FDA.reportPublic FDA data

Topco Stomach Relief

Product NDC
36800-104
11-digit product format
368000104
Labeler code
36800
Product ID
36800-104_b1cb24b0-ba9b-497e-882e-951f6c1128e7
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
Topco Associates, LLC
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-01
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
Topco Stomach Relief
Listing expiration
2026-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a5be682-f13b-41a4-bf8c-724bffab2e92Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-104-28Topco Stomach Relief40 in 1 BOTTLETABLET403
36800-104-28Topco Stomach Relief1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-104TOPCO STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET [TOPCO ASSOCIATES, LLC]3Current NDC, Legacy NDC, 2 package rows20241228_7a5be682-f13b-41a4-bf8c-724bffab2e92.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 5 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreen Stomach ReliefBISMUTH SUBSALICYLATEWALGREENS CO.53fdceb2-68ea-42b9-87eb-f202e96eb5242025-11-25WarningsExact identifier
application number: M008
WalgreenBISMUTH SUBSALICYLATEWALGREEN CO.73231515-840f-4086-86da-4b815d664c132025-11-25WarningsExact identifier
application number: M008
Percy MedicineBISMUTH SUBSALICYLATEMerrick Medicine Company, Inc08dd53b7-8345-4849-9155-60429cbe2c512025-11-11WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)d28ef2ae-2b0a-4f32-9bc1-6803806f3c812025-11-11WarningsExact identifier
application number: M008
TopCare Regular StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLC2619720a-d926-4b17-899c-54d49c78802c2025-11-10WarningsExact identifier
application number: M008
TopCare Stomach Relief Regular StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLCb93a0b38-eb5f-47c0-8112-75505e46f7c32025-11-10WarningsExact identifier
application number: M008
TopCare Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLCe745e693-9e45-43b0-b26c-99ca891b74b02025-11-10WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)6298b856-90ea-4054-bda3-70f92b14611d2025-11-10WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)61309786-96ee-4d9b-8dd3-8e4a91ebe88c2025-11-07WarningsExact identifier
application number: M008
up and up digestive reliefBISMUTH SUBSALICYLATETarget Corporation5731025d-ffaa-4b31-971f-e58b921e40ed2025-11-05WarningsExact identifier
application number: M008
ULTRA STRENGHT PINK BISMUTHBISMUTH SUBSALICYLATETARGET CORPORATION20063215-f657-487b-9530-6df0181b440a2025-11-05WarningsExact identifier
application number: M008
up and up 5-symptom digestive reliefBISMUTH SUBSALICYLATETarget Corporation7f6b2960-943d-464c-9ff9-4649a8ab4a4e2025-11-04WarningsExact identifier
application number: M008
up and up 5-symptom digestive reliefBISMUTH SUBSALICYLATETarget Corporation6462e224-5ee7-4556-90f2-994eaf89b71b2025-11-04WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATESAFEWAYba698d38-83f1-4257-9c43-e7a55dbb206e2025-10-29WarningsExact identifier
application number: M008
Digestive ReliefBISMUTH SUBSALICYLATESAFEWAY5538d56a-b258-4260-b51b-f5131bd768852025-10-29WarningsExact identifier
application number: M008
Chewable Stomach ReliefBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS INC,2a316e06-5c16-46b8-b9ac-71fe0f92c5152025-10-28WarningsExact identifier
application number: M008
PUBLIX Regular Strength Pink BismuthBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS, INCa9b2da55-5171-4702-9808-5b937182da022025-10-28WarningsExact identifier
application number: M008
PUBLIX Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS, INC4be86e84-fddf-4eb5-a519-64009d0e69fc2025-10-28WarningsExact identifier
application number: M008
Pepto-BismolBISMUTH SUBSALICYLATEASCLEMED USA INC.01b318d2-586d-4953-8f98-addc4e3cd4412025-10-15WarningsExact identifier
application number: M008
KaopectateBISMUTH SUBSALICYLATEKRAMER LABORATORIES18b79c8c-b2fd-449b-a154-7158c9b13cdd2025-10-15WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN7a5be682-f13b-41a4-bf8c-724bffab2e923
308760bismuth subsalicylate 262 MG Oral TabletSCD7a5be682-f13b-41a4-bf8c-724bffab2e923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-104-28368000104281 BOTTLE in 1 CARTON (36800-104-28) / 40 TABLET in 1 BOTTLE1 bottle2020-10-010000-00-00NoNoCurrent