FDA.reportPublic FDA data

Bismuth Subsalicylate

Product NDC
69842-799
11-digit product format
698420799
Labeler code
69842
Product ID
69842-799_edc59015-5f98-7ae3-e053-2a95a90ab3ee
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
CVS PHARMACY, INC.
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-07-09
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69842-799IInactivated by FDA2026-10-05
excluded packagepackage69842-79969842-799-12IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
69842-799-12Bismuth Subsalicylate12 in 1 BLISTER PACKCAPSULE, GELATIN COATED125
69842-799-12Bismuth Subsalicylate1 in 1 CARTONCAPSULE, GELATIN COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-799BISMUTH SUBSALICYLATE CAPSULE, GELATIN COATED [CVS PHARMACY, INC.]5Legacy NDC, 2 package rows20250101_dfb5ed78-99b5-4c8e-a36c-5e4c32fa021e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121072bismuth subsalicylate 262 MG Oral CapsulePSNdfb5ed78-99b5-4c8e-a36c-5e4c32fa021e5
2121072bismuth subsalicylate 262 MG Oral CapsuleSCDdfb5ed78-99b5-4c8e-a36c-5e4c32fa021e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-799-12698420799121 BLISTER PACK in 1 CARTON (69842-799-12) > 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK1 blister pack2020-07-090000-00-00NoNoCurrent