Kaopectate

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: Kaopectate
Generic name: BISMUTH SUBSALICYLATE
Manufacturer: KRAMER LABORATORIES
Product type: HUMAN OTC DRUG
SPL set ID: 18b79c8c-b2fd-449b-a154-7158c9b13cdd
SPL ID: c7ad4e0a-96fb-4cb5-998d-0b055155eae2
Version: 1
Effective date: 2025-10-15
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:27:04

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		Kaopectate	openfda.brand_name
generic name		BISMUTH SUBSALICYLATE	openfda.generic_name
manufacturer name		KRAMER LABORATORIES	openfda.manufacturer_name
ndc	package	55505-229-64	openfda.package_ndc
ndc	product	55505-229	openfda.product_ndc
ndc11	package	55505022964	derived:openfda.package_ndc
rxcui		1043048	openfda.rxcui
rxcui		308763	openfda.rxcui
spl id		c7ad4e0a-96fb-4cb5-998d-0b055155eae2	id
spl set id		18b79c8c-b2fd-449b-a154-7158c9b13cdd	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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.