Pepto-Bismol

Product NDC
37000-476
11-digit product format
370000476
Labeler code
37000
Product ID
37000-476_eea2bc33-da26-66b8-e053-2995a90aafef
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M008
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2004-06-30
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37000-476DDiscontinued by firm2026-10-15
excluded packagepackage37000-47637000-476-01DDiscontinued by firm2026-10-15
excluded packagepackage37000-47637000-476-02DDiscontinued by firm2026-10-15
excluded packagepackage37000-47637000-476-03DDiscontinued by firm2026-10-15
excluded packagepackage37000-47637000-476-12DDiscontinued by firm2026-10-15

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 packagepackage37000-476-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37000-476-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37000-476-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37000-476-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37000-476-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37000-476-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37000-476-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37000-476-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37000-476-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37000-476-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37000-476-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37000-476-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37000-476-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37000-476-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37000-476-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37000-476-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37000-476-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37000-476-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37000-476-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37000-476-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37000-476-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37000-476-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37000-476-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37000-476-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37000-476-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37000-476-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37000-476-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37000-476-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37000-476-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37000-476-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37000-476-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37000-476-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37000-476-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37000-476-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37000-476-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37000-476-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37000-476-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37000-476-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37000-476-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37000-476-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37000-476-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37000-476-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37000-476-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37000-476-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37000-476-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37000-476-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37000-476-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37000-476-12557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-476-02EA - Each37000-47629cf9157-f172-435e-a630-d8b504d3135512015-10-02
37000-476-03EA - Each37000-476f48857f1-cfc1-43b9-b962-87c1e563058f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bismuth subsalicylateACTIVE INGREDIENT62TEY51RR1PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]1
Bismuth subsalicylateACTIVE MOIETY62TEY51RR1PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]1
calcium carbonateINACTIVE INGREDIENTH0G9379FGKPEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]1
magnesium stearateINACTIVE INGREDIENT70097M6I30PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]1
mannitolINACTIVE INGREDIENT3OWL53L36APEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]1
povidoneINACTIVE INGREDIENTFZ989GH94EPEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreen Stomach ReliefBISMUTH SUBSALICYLATEWALGREENS CO.53fdceb2-68ea-42b9-87eb-f202e96eb5242025-11-25WarningsExact identifier
application number: M008
WalgreenBISMUTH SUBSALICYLATEWALGREEN CO.73231515-840f-4086-86da-4b815d664c132025-11-25WarningsExact identifier
application number: M008
Percy MedicineBISMUTH SUBSALICYLATEMerrick Medicine Company, Inc08dd53b7-8345-4849-9155-60429cbe2c512025-11-11WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)d28ef2ae-2b0a-4f32-9bc1-6803806f3c812025-11-11WarningsExact identifier
application number: M008
TopCare Regular StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLC2619720a-d926-4b17-899c-54d49c78802c2025-11-10WarningsExact identifier
application number: M008
TopCare Stomach Relief Regular StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLCb93a0b38-eb5f-47c0-8112-75505e46f7c32025-11-10WarningsExact identifier
application number: M008
TopCare Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLCe745e693-9e45-43b0-b26c-99ca891b74b02025-11-10WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)6298b856-90ea-4054-bda3-70f92b14611d2025-11-10WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)61309786-96ee-4d9b-8dd3-8e4a91ebe88c2025-11-07WarningsExact identifier
application number: M008
up and up digestive reliefBISMUTH SUBSALICYLATETarget Corporation5731025d-ffaa-4b31-971f-e58b921e40ed2025-11-05WarningsExact identifier
application number: M008
ULTRA STRENGHT PINK BISMUTHBISMUTH SUBSALICYLATETARGET CORPORATION20063215-f657-487b-9530-6df0181b440a2025-11-05WarningsExact identifier
application number: M008
up and up 5-symptom digestive reliefBISMUTH SUBSALICYLATETarget Corporation7f6b2960-943d-464c-9ff9-4649a8ab4a4e2025-11-04WarningsExact identifier
application number: M008
up and up 5-symptom digestive reliefBISMUTH SUBSALICYLATETarget Corporation6462e224-5ee7-4556-90f2-994eaf89b71b2025-11-04WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATESAFEWAYba698d38-83f1-4257-9c43-e7a55dbb206e2025-10-29WarningsExact identifier
application number: M008
Digestive ReliefBISMUTH SUBSALICYLATESAFEWAY5538d56a-b258-4260-b51b-f5131bd768852025-10-29WarningsExact identifier
application number: M008
Chewable Stomach ReliefBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS INC,2a316e06-5c16-46b8-b9ac-71fe0f92c5152025-10-28WarningsExact identifier
application number: M008
PUBLIX Regular Strength Pink BismuthBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS, INCa9b2da55-5171-4702-9808-5b937182da022025-10-28WarningsExact identifier
application number: M008
PUBLIX Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS, INC4be86e84-fddf-4eb5-a519-64009d0e69fc2025-10-28WarningsExact identifier
application number: M008
Pepto-BismolBISMUTH SUBSALICYLATEASCLEMED USA INC.01b318d2-586d-4953-8f98-addc4e3cd4412025-10-15WarningsExact identifier
application number: M008
KaopectateBISMUTH SUBSALICYLATEKRAMER LABORATORIES18b79c8c-b2fd-449b-a154-7158c9b13cdd2025-10-15WarningsExact identifier
application number: M008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-476-01370000476011 BLISTER PACK in 1 POUCH (37000-476-01) > 2 TABLET in 1 BLISTER PACK1 blister pack2004-06-300000-00-00NoNoCurrent
37000-476-02370000476021 BOTTLE in 1 CARTON (37000-476-02) > 24 TABLET in 1 BOTTLE1 bottle2004-06-300000-00-00NoNoCurrent
37000-476-03370000476031 BOTTLE in 1 CARTON (37000-476-03) > 40 TABLET in 1 BOTTLE1 bottle2004-06-300000-00-00NoNoCurrent
37000-476-123700004761217852 TABLET in 1 BAG (37000-476-12) 17852 tablet2004-06-300000-00-00NoNoCurrent