FDA.reportPublic FDA data

bismuth subsalicylate 35 MG/ML Oral Suspension [Kaopectate Reformulated Aug 2006]

RxCUI
1043048
RxNorm name
bismuth subsalicylate 35 MG/ML Oral Suspension [Kaopectate Reformulated Aug 2006]
Display name
KAOPECTATE REFORMULATED AUG 2006 (Oral Liquid)
Full name
bismuth subsalicylate 35 MG/ML Oral Suspension [Kaopectate Reformulated Aug 2006]
Term type
SBD
Status
Active
Strength
525 mg/15ml
Dose form
Susp
Route
Oral Liquid
Updated
2026-11-01 02:59:20

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122010
Active start
122010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
bismuth subsalicylate35 MG / 1 MLbismuth subsalicylatebismuth subsalicylate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Suspension316969

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
bismuth subsalicylate19478

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRKaopectate Reformulated Aug 2006 35 MG/ML Oral Suspension1NAMES
RxNorm Namebismuth subsalicylate 35 MG/ML Oral Suspension [Kaopectate Reformulated Aug 2006]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI10430481CODES
MMSL_CODEBD54781CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
55505-200-3655505-200Kaopectate Max Peppermint Flavor Anti Diarrheal bismuth subsalicylateKramer LaboratoriesM008
55505-229-6455505-229Kaopectate Bismuth SubsalicylateKRAMER LABORATORIESM008

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M00855505-200Kaopectate Max Peppermint Flavor Anti Diarrheal bismuth subsalicylateOTC MONOGRAPH DRUGKramer Laboratories

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 7 matching rows.

NDC11, Source, Active table
NDC11SourceActive
41167060505rxnav_ndcsyes
53076000045rxnav_ndcsyes
53076020036rxnav_ndcsyes
55505020036rxnav_ndcsyes
55505022964rxnav_ndcsyes
00009527301rxnav_historical
41167744902rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kaopectate Max Peppermint Flavor Anti DiarrhealBISMUTH SUBSALICYLATEKramer Laboratoriese7218045-a593-485b-a5ba-03f3b35cbec42025-12-19WarningsExact identifier
ndc (package): 55505-200-36
ndc (product): 55505-200
ndc11 (package): 55505020036
rxcui: 1043048
KaopectateBISMUTH SUBSALICYLATEKRAMER LABORATORIES18b79c8c-b2fd-449b-a154-7158c9b13cdd2025-10-15WarningsExact identifier
ndc (package): 55505-229-64
ndc (product): 55505-229
ndc11 (package): 55505022964
rxcui: 1043048

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
e7218045-a593-485b-a5ba-03f3b35cbec4Kaopectate Extra Strength 525 MG in 15 mL Oral Suspension, Reformulated Aug 2006 [PSN] · bismuth subsalicylate 35 MG/ML Oral Suspension [Kaopectate Reformulated Aug 2006] [SBD] · Kaopectate 525 MG per 15 ML Oral Suspension, Reformulated Aug 2006 [SY] · Kaopectate Reformulated Aug 2006 35 MG/ML Oral Suspension [SY]45Drug Facts20251219
18b79c8c-b2fd-449b-a154-7158c9b13cddKaopectate Extra Strength 525 MG in 15 mL Oral Suspension, Reformulated Aug 2006 [PSN] · bismuth subsalicylate 35 MG/ML Oral Suspension [Kaopectate Reformulated Aug 2006] [SBD] · Kaopectate 525 MG per 15 ML Oral Suspension, Reformulated Aug 2006 [SY] · Kaopectate Reformulated Aug 2006 35 MG/ML Oral Suspension [SY]41Kaopectate ® Extra Strength Peppermint 11oz Drug Facts20251015

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
e7218045-a593-485b-a5ba-03f3b35cbec4Drug FactsKramer Laboratories20251219
18b79c8c-b2fd-449b-a154-7158c9b13cddKaopectate ® Extra Strength Peppermint 11oz Drug FactsKRAMER LABORATORIES20251015
9e64b4bf-94f1-4d80-a635-c445b1494a0aKaopectate Peppermint Flavor Anti-DiarrhealChattem, Inc.20231023

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
FDASPLD001729BismuthCHEMhas_chemical_structurebismuth subsalicylate
FDASPLN0000180183BismuthEPChas_epcbismuth subsalicylate
MEDRTD001729BismuthCHEMhas_ingredientbismuth subsalicylate
MEDRTD009942Organometallic CompoundsCHEMhas_ingredientbismuth subsalicylate
MEDRTD012459SalicylatesCHEMhas_ingredientbismuth subsalicylate
MEDRTD001778Blood Coagulation DisordersDISEASEci_withbismuth subsalicylate
MEDRTD002644ChickenpoxDISEASEci_withbismuth subsalicylate
MEDRTD003967DiarrheaDISEASEmay_treatbismuth subsalicylate
MEDRTD004342Drug HypersensitivityDISEASEci_withbismuth subsalicylate
MEDRTD004405Dysentery, BacillaryDISEASEmay_treatbismuth subsalicylate
MEDRTD004415DyspepsiaDISEASEmay_treatbismuth subsalicylate
MEDRTD004927Escherichia coli InfectionsDISEASEmay_treatbismuth subsalicylate
MEDRTD006471Gastrointestinal HemorrhageDISEASEci_withbismuth subsalicylate
MEDRTD016481Helicobacter InfectionsDISEASEmay_treatbismuth subsalicylate
MEDRTD009325NauseaDISEASEmay_treatbismuth subsalicylate
MEDRTD011263Pregnancy Trimester, ThirdDISEASEci_withbismuth subsalicylate
MEDRTD013272Stomach DiseasesDISEASEmay_treatbismuth subsalicylate
MEDRTD014777Virus DiseasesDISEASEmay_treatbismuth subsalicylate
MEDRTN0000000226Acid-Base ActivityMOAhas_moabismuth subsalicylate
MEDRTN0000000160Cyclooxygenase InhibitorsMOAhas_moabismuth subsalicylate
MEDRTN0000009724Inhibition Gastric Acid SecretionPEhas_pebismuth subsalicylate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH35 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable SynonymKaopectate Extra Strength 525 MG in 15 mL Oral Suspension, Reformulated Aug 2006
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon