FDA.reportPublic FDA data

Pepto Bismol

Product NDC
37000-537
11-digit product format
370000537
Labeler code
37000
Product ID
37000-537_e4f32d6f-5f88-f7a8-e053-2995a90a4fee
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M008
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-03-01
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37000-537DDiscontinued by firm2026-10-15
excluded packagepackage37000-53737000-537-12DDiscontinued by firm2026-10-15
excluded packagepackage37000-53737000-537-24DDiscontinued by firm2026-10-15
excluded packagepackage37000-53737000-537-48DDiscontinued 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 · 11 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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-537-122021-02-12Pepto Bismol ® Diarrhea LiquiCaps
37000-537-242021-02-12Pepto Bismol ® Diarrhea LiquiCaps
37000-537-482021-02-12Pepto Bismol ® Diarrhea LiquiCaps
37000-537-122021-01-29Pepto Bismol ® Diarrhea LiquiCaps
37000-537-242021-01-29Pepto Bismol ® Diarrhea LiquiCaps
37000-537-482021-01-29Pepto Bismol ® Diarrhea LiquiCaps

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-537-12Pepto BismolDiarrhea Liquicaps1 in 1 CARTONCAPSULE, LIQUID FILLED110
37000-537-12Pepto BismolDiarrhea Liquicaps12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
37000-537-24Pepto BismolDiarrhea Liquicaps12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
37000-537-24Pepto BismolDiarrhea Liquicaps2 in 1 CARTONCAPSULE, LIQUID FILLED210
37000-537-48Pepto BismolDiarrhea Liquicaps12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
37000-537-48Pepto BismolDiarrhea Liquicaps4 in 1 CARTONCAPSULE, LIQUID FILLED410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-537PEPTO BISMOL DIARRHEA LIQUICAPS (BISMUTH SUBSALICYLATE) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Legacy NDC, 6 package rows20231129_851997d7-cb82-17bf-e053-2a91aa0ab78b.zip

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 8 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Stomach Relief cherryBISMUTH SUBSALICYLATETopco Associates, LLC154b4b8f-c4d6-414b-aac3-88475669e19d2024-12-26WarningsExact identifier
application number: M008
Topco Stomach ReliefBISMUTH SUBSALICYLATETopco Associates, LLC7a5be682-f13b-41a4-bf8c-724bffab2e922024-12-26WarningsExact identifier
application number: M008
HEB Stomach Relief CherryBISMUTH SUBSALICYLATEH E B0277d4d7-c254-4eea-8f2e-4936d015a80f2024-12-26WarningsExact identifier
application number: M008
Equaline Maximum Strength Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFI716a7b86-4f6e-493d-ba29-d81f6ecafbf22024-12-20WarningsExact identifier
application number: M008
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFId0607a4e-de81-4881-abc7-cf0cc72a9f922024-12-20WarningsExact identifier
application number: M008
Guardian Pink BismuthBISMUTH SUBSALICYLATEGuardian Drug Company7e83fdf2-4007-46a8-ae9d-eab5a8ff19152024-12-18WarningsExact identifier
application number: M008
Stomach Relief, Caseys 4goodBISMUTH SUBSALICYLATE SUSPENSIONLil' Drug Store Products, Inc.030bb176-08ae-6c68-e063-6394a90af5272024-12-16WarningsExact identifier
application number: M008
Foster and Thrive Stomach ReliefBISMUTH SUBSALICYLATEStrategic Sourcing Services LLCc73c6650-a7ac-4942-ae07-0bc660a0081f2024-12-12WarningsExact identifier
application number: M008
Foster and Thrive Regular Strength Stomach Relief 527BISMUTH SUBSALICYLATE 525 MGStrategic Sourcing Services LLCf204f9ab-645b-4656-93a1-90aa4c3699222024-12-12WarningsExact identifier
application number: M008
Foster and Thrive Stomach ReliefBISMUTH SUBSALICYLATEStrategic Sourcing Services LLCd18cd615-912a-4853-bb2e-225960cfe08b2024-12-12WarningsExact identifier
application number: M008
Topcare Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATETopco Associates, LLC908da10c-2ed1-4917-a98b-bab63d7990d42024-12-09WarningsExact identifier
application number: M008
Careone Stomach ReliefBISMUTH SUBSALICYLATERetail Business Services, LLC.214f64c9-29e4-353d-e063-6294a90a12b42024-11-26WarningsExact identifier
application number: M008
Anti-DiarrhealBISMUTH SUBSALICYLATELil' Drug Store Products, Inc.079901b3-393b-44f0-85c9-2d8911f2a42a2024-11-25WarningsExact identifier
application number: M008
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCe91ed8a1-0d45-402c-9c16-1ae72e695a372024-11-20WarningsExact identifier
application number: M008
Rapidol Stomach ReliefBISMUTH SUBSALICYLATEPharmadel LLCefba1aea-f468-4f63-e053-2995a90a545b2024-11-18WarningsExact identifier
application number: M008
RITE AID Regular Strength Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION48fe12a5-5ff0-4d35-8708-675de32a9ed02024-10-31WarningsExact identifier
application number: M008
Rite Aid Digestive ReliefBISMUTH SUBSALICYLATERITE AID CORPORATION816c4ec4-46d1-4e8e-ad91-a11946c487692024-10-30WarningsExact identifier
application number: M008
Rite Aid Stomach ReliefBISMUTH SUBSALICYLATERITE AID CORPORATIONe3d49cf7-922f-438f-bc62-487a9e4db0252024-10-30WarningsExact identifier
application number: M008
Rite Aid Stomach Relief Original FlavorBISMUTH SUBSALICYLATERITE AID CORPORATION5db6ad20-208e-4881-90fc-672762f70cca2024-10-30WarningsExact identifier
application number: M008
Rite Aid Regular Strngth Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION2c4acea0-dfa2-422d-a13f-17699de747e62024-10-30WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121072bismuth subsalicylate 262 MG Oral CapsulePSN851997d7-cb82-17bf-e053-2a91aa0ab78b10
2121074Pepto-Bismol 262 MG Oral CapsulePSN851997d7-cb82-17bf-e053-2a91aa0ab78b10
2121074bismuth subsalicylate 262 MG Oral Capsule [Pepto-bismol]SBD851997d7-cb82-17bf-e053-2a91aa0ab78b10
2121072bismuth subsalicylate 262 MG Oral CapsuleSCD851997d7-cb82-17bf-e053-2a91aa0ab78b10
2121074Pepto-bismol 262 MG Oral CapsuleSY851997d7-cb82-17bf-e053-2a91aa0ab78b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-537-12370000537121 BLISTER PACK in 1 CARTON (37000-537-12) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2019-03-010000-00-00NoNoCurrent
37000-537-24370000537242 BLISTER PACK in 1 CARTON (37000-537-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2019-03-010000-00-00NoNoCurrent
37000-537-48370000537484 BLISTER PACK in 1 CARTON (37000-537-48) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2019-03-010000-00-00NoNoCurrent