FDA.reportPublic FDA data

Stomach

Product NDC
66715-5555
11-digit product format
667155555
Labeler code
66715
Product ID
66715-5555_17cb55a2-da1f-8ada-e063-6394a90a63e1
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Lil' Drug Store Products, Inc
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-01
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
Brand name suffix
Circle K
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
05e14009-b35d-4711-b6f0-89b6d060b387Available 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-5555-4StomachCircle K237 mL in 1 BOTTLE, PLASTICLIQUID2377

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bismuth SubsalicylateACTIVE INGREDIENT62TEY51RR1STOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Bismuth CationACTIVE MOIETYZS9CD1I8YESTOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Benzoic acidINACTIVE INGREDIENT8SKN0B0MIMSTOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
D&C red NO. 22INACTIVE INGREDIENT1678RKX8RTSTOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
D&C red NO. 28INACTIVE INGREDIENT767IP0Y5NHSTOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCSTOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYSTOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
salicylic acidINACTIVE INGREDIENTO414PZ4LPZSTOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
sodium salicylateINACTIVE INGREDIENTWIQ1H85SYPSTOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
sorbic acidINACTIVE INGREDIENTX045WJ989BSTOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
WaterINACTIVE INGREDIENT059QF0KO0RSTOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-5555STOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID STOMACH CIRCLE K (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]7Current NDC, 1 package rows20240507_05e14009-b35d-4711-b6f0-89b6d060b387.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 32 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value Milk of MagnesiaMAGNESIUM HYDROXIDEPharmacy Value Alliance, LLCc3cdaa2b-db34-872d-e053-2995a90a38262023-12-20WarningsExact identifier
application number: M001
Calcium CarbonateCALCIUM CARBONATEHumco Holding Group, Inc.8b207b49-d3fd-4108-b611-dca27c9dc78a2023-12-15WarningsExact identifier
application number: M001
Humco Dewees CarminativeMAGNESIUM CARBONATEHumco Holding Group, inc.163bceeb-ca74-413e-88b9-5c7bc9bbeb0d2023-12-15WarningsExact identifier
application number: M001
Humco Milk of MagnesiaMAGNESIUM HYDROXIDEHumco Holding Group, Inc.b6c90fb4-2673-7e29-e053-2995a90ae9e12023-12-15WarningsExact identifier
application number: M001
Medis Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc5da32469-58fc-14b1-e053-2a91aa0a74c42023-12-15WarningsExact identifier
application number: M001
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.aa694e0d-7891-4870-8106-dd57f1e29fb42023-12-11WarningsExact identifier
application number: M001
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.ed1b03f0-fabc-4c1c-8e6d-9f15c380300c2023-12-11WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATERugby Laboratoriese73b5871-4a87-4473-ab00-5e5395be017d2023-12-06WarningsExact identifier
application number: M001
Inon AceMAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDESato Pharmaceutical Co., Ltd.a6e4475c-dfac-493c-b98a-21473e3b59d52023-12-06WarningsExact identifier
application number: M001
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
application number: M001
Aluminum hydroxide and Magnesium carbonateALUMINUM HYDROXIDE, MAGNESIUM CARBONATESimpex Pharma Pvt. Ltde799a555-bfd0-4298-a5dc-aeb671815d402023-11-29WarningsExact identifier
application number: M001
Inon AceMAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONESato Pharmaceutical Co., Ltd.0af4355f-e160-409d-8471-2de98dbc6f7c2023-11-10WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd00ead8-026c-6610-e053-6394a90a0f112023-11-08WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd67566a-1078-019d-e053-6394a90a415c2023-11-08WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONESTRATEGIC SOURCING SERVICES LLCfd7a0a90-6570-c722-e053-6394a90a03f42023-11-08WarningsExact identifier
application number: M001
GERI-LANTA SUPREME CHERRYCALCIUM CARBONATE, MAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp7fbc654b-a0d4-408c-bb5a-eb50b7b543822023-11-08WarningsExact identifier
application number: M001
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d6916ec-e87f-6421-e053-2991aa0a33642023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d68366d-fee9-2acf-e053-2991aa0a7e4b2023-11-07WarningsExact identifier
application number: M001
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d7ed0c5-911c-299a-e053-2a91aa0aae562023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5e1eed65-0d4c-2d02-e053-2991aa0a95c12023-11-07WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN05e14009-b35d-4711-b6f0-89b6d060b3877
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD05e14009-b35d-4711-b6f0-89b6d060b3877
308762bismuth subsalicylate 1.75 % Oral SuspensionSY05e14009-b35d-4711-b6f0-89b6d060b3877
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY05e14009-b35d-4711-b6f0-89b6d060b3877
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY05e14009-b35d-4711-b6f0-89b6d060b3877
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY05e14009-b35d-4711-b6f0-89b6d060b3877

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66715-5555-466715555504237 mL in 1 BOTTLE, PLASTIC (66715-5555-4) 237 ml2021-03-05NoNoCurrent