
Version: 1
Effective date: 2026-06-02
Source export date: 2026-10-12
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:30:06

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		AptaPharma Inc.	openfda.manufacturer_name
ndc	package	76281-557-28	openfda.package_ndc
ndc	product	76281-557	openfda.product_ndc
ndc11	package	76281055728	derived:openfda.package_ndc
rxcui		308762	openfda.rxcui
spl id		ede65c2c-4034-46e5-9088-9efa801d6ec1	id
spl set id		f0976d6c-d574-49e8-b98a-23a660d83fa0	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.