Bismuth subsalicylate

Product NDC
68071-4523
11-digit product format
680714523
Labeler code
68071
Product ID
68071-4523_d775143a-5ca3-9d10-e053-2995a90a7eb7
Type
HUMAN OTC DRUG
Nonproprietary name
Sunmark Stomach relief
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-03-01
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 productproduct68071-4523DDiscontinued by firm2026-10-05
excluded packagepackage68071-452368071-4523-3DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-4523-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-4523-3f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4523-32022-02-07C16284748780-1d6a99b39-cf73-a426-e053-dadaa90af4c2Sunmark Stomach relief tablets Regular Strength
68071-4523-32022-01-28C16284748780-1d6a99b39-cf73-a426-e053-dadaa90af4c2Sunmark Stomach relief tablets Regular Strength

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4523-36807145230330 TABLET, CHEWABLE in 1 BOX (68071-4523-3) 2018-08-100000-00-00NoNoCurrent