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 9 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rolaids Ultra Strength MintCALCIUM CARBONATE AND MAGNESIUM HYDROXIDEChattem, Inc.8806c912-ab83-4f45-ac78-e826bb3143d42026-01-14WarningsExact identifier
application number: M001
Rolaids Advanced Antacid Anti-gas Wild BerryCALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONEChattem, Inc.07649a83-0123-4bb5-b130-3067c7d052c52026-01-14WarningsExact identifier
application number: M001
CVS Health Extra Strength Sugar Free AntacidANTACIDCVS Pharmacy,Inc.f722e7ce-6cca-4850-a230-7510c7ca77542026-01-12WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEMedical Group Care LLC47e1a46c-5665-ac4c-e063-6294a90a9b812026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEMedical Group Care LLC47e19b30-3784-ad98-e063-6294a90aa5662026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Tropical FruitCALCIUM CARBONATEMedical Group Care LLC47e1bc32-baf5-ad9a-e063-6294a90ad5b42026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEMedical Group Care LLC47e1c7c7-4f3b-c04b-e063-6394a90a775f2026-01-08WarningsExact identifier
application number: M001
Sanar Baking Soda 8oz 100% pureSODIUM BICARBONATEEvi Labs47e7f801-3176-288c-e063-6394a90abef42026-01-08WarningsExact identifier
application number: M001
Xpect AntacidCALCIUM CARBONATECintas Corporation3ef4eac7-cc9d-4ee2-b93a-59b85dbc6e7c2026-01-08WarningsExact identifier
application number: M001
DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 FlozSODIUM BICARBONATEEvi Labs47330d09-7db1-254d-e063-6294a90ae7de2026-01-07WarningsExact identifier
application number: M001
DE LA CRUZ SODIUM BICARBONATE ANTACIDSODIUM BICARBONATEDLC Laboratories, Inc.fc469943-9749-45ee-93f7-90fdbcdc72152026-01-07WarningsExact identifier
application number: M001
De La Cruz DesempachoSODIUM BICARBONATEDLC LABORATORIES, INC.741e105a-3ed2-4fc7-ab06-273e515a2d162026-01-07WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472eafe8-aa7a-f435-e063-6294a90acf6b2025-12-30WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472f5bfc-c676-56da-e063-6294a90a74af2025-12-30WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472ffa66-938f-14e7-e063-6394a90ad0ca2025-12-30WarningsExact identifier
application number: M001
QC Ultra Strength Antacid Soft Chews, CherryQC ANTACID SOFT CHEWS, CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a97517-d3e7-d896-e063-6394a90acc952025-12-29WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATESelect Consumer Group3caa037e-3424-f9ce-e063-6294a90ac1e82025-12-27WarningsExact identifier
application number: M001
AntacidANTACIDXiamen Kang Zhongyuan Biotechnology Co., Ltd.17adb983-bb28-bf8b-e063-6394a90a7daa2025-12-26WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 grSODIUM BICARBONATEGRAXCELL PHARMACEUTICAL, LLC897dbb09-fb47-4e03-8cae-bf76d48a7a032025-12-25WarningsExact identifier
application number: M001
Gas ReliefSIMETHICONEH-E-B3f9f6560-312f-44b7-e063-6394a90a1c562025-12-24WarningsExact 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