FDA.reportPublic FDA data

Stomach Relief

Product NDC
0536-1286
11-digit product format
005361286
Labeler code
0536
Product ID
0536-1286_0a9489df-bd8a-46f1-8183-6129c3cb66f8
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Rugby Laboratories
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-29
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
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
Stomach Relief
Brand name suffix
Regular Strength
Listing expiration
2027-12-31

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
6166c04e-20c6-4678-b16d-517474445698Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1286-36Stomach ReliefRegular Strength237 mL in 1 BOTTLE, PLASTICLIQUID2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1286STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]4Current NDC, Legacy NDC, 1 package rows20240829_6166c04e-20c6-4678-b16d-517474445698.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 8 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Stomach Relief cherryBISMUTH SUBSALICYLATETopco Associates, LLC154b4b8f-c4d6-414b-aac3-88475669e19d2024-12-26WarningsExact identifier
application number: M008
Topco Stomach ReliefBISMUTH SUBSALICYLATETopco Associates, LLC7a5be682-f13b-41a4-bf8c-724bffab2e922024-12-26WarningsExact identifier
application number: M008
HEB Stomach Relief CherryBISMUTH SUBSALICYLATEH E B0277d4d7-c254-4eea-8f2e-4936d015a80f2024-12-26WarningsExact identifier
application number: M008
Equaline Maximum Strength Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFI716a7b86-4f6e-493d-ba29-d81f6ecafbf22024-12-20WarningsExact identifier
application number: M008
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFId0607a4e-de81-4881-abc7-cf0cc72a9f922024-12-20WarningsExact identifier
application number: M008
Guardian Pink BismuthBISMUTH SUBSALICYLATEGuardian Drug Company7e83fdf2-4007-46a8-ae9d-eab5a8ff19152024-12-18WarningsExact identifier
application number: M008
Stomach Relief, Caseys 4goodBISMUTH SUBSALICYLATE SUSPENSIONLil' Drug Store Products, Inc.030bb176-08ae-6c68-e063-6394a90af5272024-12-16WarningsExact identifier
application number: M008
Foster and Thrive Stomach ReliefBISMUTH SUBSALICYLATEStrategic Sourcing Services LLCc73c6650-a7ac-4942-ae07-0bc660a0081f2024-12-12WarningsExact identifier
application number: M008
Foster and Thrive Regular Strength Stomach Relief 527BISMUTH SUBSALICYLATE 525 MGStrategic Sourcing Services LLCf204f9ab-645b-4656-93a1-90aa4c3699222024-12-12WarningsExact identifier
application number: M008
Foster and Thrive Stomach ReliefBISMUTH SUBSALICYLATEStrategic Sourcing Services LLCd18cd615-912a-4853-bb2e-225960cfe08b2024-12-12WarningsExact identifier
application number: M008
Topcare Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATETopco Associates, LLC908da10c-2ed1-4917-a98b-bab63d7990d42024-12-09WarningsExact identifier
application number: M008
Careone Stomach ReliefBISMUTH SUBSALICYLATERetail Business Services, LLC.214f64c9-29e4-353d-e063-6294a90a12b42024-11-26WarningsExact identifier
application number: M008
Anti-DiarrhealBISMUTH SUBSALICYLATELil' Drug Store Products, Inc.079901b3-393b-44f0-85c9-2d8911f2a42a2024-11-25WarningsExact identifier
application number: M008
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCe91ed8a1-0d45-402c-9c16-1ae72e695a372024-11-20WarningsExact identifier
application number: M008
Rapidol Stomach ReliefBISMUTH SUBSALICYLATEPharmadel LLCefba1aea-f468-4f63-e053-2995a90a545b2024-11-18WarningsExact identifier
application number: M008
RITE AID Regular Strength Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION48fe12a5-5ff0-4d35-8708-675de32a9ed02024-10-31WarningsExact identifier
application number: M008
Rite Aid Digestive ReliefBISMUTH SUBSALICYLATERITE AID CORPORATION816c4ec4-46d1-4e8e-ad91-a11946c487692024-10-30WarningsExact identifier
application number: M008
Rite Aid Stomach ReliefBISMUTH SUBSALICYLATERITE AID CORPORATIONe3d49cf7-922f-438f-bc62-487a9e4db0252024-10-30WarningsExact identifier
application number: M008
Rite Aid Stomach Relief Original FlavorBISMUTH SUBSALICYLATERITE AID CORPORATION5db6ad20-208e-4881-90fc-672762f70cca2024-10-30WarningsExact identifier
application number: M008
Rite Aid Regular Strngth Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION2c4acea0-dfa2-422d-a13f-17699de747e62024-10-30WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 1.75 % Oral SuspensionSY5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN6166c04e-20c6-4678-b16d-5174744456984
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD6166c04e-20c6-4678-b16d-5174744456984
308762bismuth subsalicylate 1.75 % Oral SuspensionSY6166c04e-20c6-4678-b16d-5174744456984
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY6166c04e-20c6-4678-b16d-5174744456984
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY6166c04e-20c6-4678-b16d-5174744456984
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY6166c04e-20c6-4678-b16d-5174744456984
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN401f8393-680c-e1a8-e063-6394a90a81ab1
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD401f8393-680c-e1a8-e063-6394a90a81ab1
308762bismuth subsalicylate 1.75 % Oral SuspensionSY401f8393-680c-e1a8-e063-6394a90a81ab1
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY401f8393-680c-e1a8-e063-6394a90a81ab1
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY401f8393-680c-e1a8-e063-6394a90a81ab1
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY401f8393-680c-e1a8-e063-6394a90a81ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1286-3600536128636237 mL in 1 BOTTLE, PLASTIC (0536-1286-36) 237 ml2020-03-290000-00-00NoNoCurrent