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 7 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revasol Peptic ReliefBISMUTH SUBSALICYLATERnv LLC30dc3a0a-3496-4bdf-e063-6394a90a62fd2025-03-21WarningsExact identifier
application number: M008
TopCare Bismuth Stomach ReliefBISMUTHTopCo308f4b2a-22ff-42b9-e063-6394a90acc752025-03-17WarningsExact identifier
application number: M008
Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEGuardian Drug Company25175eac-d15f-ce0d-e063-6394a90a06502025-03-10WarningsExact identifier
application number: M008
Pink Bismuth Regular StrengthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0c675e-72ce-4a22-e063-6394a90a3dff2025-02-27WarningsExact identifier
application number: M008
Pink BismuthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0ce5dd-9eb5-8568-e063-6394a90a1a292025-02-27WarningsExact identifier
application number: M008
Maximum Strength Pink BismuthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0d4508-e5a1-ba46-e063-6394a90aec2a2025-02-27WarningsExact identifier
application number: M008
Pink Bismuth OriginalBISMUTH SUBSALICYLATE 525 MGDiscount Drug Mart, Inc2e0cb7d7-4c4f-824a-e063-6394a90aa3a42025-02-27WarningsExact identifier
application number: M008
SIMETHICONESIMETHICONENuCare Pharmaceuticals,Inc.e07f6acc-1b75-d8eb-e053-2a95a90a7d9b2025-02-24WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEHarris Teeter, LLC2c51458b-869c-0283-e063-6394a90a4ff72025-02-12WarningsExact identifier
application number: M008
Max Strength Stomach ReliefBISMUTH SUBSALICYLATEHarris Teeter, LLC2c516139-0a6a-5ba6-e063-6394a90aa14a2025-02-12WarningsExact identifier
application number: M008
Bismuth SubsalicylateBISMUTH SUBSALICYLATELEADER/ Cardinal Health 110, Inc.d4af6694-910c-da17-e053-2995a90a84542025-02-11WarningsExact identifier
application number: M008
Regular Strength Stomach ReliefBISMUTH SUBSALICYLATEDOLGENCORP, INC.f2ec112f-213c-8a23-e053-2995a90a5f3f2025-02-10WarningsExact identifier
application number: M008
Maximum Strength Stomach ReliefBISMUTH SUBSALICYLATEGuardian Drug Companyaf899b52-7d8c-4485-9fb8-006dae53568a2025-02-10WarningsExact identifier
application number: M008
CVS Health Stomach Relief SOFTGELBISMUTH SUBSALICYLATECVS Pharmacy, Inc.273013b3-9f79-873d-e063-6394a90a66402025-01-24WarningsExact identifier
application number: M008
GNP Pink BismuthBISMUTH SUBSALICYLATEAmerisource Bergen9f5df648-298a-43e3-b250-8db6786fc93f2025-01-20WarningsExact identifier
application number: M008
Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATEReliable 1 Laboratories LLC2e40ffd8-1afa-43af-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M008
Equate Stomach ReliefBISMUTH SUBSALICYLATEWal-Mart Stores, Inc.1e8ae968-6d40-4ac7-9bce-01d086584b612025-01-09WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATECARDINAL HEALTH 110, LLC. DBA LEADERb38d815b-a249-46d1-a9d0-4e8efab3e56b2025-01-06WarningsExact identifier
application number: M008
Quality Choice Stomach Relief 528BISMUTH SUBSALICYLATEChain Drug Marketing Association Inc.e065320d-09ee-4ab8-868a-ab3b4239e3922025-01-03WarningsExact identifier
application number: M008
HEB Stomach ReliefBISMUTH SUBSALICYLATEH E Bfac642cf-f2f7-4857-b54f-82f1dcb400ab2024-12-26WarningsExact 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