FDA.reportPublic FDA data

Bismuth Subsalicylate

Product NDC
69842-346
11-digit product format
698420346
Labeler code
69842
Product ID
69842-346_4b96475f-d966-11d4-e063-6394a90a0361
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-06
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
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
Bismuth Subsalicylate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

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
308760Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6dd7c01c-5726-e6db-e053-2a91aa0a968dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-346-12Bismuth Subsalicylate1 in 1 CARTONTABLET, FILM COATED15
69842-346-12Bismuth Subsalicylate24 in 1 BOTTLETABLET, FILM COATED245
69842-346-28Bismuth Subsalicylate40 in 1 BOTTLETABLET, FILM COATED405
69842-346-28Bismuth Subsalicylate1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-346BISMUTH SUBSALICYLATE TABLET, FILM COATED [CVS PHARMACY, INC.]4Current NDC, Legacy NDC, 4 package rows20240124_6dd7c01c-5726-e6db-e053-2a91aa0a968d.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 31 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUMS CHEWY BITESCALCIUM CARBONATE TABLET, CHEWABLELil' Drug Store Products, Inc.f67bd767-e9f1-2377-e053-2a95a90a0a2d2024-03-29WarningsExact identifier
application number: M001
Childrens Robitussin Cough and Cold CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCfcd0a8e0-ac2a-039a-be3c-534195d6bcfd2024-03-17WarningsExact identifier
application number: M001
TUMSCALCIUM CARBONATEHaleon US Holdings LLC35f79dcf-1743-4d9f-aba5-5ead6b0563092024-03-15WarningsExact identifier
application number: M001
TUMS extra strength, smoothiesCALCIUM CARBONATEHaleon US Holdings LLC11078d7c-373b-4c7b-b33b-f1deba613fc12024-03-14WarningsExact identifier
application number: M001
Tums Chewy Bites Tropical Fruit SmoothieCALCIUM CARBONATEHaleon US Holdings LLC500f821e-dd27-4c7c-b629-a826b2e57c132024-03-11WarningsExact identifier
application number: M001
TUMSCALCIUM CARBONATEHaleon US Holdings LLC3988e3f8-b276-43a0-bdd3-01ddd422c9862024-03-03WarningsExact identifier
application number: M001
TUMS SmoothiesCALCIUM CARBONATEHaleon US Holdings LLC9e54f687-4072-42fd-a14b-af67fe8b6cc42024-03-03WarningsExact identifier
application number: M001
Tums Regular StrengthCALCIUM CARBONATEHaleon US Holdings LLCac80f627-3f51-425b-8c75-e07363048b002024-03-03WarningsExact identifier
application number: M001
Tums Chewy Bites Mixed FruitCALCIUM CARBONATEHaleon US Holdings LLCd341b832-edcf-4cb2-96e1-c303b030c59a2024-03-02WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC5090f60f-fa98-470b-bafd-bb64e6b28fcc2024-03-02WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC453ceee1-414b-4f4c-8408-eb540a79ca052024-03-02WarningsExact identifier
application number: M001
Tums Chewy Bites Berry ShakeCALCIUM CARBONATEHaleon US Holdings LLC9043983c-7ee4-4971-8885-36f814bb570f2024-03-02WarningsExact identifier
application number: M001
Tums Chewy DelightsCALCIUM CARBONATEHaleon US Holdings LLC189850d0-6f06-45bd-bd7e-9063ee580d0b2024-03-02WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfe04c244-d9b8-2800-e053-6294a90aeedc2024-02-06WarningsExact identifier
application number: M001
Mylanta ClassicCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a4cf29-39ed-87c3-e063-6394a90a49732024-02-05WarningsExact identifier
application number: M001
Mylanta Vanilla CaramelCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a66d74-74b4-3f8d-e063-6394a90a7f002024-02-05WarningsExact identifier
application number: M001
Mylanta Maximum Strength Vanilla Caramel FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.ace5cae4-3a78-41c3-987d-59ce22dca2ac2024-01-01WarningsExact identifier
application number: M001
Mylanta Coat and CoolCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEINFIRST HEALTHCARE INC.b6571f7f-e1ea-4034-a46c-4de1d01beec32024-01-01WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEPharma Nobis, LLCe42f674b-1a70-6a3c-e053-2995a90afa722023-12-22WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN6dd7c01c-5726-e6db-e053-2a91aa0a968d5
308760bismuth subsalicylate 262 MG Oral TabletSCD6dd7c01c-5726-e6db-e053-2a91aa0a968d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-346-12698420346121 BOTTLE in 1 CARTON (69842-346-12) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-07-060000-00-00NoNoCurrent
69842-346-28698420346281 BOTTLE in 1 CARTON (69842-346-28) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-07-060000-00-00NoNoCurrent