Pepto-Bismol

Product NDC
37000-402
11-digit product format
370000402
Labeler code
37000
Product ID
37000-402_bb16a1ac-2e3a-1c7b-e053-2a95a90a3bda
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
KIT
Labeler
The Procter & Gamble Manufacturing Company
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-09-12
Marketing end
0000-00-00
Active strength
0
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37000-402DDiscontinued by firm2026-10-20
excluded packagepackage37000-40237000-402-01DDiscontinued by firm2026-10-20

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 packagepackage37000-402-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37000-402-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37000-402-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37000-402-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37000-402-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37000-402-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37000-402-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37000-402-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37000-402-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37000-402-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37000-402-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37000-402-01557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-402-012021-02-11C16284748780-1ba0f9c33-3cff-a910-e053-dadaa90a0b85Pepto-Bismol ™
37000-402-012021-01-29C16284748780-1ba0f9c33-3cff-a910-e053-dadaa90a0b85Pepto-Bismol ™

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-402-01370000402011 KIT in 1 PACKAGE (37000-402-01) * 473 mL in 1 BOTTLE, PLASTIC (37000-032-04) * 8 CELLO PACK in 1 CARTON (37000-477-10) > 6 TABLET in 1 CELLO PACK1 kit2011-09-120000-00-00NoNoCurrent