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 33 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONECARDINAL HEALTH7ee3618a-43c8-2ccc-e053-2a91aa0a81152023-11-07WarningsExact identifier
application number: M001
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECARDINAL HEALTH7ee2f64b-9719-6aa0-e053-2991aa0aeb482023-11-07WarningsExact identifier
application number: M001
ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHaf5ea189-2118-4ffd-e053-2995a90aecfd2023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHb1a3cef7-a05e-bb39-e053-2995a90abfb52023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa9654a96-9bfd-60ea-e053-2995a90ae38d2023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEH E Babfe6688-f852-ba8e-e053-2995a90a49a32023-11-07WarningsExact identifier
application number: M001
ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGOODSENSEa9654a96-9bf9-60ea-e053-2995a90ae38d2023-11-07WarningsExact identifier
application number: M001
ADVANCED ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa964da1d-e1e3-94a8-e053-2a95a90ac8042023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEKROGER COMPANYa1b132d5-00d0-55c1-e053-2a95a90a8d272023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e5fc3f-caf0-84c4-e053-2a95a90af6552023-11-07WarningsExact identifier
application number: M001
ANTACID PLUSALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEBETTER LIVING BRANDS LLCb8e233c7-eaa0-b1ec-e053-2a95a90a05492023-11-07WarningsExact identifier
application number: M001
Antacid PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEBETTER LIVING BRANDS, LLCb93191e8-28a7-6c8f-e053-2995a90ac3272023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ADVANCED ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEDOLGENCORP, LLCb6993a5a-6144-ba65-e053-2995a90aee9b2023-11-07WarningsExact identifier
application number: M001
HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONb4656a2f-a866-5f7a-e053-2995a90ac2c22023-11-06WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEChain Drug Marketing Association9f410b3a-5579-4fae-84b1-5cd35563451e2023-11-06WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEChain Drug Marketing Association60de23d0-6e75-3b97-e053-2a91aa0aea5e2023-11-06WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEMAJOR Pharmaceuticals Inc.536b143d-a1d7-4972-a90b-248e419370702023-11-02WarningsExact identifier
application number: M001
ALMACONE DOUBLE STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONERUGBY LABORATORIES25f22cff-2864-4853-a7f8-8edd9f8f3c292023-11-02WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e8215a4-0136-bfdd-e053-2991aa0a5ddf2023-11-01WarningsExact identifier
application number: M001
SUPREME ANTACIDCALCIUM CARBONATE, MAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e946ed2-819e-fb40-e053-2991aa0a6f772023-11-01WarningsExact 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