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 25 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium Carbonate 1250 mgCALCIUM CARBONATECitraGen Pharmaceuticals, Inc.766b3f3f-8bd1-281c-e053-2991aa0af54b2025-01-30WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg)CALCIUM CARBONATECitraGen Pharmaceuticals, Inc.723b940d-4f4b-f2e6-e053-2991aa0a8bcc2025-01-30WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATECVS2bc4c71c-a9c5-17df-e063-6294a90ac88c2025-01-27WarningsExact identifier
application number: M001
Goodsense Ultra Strength AntacidCALCIUM CARBONATEGood Sense (Geiss, Destin & Dunn, Inc.)492deace-7ea1-4fe3-a4c7-b2c6f195d68c2025-01-20WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)Ulai Health LLC641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a2025-01-20WarningsExact identifier
application number: M001
GoodSense Extra Strength AntacidCALCIUM CARBONATEGoodSense2fcdeb06-17de-49d8-97bb-8d31e1c0c61f2025-01-20WarningsExact identifier
application number: M001
HEB Extra Stregth AntacidCALCIUM CARBONATEH E Bdcfe4c81-b6e0-4a9b-a521-f3ad0c0a8e482025-01-20WarningsExact identifier
application number: M001
Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEEverpharm LLC2bda74cb-e77d-46bb-e063-6394a90af5802025-01-16WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATECVS1bf90c0c-b639-1c06-e063-6394a90ab85b2025-01-16WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEWorld Perfumes Inca83544e4-ec09-1e95-e053-2995a90ab7b92025-01-15WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 grSODIUM BICARBONATEReliable 1 Laboratories LLC321a772c-c44c-3d4e-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M001
Calcium Carbonate 500 mgCALCIUM CARBONATEReliable 1 Laboratories LLC322f1b54-abe9-11a7-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a27a71-b7b2-12aa-e063-6294a90a312f2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a7720f-1e74-7578-e063-6394a90a5eae2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78060-7f0d-c4bd-e063-6294a90ae1522025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78a5c-e3b5-f362-e063-6394a90a08072025-01-15WarningsExact identifier
application number: M001
Rolaids Extra Strength MintCALCIUM CARBONATE AND MAGNESIUM HYDROXIDEChattem, Inc.604d79f3-cdfa-45e2-8c20-fa6e0ff09b2e2025-01-15WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidCALCIUM CARBONATEH E B19a3221f-e0c1-c47a-e063-6394a90a1f012025-01-14WarningsExact identifier
application number: M001
Childrens Stomach Relief AntacidCALCIUM CARBONATEH E B18fae1aa-1001-8035-e063-6394a90adc662025-01-14WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)Aphena Pharma Solutions - Tennessee, LLCac839363-94fd-4c60-b5b6-70e4488ce1dd2025-01-09WarningsExact 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