Upset Stomach Relief-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: Upset Stomach Relief-Bismuth Subsalicylate 262 mg
Generic name: BISMUTH SUBSALICYLATE 262 MG
Manufacturer: Pioneer Life Sciences, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 07e2cc82-ab0e-46c5-863b-67658b612678
SPL ID: 3eab8dc9-d54c-4921-864f-a944cbb43a7c
Version: 1
Effective date: 2025-06-27
Source export date: 2026-10-12
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/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:10:09

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		Upset Stomach Relief-Bismuth Subsalicylate 262 mg	openfda.brand_name
generic name		BISMUTH SUBSALICYLATE 262 MG	openfda.generic_name
manufacturer name		Pioneer Life Sciences, LLC	openfda.manufacturer_name
ndc	package	72090-053-01	openfda.package_ndc
ndc	product	72090-053	openfda.product_ndc
ndc11	package	72090005301	derived:openfda.package_ndc
rxcui		2121072	openfda.rxcui
spl id		3eab8dc9-d54c-4921-864f-a944cbb43a7c	id
spl set id		07e2cc82-ab0e-46c5-863b-67658b612678	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.