FDA.reportPublic FDA data

Quality Choice Stomach Relief 528

Product NDC
83324-021
11-digit product format
833240021
Labeler code
83324
Product ID
83324-021_ac8d100b-47c0-483e-bec7-289e54cb7337
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Chain Drug Marketing Association Inc.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-19
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/15mL
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
Quality Choice Stomach Relief 528
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/15mL

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
e065320d-09ee-4ab8-868a-ab3b4239e392Available 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
83324-021-08Quality Choice Stomach Relief 528236 mL in 1 BOTTLELIQUID2362

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-021-08ML - Milliliter83324-02183af1234-00ad-4006-a8fa-eab7f8a2896e12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-021QUALITY CHOICE STOMACH RELIEF 528 (BISMUTH SUBSALICYLATE) LIQUID [CHAIN DRUG MARKETING ASSOCIATION INC.]2Current NDC, 1 package rows20250105_e065320d-09ee-4ab8-868a-ab3b4239e392.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 2 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECare One (Retail Business Services, LLC.)1af2a7dd-45d7-41a0-af61-4a588f1c19852026-08-12WarningsExact identifier
application number: M008
WinCo FOODS Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODSacf82012-0e40-4d50-b1f1-f36dc3dfad842026-08-07WarningsExact identifier
application number: M008
WinCo FOODS Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODS19c14efc-bf5f-4ef5-a727-aaccfae093f02026-08-07WarningsExact identifier
application number: M008
WinCo FOODS Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODS LLC53ae695d-f812-462d-9487-8fb5db0aa27d2026-08-07WarningsExact identifier
application number: M008
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp212ccf1f-faaf-4f77-9722-28713fc427612026-08-05WarningsExact identifier
application number: M008
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp7c0ca713-643a-46bd-9d9a-21ac39c808c42026-08-05WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEShield Pharmaceuticals Corp8177318d-427b-4bfc-9d7f-51d1545f4eb82026-07-27WarningsExact identifier
application number: M008
Pepto Bismol ChewsBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companybb8d2ed8-54a2-2295-e053-2995a90a10ac2026-07-27WarningsExact identifier
application number: M008
Pepto Bismol ChewsBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companycfe9214d-25e9-7729-e053-2a95a90a0dfb2026-07-27WarningsExact identifier
application number: M008
Pepto BismolBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Company252b143f-eee8-f407-e063-6394a90a0a082026-07-27WarningsExact identifier
application number: M008
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4b20f189-e979-8198-e063-6294a90a71692026-07-16WarningsExact identifier
application number: M008
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4bd5aa23-37aa-b818-e063-6394a90ae06c2026-07-15WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)d20af4fb-d579-4d1e-86ae-342933f4de752026-07-15WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEWALMART INC. (see also Equate)369fe912-dd0e-4ff3-a597-5ee81332838a2026-07-15WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)642c14bd-be99-410b-9ba7-6e71c97052302026-07-15WarningsExact identifier
application number: M008
Good Neighbor Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEAMERISOURCE BERGEN71c30b10-db24-4a42-a4f4-db552e3d5fe62026-07-13WarningsExact identifier
application number: M008
Pepto Bismol CHEWABLESBISMUTH SUBSALICYLATESelect Consumer Group5611c6cb-5c0b-cf4e-e063-6394a90abff82026-07-07WarningsExact identifier
application number: M008
Green Guard Instydose Mucus ReliefGUAIFENESINUnifirst First Aid Corporation5b21bd13-d649-6570-e063-6394a90a51e92026-07-01WarningsExact identifier
application number: M008
Medique Guaicon InsydoseGUAIFENESINUnifirst First Aid Corporation5b230d04-3cf2-51e0-e063-6294a90a24982026-07-01WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATERugby Laboratories6166c04e-20c6-4678-b16d-5174744456982026-06-26WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSNe065320d-09ee-4ab8-868a-ab3b4239e3922
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCDe065320d-09ee-4ab8-868a-ab3b4239e3922
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSYe065320d-09ee-4ab8-868a-ab3b4239e3922
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSYe065320d-09ee-4ab8-868a-ab3b4239e3922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-021-0883324002108236 mL in 1 BOTTLE (83324-021-08) 236 ml2024-04-19NoNoCurrent