Bismuth

Product NDC
48433-127
Requested package NDC
48433-127-10
11-digit product format
484330127
Labeler code
48433
Product ID
48433-127_2b96078c-0b5d-48a7-bbc3-19209568a118
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
Safecor Health, LLC
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-08-01
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage48433-12748433-127-10DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-127-01EA - Each48433-127d4f27b6f-7f22-410c-97e3-e904fd824f2212022-11-07
48433-127-10EA - Each48433-12787095a11-cf6a-4ad5-9673-138a33613bd612023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48433-127BISMUTH (BISMUTH SUBSALICYLATE) TABLET [SAFECOR HEALTH, LLC]3Legacy NDC20250110_ba4d807b-4c9b-48ba-a8ea-1f6358a825d7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48433-127-1048433012710100 BLISTER PACK in 1 BOX, UNIT-DOSE (48433-127-10) > 1 TABLET in 1 BLISTER PACK (48433-127-01) 100 blister pack2020-08-010000-00-00NoNoCurrent