Bismatrol

Product NDC
63187-650
Requested package NDC
63187-650-30
11-digit product format
631870650
Labeler code
63187
Product ID
63187-650_81b530d1-1156-4106-a003-0caadb83839f
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Proficient Rx LP
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2003-01-03
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63187-65063187-650-30DDiscontinued by firm2026-10-16

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-65063187-650-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-65063187-650-30DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-650BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [PROFICIENT RX LP]5Legacy NDC20240123_003dbf85-8eb3-4587-944b-62c274b81172.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-650-30631870650305 BLISTER PACK in 1 CARTON (63187-650-30) > 6 TABLET, CHEWABLE in 1 BLISTER PACK5 blister pack2018-12-010000-00-00NoNoCurrent