FDA.reportPublic FDA data

Stomach Relief

Product NDC
70000-0698
11-digit product format
700000698
Labeler code
70000
Product ID
70000-0698_411d9943-51fb-0d4d-e063-6394a90acf70
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
SUSPENSION
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-21
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
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
Stomach Relief
Brand name suffix
Regular Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

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
308762Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d6047a9-5557-487a-ae06-f904dac626c9Available 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
70000-0698-1Stomach ReliefRegular Strength236 mL in 1 BOTTLESUSPENSION2362

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0698-1ML - Milliliter70000-069843b385da-50df-47dd-9c03-ef8e834adb5512025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0698STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) SUSPENSION [CARDINAL HEALTH 110, LLC. DBA LEADER]1Current NDC, 1 package rows20241109_7d6047a9-5557-487a-ae06-f904dac626c9.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
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
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN7d6047a9-5557-487a-ae06-f904dac626c92
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD7d6047a9-5557-487a-ae06-f904dac626c92
308762bismuth subsalicylate 1.75 % Oral SuspensionSY7d6047a9-5557-487a-ae06-f904dac626c92
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY7d6047a9-5557-487a-ae06-f904dac626c92
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY7d6047a9-5557-487a-ae06-f904dac626c92
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY7d6047a9-5557-487a-ae06-f904dac626c92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0698-170000069801236 mL in 1 BOTTLE (70000-0698-1) 236 ml2024-10-21NoNoCurrent