FDA.reportPublic FDA data

Kaopectate

Product NDC
55505-197
11-digit product format
555050197
Labeler code
55505
Product ID
55505-197_eb3ecda3-180e-4a04-9089-5cceabe22724
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Kramer Laboratories
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-01
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Kaopectate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62TEY51RR1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308760Internal RxNorm lookup
642349Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3877a88d-9546-48ce-ad6b-3c2a115e3eafAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-197-07Kaopectate28 in 1 BOTTLETABLET, COATED288
55505-197-07Kaopectate1 in 1 CARTONTABLET, COATED18
55505-197-70Kaopectate42 in 1 BOTTLETABLET, COATED428
55505-197-70Kaopectate1 in 1 CARTONTABLET, COATED18
55505-197-77Kaopectate84 in 1 BOTTLETABLET, COATED848
55505-197-77Kaopectate1 in 1 CARTONTABLET, COATED18
55505-197-78Kaopectate2 in 1 PACKAGETABLET, COATED28
55505-197-78Kaopectate1 in 1 CARTONTABLET, COATED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55505-197KAOPECTATE (BISMUTH SUBSALICYLATE) TABLET, COATED [KRAMER LABORATORIES]6Current NDC, Legacy NDC, 8 package rows20250419_3877a88d-9546-48ce-ad6b-3c2a115e3eaf.zip

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 3 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KaopectateBISMUTH SUBSALICYLATEKramer Laboratories3877a88d-9546-48ce-ad6b-3c2a115e3eaf2026-06-03WarningsExact identifier
application number: M008
ndc (product): 55505-197
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.f0976d6c-d574-49e8-b98a-23a660d83fa02026-06-02WarningsExact identifier
application number: M008
Stomach Relief Maximum StrengthBISMUTH SUBSALICYLATECVS Pharmacy9d8f2456-732d-40bf-a10c-98423560c0292026-05-13WarningsExact identifier
application number: M008
Green Guard Instydose Upset Stomach ReliefBISMUTH SUBSALICYLATEUnifirst First Aid Corporation5b1f31a9-8eec-4c3d-e063-6394a90a2efe2026-05-01WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)6f189c12-eb94-476e-a8f7-ea82f44c4aa52026-04-13WarningsExact identifier
application number: M008
Pepto BismolBISMUTH SUBSALICYLATENavajo Manufacturing Company Inc.033bccc6-6e81-487f-91fe-9d7cc465e1b22026-04-08WarningsExact identifier
application number: M008
SootheBISMUTH SUBSALICYLATEWalgreens450483c3-487f-4a8f-a439-5661241a8f0f2026-04-08WarningsExact identifier
application number: M008
GS Stomach ReliefBISMUTH SUBSALICYLATE 525 MGGood Sense (Geiss, Destin & Dunn, Inc.)edd15c7d-f66b-4b1a-8cda-9814a37904832026-03-31WarningsExact identifier
application number: M008
WALGREEN ULTRA STRENGTH PINK BISMUTHBISMUTH SUBSALICYLATEWALGREENS CO.d0f78754-2556-4aa8-949b-a6e3b4adf8c22026-03-25WarningsExact identifier
application number: M008
Dr. Simi Stomach ReliefBISMUTH SUBSALICYLATE 525 MGFarmacias De Similares TX LLC4dc9233e-68fb-e1e8-e063-6294a90aee332026-03-24WarningsExact identifier
application number: M008
Major Bismuth SubsalicylateBISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.69b9999f-c2e5-43a6-891f-0e24d3c343a42026-03-20WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEGrocery Outlet, Inc.4465dd17-c333-7b95-e063-6294a90a50532026-03-19WarningsExact identifier
application number: M008
AMAZON Regular StrengthBISMUTH SUBSALICYLATEAMAZON.COM SERVICES LLC6b41f36d-1810-45f7-a46c-67b9bff237382026-03-04WarningsExact identifier
application number: M008
AMAZON Digestive ReliefBISMUTH SUBSALICYLATEAMAZON.COM SERVICES LLCa9a676d8-06b9-43bf-9c06-08670c9ab2112026-03-04WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEWal-Mart Stores Inc2d7d563e-4c46-4788-b6a7-5b92e3d585332026-02-26WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEChain Drug Marketing Association, Inc.d63110ee-2d64-46dd-80bf-696c9b9d8d7c2026-02-26WarningsExact identifier
application number: M008
SIGNATURE CARE Ultra Strength StomachBISMUTH SUBSALICYLATESAFEWAY4b54fa21-d8ea-4497-aa32-17e47669c8e12026-02-20WarningsExact identifier
application number: M008
SIGNATURE CARE Regular StrengthBISMUTH SUBSALICYLATESAFEWAYb4643d99-90ce-4f00-a61a-a5371fe0f4242026-02-20WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEGrocery Outlet, Inc.44673b4f-1bf8-9db3-e063-6294a90a62f52026-02-14WarningsExact identifier
application number: M008
Treda UltraBISMUTH SUBSALICYLATELaboratorios Sanfer, S.A. de C.V.cfa7f37a-e18b-4929-b3a4-4126b0aa679a2026-02-12WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN3877a88d-9546-48ce-ad6b-3c2a115e3eaf8
642349Kaopectate 262 MG Oral Tablet, Reformulated Aug 2006PSN3877a88d-9546-48ce-ad6b-3c2a115e3eaf8
642349bismuth subsalicylate 262 MG Oral Tablet [Kaopectate Reformulated Aug 2006]SBD3877a88d-9546-48ce-ad6b-3c2a115e3eaf8
308760bismuth subsalicylate 262 MG Oral TabletSCD3877a88d-9546-48ce-ad6b-3c2a115e3eaf8
642349Kaopectate Reformulated Aug 2006 262 MG Oral TabletSY3877a88d-9546-48ce-ad6b-3c2a115e3eaf8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55505-197-07555050197071 BOTTLE in 1 CARTON (55505-197-07) / 28 TABLET, COATED in 1 BOTTLE1 bottle2020-10-010000-00-00NoNoCurrent
55505-197-70555050197701 BOTTLE in 1 CARTON (55505-197-70) / 42 TABLET, COATED in 1 BOTTLE1 bottle2021-02-010000-00-00NoNoCurrent
55505-197-77555050197771 BOTTLE in 1 CARTON (55505-197-77) / 84 TABLET, COATED in 1 BOTTLE1 bottle2025-11-15NoNoCurrent
55505-197-78555050197782 CARTON in 1 PACKAGE (55505-197-78) / 1 BOTTLE in 1 CARTON / 42 TABLET, COATED in 1 BOTTLE2 carton2025-04-23NoNoCurrent