FDA.reportPublic FDA data

Peptic Relief

Product NDC
15127-319
Requested package NDC
15127-319-01
11-digit product format
151270319
Labeler code
15127
Product ID
15127-319_d2c4273c-acac-4e9c-8819-6075dd0ce0ec
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
L&R Distributors, Inc.
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1998-07-16
Marketing end
2021-08-03
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage15127-31915127-319-01DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1PEPTIC RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L&R DISTRIBUTORS, INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZPEPTIC RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L&R DISTRIBUTORS, INC.]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKPEPTIC RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L&R DISTRIBUTORS, INC.]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPEPTIC RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L&R DISTRIBUTORS, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPEPTIC RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L&R DISTRIBUTORS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPEPTIC RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L&R DISTRIBUTORS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PEPTIC RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L&R DISTRIBUTORS, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APEPTIC RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L&R DISTRIBUTORS, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPEPTIC RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L&R DISTRIBUTORS, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPEPTIC RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L&R DISTRIBUTORS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPEPTIC RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L&R DISTRIBUTORS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPEPTIC RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L&R DISTRIBUTORS, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15127-319-01151270319015 POUCH in 1 CARTON (15127-319-01) > 6 TABLET, CHEWABLE in 1 POUCH5 pouch1998-07-162021-08-03NoNoCurrent