Peptic Relief

Product NDC
49580-0024
11-digit product format
495800024
Labeler code
49580
Product ID
49580-0024_b606950c-e034-433f-8fcf-2209293c2fba
Type
HUMAN OTC DRUG
Nonproprietary name
Maximum Strength Pepto Bismol
Dosage form
SUSPENSION
Route
ORAL
Labeler
P & L Development, LLC
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-12-11
Marketing end
2019-12-31
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/15mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49580-0024DDiscontinued by firm2026-10-05
excluded packagepackage49580-002449580-0024-8DDiscontinued 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 · 24 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 packagepackage49580-0024-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49580-0024-8f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49580-0024-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49580-0024-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49580-0024-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49580-0024-8cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49580-0024-8302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49580-0024-8ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49580-0024-80efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49580-0024-8ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49580-0024-8367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49580-0024-8557ba5c1ecfa…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 MAXIMUM STRENGTH (MAXIMUM STRENGTH PEPTO BISMOL) SUSPENSION [AARON INDUSTRIES, INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZPEPTIC RELIEF MAXIMUM STRENGTH (MAXIMUM STRENGTH PEPTO BISMOL) SUSPENSION [AARON INDUSTRIES, INC.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMPEPTIC RELIEF MAXIMUM STRENGTH (MAXIMUM STRENGTH PEPTO BISMOL) SUSPENSION [AARON INDUSTRIES, INC.]1
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RTPEPTIC RELIEF MAXIMUM STRENGTH (MAXIMUM STRENGTH PEPTO BISMOL) SUSPENSION [AARON INDUSTRIES, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPEPTIC RELIEF MAXIMUM STRENGTH (MAXIMUM STRENGTH PEPTO BISMOL) SUSPENSION [AARON INDUSTRIES, INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCPEPTIC RELIEF MAXIMUM STRENGTH (MAXIMUM STRENGTH PEPTO BISMOL) SUSPENSION [AARON INDUSTRIES, INC.]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JPEPTIC RELIEF MAXIMUM STRENGTH (MAXIMUM STRENGTH PEPTO BISMOL) SUSPENSION [AARON INDUSTRIES, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPEPTIC RELIEF MAXIMUM STRENGTH (MAXIMUM STRENGTH PEPTO BISMOL) SUSPENSION [AARON INDUSTRIES, INC.]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZPEPTIC RELIEF MAXIMUM STRENGTH (MAXIMUM STRENGTH PEPTO BISMOL) SUSPENSION [AARON INDUSTRIES, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BPEPTIC RELIEF MAXIMUM STRENGTH (MAXIMUM STRENGTH PEPTO BISMOL) SUSPENSION [AARON INDUSTRIES, INC.]1