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 34 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e82a4f4-c7da-09cb-e053-2a91aa0abf5b2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEWAL-MART STORES, INC.7cc2ad32-fdff-0772-e053-2a91aa0aad9e2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWAL-MART STORES, INC.7cc2771e-abd7-4120-e053-2a91aa0a8af02023-11-01WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEProficient Rx LPb7711b50-c14a-44d6-b647-1f31284f87ea2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e811783-cbf6-d0e3-e053-2991aa0ae69f2023-10-31WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS5f880b43-2977-7a2d-e053-2991aa0a024d2023-10-31WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYd5661964-9d2c-7a3d-e053-2995a90a86ef2023-10-31WarningsExact identifier
application number: M001
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS PHARMACY,INC.53fc327e-e345-26f2-e054-00144ff8d46c2023-10-31WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGAS CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e94cb90-b616-dcfe-e053-2a91aa0ada722023-10-31WarningsExact identifier
application number: M001
CALCIUM CARBONATE CHEWABLE ANTACIDCALCIUM CARBONATEGeri-Care Pharmaceutical Corp27d9b505-08bd-4261-a59d-6ddc4031be322023-10-25WarningsExact identifier
application number: M001
CALCIUM CARBONATECALCIUM CARBONATEBlessings International99d7e467-a3db-b4f0-e053-2a95a90a900f2023-10-25WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEAPNAR PHARMA LPe206c240-55c2-2d00-e053-2a95a90a17792023-10-21Boxed warning, WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEAPNAR PHARMA LPe4ef2224-07e4-e913-e053-2995a90a28ed2023-10-21WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEEndo USAd5c123f8-1396-4d8c-96d3-e5ade96a6ef82020-11-10WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEEndo USAd3c5b01b-f0d6-4503-ab18-b1a72386e2c62020-06-03WarningsExact identifier
application number: M001
Magnesium Oxide 400mgMAGNESIUM OXIDE 400MGAllegiant Health2ea68874-8c20-4284-bd0a-f07768057b832019-01-28WarningsExact identifier
application number: M001
Calcium AntacidCALCIUM CARBONATEAllegiant Health51dd53e8-22ff-4967-9124-f15c3986e4dd2017-11-17WarningsExact identifier
application number: M001
Calcium AntacidCALCIUM CARBONATEAllegiant Health551d6135-2650-4c27-a20d-d56a9aba7b712017-11-08WarningsExact 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