Pepto Bismol

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: Pepto Bismol
Generic name: BISMUTH SUBSALICYLATE
Manufacturer: The Procter & Gamble Manufacturing Company
Product type: HUMAN OTC DRUG
SPL set ID: 252b143f-eee8-f407-e063-6394a90a0a08
SPL ID: 579d234e-0ce5-e74d-e063-6394a90a9871
Version: 4
Effective date: 2026-07-27
Source export date: 2026-09-28
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/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:15:25

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M008	openfda.application_number
brand name		Pepto Bismol	openfda.brand_name
generic name		BISMUTH SUBSALICYLATE	openfda.generic_name
manufacturer name		The Procter & Gamble Manufacturing Company	openfda.manufacturer_name
ndc	package	84126-321-70	openfda.package_ndc
ndc	product	84126-321	openfda.product_ndc
ndc11	package	84126032170	derived:openfda.package_ndc
rxcui		211151	openfda.rxcui
rxcui		308761	openfda.rxcui
spl id		579d234e-0ce5-e74d-e063-6394a90a9871	id
spl set id		252b143f-eee8-f407-e063-6394a90a0a08	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.