Pepto-Bismol

Product NDC
37000-032
11-digit product format
370000032
Labeler code
37000
Product ID
37000-032_6739d388-5325-4da8-e053-2991aa0aca5b
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
SUSPENSION
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1989-03-31
Marketing end
2019-10-10
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37000-032DDiscontinued by firm2026-10-05
excluded packagepackage37000-03237000-032-01DDiscontinued by firm2026-10-05
excluded packagepackage37000-03237000-032-02DDiscontinued by firm2026-10-05
excluded packagepackage37000-03237000-032-03DDiscontinued by firm2026-10-05
excluded packagepackage37000-03237000-032-04DDiscontinued 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 · 60 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 packagepackage37000-032-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37000-032-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37000-032-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37000-032-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37000-032-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37000-032-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37000-032-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37000-032-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37000-032-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37000-032-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37000-032-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37000-032-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37000-032-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37000-032-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37000-032-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37000-032-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37000-032-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37000-032-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37000-032-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37000-032-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37000-032-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37000-032-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37000-032-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37000-032-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37000-032-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37000-032-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37000-032-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37000-032-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37000-032-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37000-032-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37000-032-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37000-032-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37000-032-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37000-032-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37000-032-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37000-032-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37000-032-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37000-032-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37000-032-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37000-032-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37000-032-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37000-032-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37000-032-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37000-032-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37000-032-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37000-032-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37000-032-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37000-032-04557ba5c1ecfa…9c80585c8c6e…

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
37000-032-01ML - Milliliter37000-032da267f91-5557-440d-a2aa-49f44351201412012-07-24
37000-032-02ML - Milliliter37000-032ac909b91-80ff-44c7-ae3d-d2c393307e5212012-07-24
37000-032-03ML - Milliliter37000-032c596d31c-6bb1-4bd0-8ab0-502d1737159612012-07-24
37000-032-04ML - Milliliter37000-032b22f64e7-3583-4511-8810-e8c2a23d41c912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bismuth SubsalicylateACTIVE INGREDIENT62TEY51RR1PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
salicylic acidACTIVE MOIETYO414PZ4LPZPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
aluminum oxideINACTIVE INGREDIENTLMI26O6933PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
calcium carbonateINACTIVE INGREDIENTH0G9379FGKPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
D&C Red No. 22INACTIVE INGREDIENT1678RKX8RTPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
D&C Red No. 27INACTIVE INGREDIENT2LRS185U6KPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
magnesium stearateINACTIVE INGREDIENT70097M6I30PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
mannitolINACTIVE INGREDIENT3OWL53L36APEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
povidonesINACTIVE INGREDIENTFZ989GH94EPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
salicylic acidINACTIVE INGREDIENTO414PZ4LPZPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
sodium salicylateINACTIVE INGREDIENTWIQ1H85SYPPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
sorbic acidINACTIVE INGREDIENTX045WJ989BPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
talcINACTIVE INGREDIENT7SEV7J4R1UPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
waterINACTIVE INGREDIENT059QF0KO0RPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]3
Bismuth SubsalicylateACTIVE INGREDIENT62TEY51RR1PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
Salicylic AcidACTIVE MOIETYO414PZ4LPZPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
calcium carbonateINACTIVE INGREDIENTH0G9379FGKPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
D&C Red No. 22INACTIVE INGREDIENT1678RKX8RTPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
D&C Red No. 27INACTIVE INGREDIENT2LRS185U6KPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
magnesium stearateINACTIVE INGREDIENT70097M6I30PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
mannitolINACTIVE INGREDIENT3OWL53L36APEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
povidonesINACTIVE INGREDIENTFZ989GH94EPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
salicylic acidINACTIVE INGREDIENTO414PZ4LPZPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
sodium salicylateINACTIVE INGREDIENTWIQ1H85SYPPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
sorbic acidINACTIVE INGREDIENTX045WJ989BPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
talcINACTIVE INGREDIENT7SEV7J4R1UPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2
waterINACTIVE INGREDIENT059QF0KO0RPEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY]2