FDA.reportPublic FDA data

Stomach Relief

Product NDC
53942-558
11-digit product format
539420558
Labeler code
53942
Product ID
53942-558_9c832971-fd38-4183-acd5-d520aae9c8f6
Type
HUMAN OTC DRUG
Nonproprietary name
BISMUTH SUBSALICYLATE
Dosage form
SUSPENSION
Route
ORAL
Labeler
Demoulas Super Markets Inc
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-01
Substance
BISMUTH SUBSALICYLATE
Active strength
1050 mg/30mL
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
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE1050 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
308763Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2d55045-d4a4-4167-a20c-42932f35bab2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
53942-558-26Stomach ReliefMaximum Strength237 mL in 1 BOTTLESUSPENSION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-558STOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) SUSPENSION [DEMOULAS SUPER MARKETS INC]2Current NDC, Legacy NDC, 1 package rows20231230_b2d55045-d4a4-4167-a20c-42932f35bab2.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 10 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEP & L Development, LLC7a461b91-d11f-4cb9-be61-c7d91d2783022024-04-16WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEGobrands, Inc. (Goodnow)cd647eb7-6e03-415c-8249-89c126824d002024-04-03WarningsExact identifier
application number: M008
Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATECare One (Retail Business Services, LLC.)c443b640-18b0-4b7d-a13c-0accb915a8012024-03-05WarningsExact identifier
application number: M008
Stomach Relief - Regular StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.970b4118-2c2e-4806-8fe8-937ba06cf6e92023-12-30WarningsExact identifier
application number: M008
Stomach Relief, Maximum StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.cdd436f6-b769-49aa-9e6c-da512da9e6e32023-12-30WarningsExact identifier
application number: M008
Stomach Relief - Maximum StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.15cd9163-16d6-4332-9e26-77c05e0a26a72023-12-30WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEDemoulas Super Markets Inc9a95d198-f3ba-4bc3-a6f1-e065eb7e86f02023-12-29WarningsExact identifier
application number: M008
Stomach Relief Maximum StrengthBISMUTH SUBSALICYLATEDemoulas Super Markets Incb2d55045-d4a4-4167-a20c-42932f35bab22023-12-29WarningsExact identifier
application number: M008
ndc (product): 53942-558
STOMACH RELIEFBISMUTH SUBSALICYLATEConsumer Value Products, Inc.7526a3f2-ce7c-46c8-8ddf-1bcaf313876d2023-12-29WarningsExact identifier
application number: M008
Estomaquil PolvoBISMUTH SUBSALICYLATEProMex LLCcf94c99a-c489-45ec-bb13-3e6959e377de2023-11-29WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECare One (Retail Business Services, LLC.)3c53adaa-275f-4164-b21e-285e4f03433e2023-10-05WarningsExact identifier
application number: M008
Pepto-Bismol Chewable, TRAVEL BASIXBISMUTH SUBSALICYLATELil' Drug Store Products, Inc.dd2f2205-34d1-4960-bf37-bb8d534cd0e12023-10-03WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATECDMA- QCfe3cd0ce-933b-4ad3-a34f-c057a93561582021-06-16WarningsExact identifier
application number: M008
Topcare Stomach Relief Original StrengthBISMUTH SUBSALICYLATETopCo Associates, LLCe4b1929c-0967-44ea-8552-6549aa2a464e2018-12-14WarningsExact identifier
application number: M008
BismuthBISMUTH SUBSALICYLATEAllegiant Health015ca07a-f6b5-4741-a7b0-821cf6d4e4182018-11-07WarningsExact identifier
application number: M008
GastrobizBISMUTH SUBSALICYLATEAllegiant Healthaa516512-afd7-453f-9c73-5fa930cafac32018-09-11WarningsExact identifier
application number: M008
Pep TumBISMUTH SUBSALICYLATEFirst Aid Directbf966e9f-2f95-41cd-a6e5-b8eb521181d82017-12-22WarningsExact identifier
application number: M008
Bismuth ChewableBISMUTH SUBSALICYLATE 262 MGMarc Glassman, Inc.cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e2016-12-19WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSNb2d55045-d4a4-4167-a20c-42932f35bab22
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCDb2d55045-d4a4-4167-a20c-42932f35bab22
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSYb2d55045-d4a4-4167-a20c-42932f35bab22
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSYb2d55045-d4a4-4167-a20c-42932f35bab22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-558-2653942055826237 mL in 1 BOTTLE (53942-558-26) 237 ml2018-10-010000-00-00NoNoCurrent