Stomach Relief - 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: Stomach Relief - Regular Strength
Generic name: BISMUTH SUBSALICYLATE
Manufacturer: AptaPharma Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 970b4118-2c2e-4806-8fe8-937ba06cf6e9
SPL ID: 0e43e21f-d421-4a57-9056-85b2f73aadd8
Version: 5
Effective date: 2023-12-30
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:03:24

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M008	openfda.application_number
brand name		Stomach Relief - Regular Strength	openfda.brand_name
generic name		BISMUTH SUBSALICYLATE	openfda.generic_name
manufacturer name		AptaPharma Inc.	openfda.manufacturer_name
ndc	package	76281-537-25	openfda.package_ndc
ndc	package	76281-537-28	openfda.package_ndc
ndc	product	76281-537	openfda.product_ndc
ndc11	package	76281053728	derived:openfda.package_ndc
ndc11	package	76281053725	derived:openfda.package_ndc
rxcui		308762	openfda.rxcui
spl id		0e43e21f-d421-4a57-9056-85b2f73aadd8	id
spl set id		970b4118-2c2e-4806-8fe8-937ba06cf6e9	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.