FDA.reportPublic FDA data

Stomach

Product NDC
66715-6855
11-digit product format
667156855
Labeler code
66715
Product ID
66715-6855_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
Lil Drug Store Products
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
66715-6855-4StomachLil Drug Store Products237 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
66715-6855STOMACH LIL DRUG STORE PRODUCTS (BISMUTH SUBSALICYLATE) LIQUID STOMACH CIRCLE K (BISMUTH SUBSALICYLATE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]7Current NDC, Legacy 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 7 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONESportpharm LLCa70f113d-d5a3-44f5-b223-cd1b0e159e1a2026-04-24WarningsExact identifier
application number: M001
Genexa Kids Tummy ReliefCALCIUM CARBONATEGenexa Inc.4f9db9dc-6b78-d123-e063-6294a90ae38d2026-04-16WarningsExact identifier
application number: M001
Rugby Extra Strength AntacidCALCIUM CARBONATERugby Laboratoriesc15a5dde-6789-4491-98fd-d248a5c7f0762026-04-15WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERugby Laboratoriesbd58baac-5790-455a-9c77-2366809925792026-04-15WarningsExact identifier
application number: M001
Rugby Extra Strength AntacidCALCIUM CARBONATERugby Laboratories78f11b4b-d203-45c9-9b29-2c135eb666192026-04-15WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 gr. (650 mg)SODIUM BICARBONATEGendose Pharmaceuticals, LLC0a0cc46d-372e-4175-932a-065e82d8d3532026-04-13WarningsExact identifier
application number: M001
Extra Strength Antacid Calcium Carbonate, 750mgCALCIUM CARBONATE CHEWABLE TABLETSCVS HEALTH CORP24cdab48-bcc7-e66f-e063-6394a90abbd72026-04-11WarningsExact identifier
application number: M001
TUMS SmoothiesCALCIUM CARBONATEHaleon US Holdings LLCc22944b8-8733-4689-be0c-f320467f79ea2026-04-01WarningsExact identifier
application number: M001
Soothe childrensCALCIUM CARBONATEWalgreen Company0235e083-5f3d-4bae-b14a-b12db623180c2026-03-31WarningsExact identifier
application number: M001
Dulcolax Soft Chews Mixed BerryMAGNESIUM HYDROXIDEChattem, Inc.fe71907c-b1eb-4433-9337-933a944f3e622026-03-31WarningsExact identifier
application number: M001
AMAZON ULTRA STRENGTH ANTACIDCALCIUM CARBONATEAMAZON.COM SERVICES LLC36cf072c-ab61-47de-8fbc-f1d1d981ec842026-03-27WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepackf98cac25-63f2-478e-b785-20cba1c565652026-03-27WarningsExact identifier
application number: M001
Ultra Strength Assorted Fruit AntacidCALCIUM CARBONATEHyvee Inc44eaa023-0f11-1256-e063-6394a90a41672026-03-26WarningsExact identifier
application number: M001
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.4465441f-c518-8c1d-e063-6294a90a74072026-03-25WarningsExact identifier
application number: M001
Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEHyvee Inc44ea74ce-2b9f-e578-e063-6394a90ab72d2026-03-25WarningsExact identifier
application number: M001
Antacid MeltsCALCIUM CARBONATE 250MGQuest Products, LLC4dcc5323-eafe-0dc8-e063-6294a90acb602026-03-24WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.44657e4a-6093-bcab-e063-6394a90a48372026-03-19WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchCALCIUM CARBONATE AND SIMETHICONEBayer HealthCare LLC.41d17406-3653-4889-81df-6270b7b5d3c72026-03-12WarningsExact 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 startMarketing endSampleExclude flagStatus
66715-6855-466715685504237 mL in 1 BOTTLE, PLASTIC (66715-6855-4) 237 ml2020-06-010000-00-00NoNoCurrent