FDA.reportPublic FDA data

Stomach Relief

Product NDC
72476-736
11-digit product format
724760736
Labeler code
72476
Product ID
72476-736_74cc6383-aa3a-497e-a8c0-756113c8393e
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Care One (Retail Business Services, LLC.)
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-27
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
3c53adaa-275f-4164-b21e-285e4f03433eAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72476-736-082023-10-05C16284748780-1f386c649-a4f4-0266-e053-dadaa90a7c1aDrug Facts
72476-736-082023-01-30C16284748780-1f386c649-a4f4-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-736-08Stomach ReliefRegular Strength237 mL in 1 BOTTLE, PLASTICLIQUID2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-736STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [CARE ONE (RETAIL BUSINESS SERVICES, LLC.)]3Current NDC, Legacy NDC, 1 package rows20231006_3c53adaa-275f-4164-b21e-285e4f03433e.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 SuspensionPSN3c53adaa-275f-4164-b21e-285e4f03433e3
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD3c53adaa-275f-4164-b21e-285e4f03433e3
308762bismuth subsalicylate 1.75 % Oral SuspensionSY3c53adaa-275f-4164-b21e-285e4f03433e3
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY3c53adaa-275f-4164-b21e-285e4f03433e3
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY3c53adaa-275f-4164-b21e-285e4f03433e3
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY3c53adaa-275f-4164-b21e-285e4f03433e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72476-736-0872476073608237 mL in 1 BOTTLE, PLASTIC (72476-736-08) 237 ml2019-12-270000-00-00NoNoCurrent