FDA.reportPublic FDA data

Pepto-Bismol

Product NDC
58933-391
11-digit product format
589330391
Labeler code
58933
Product ID
58933-391_eed9d0dd-f53d-35bf-e053-2a95a90a73a7
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
Procter & Gamble Manufacturing M
Application
M008
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-03-01
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
525 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58933-391DDiscontinued by firm2026-10-15
excluded packagepackage58933-39158933-391-12DDiscontinued by firm2026-10-15

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58933-391-122021-06-10C16284748780-1ba0f9c33-10b7-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea Caplets
58933-391-122021-01-29C16284748780-1ba0f9c33-10b7-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-391-12Pepto-BismolDiarrhea12 in 1 BOTTLETABLET127
58933-391-12Pepto-BismolDiarrhea1 in 1 CARTONTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-391PEPTO-BISMOL DIARRHEA (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING MÉXICO, S. DE R.L. DE C.V.]7Legacy NDC, 2 package rows20241012_84ef6f9a-ba4e-66b1-e053-2991aa0a0c34.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 9 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RITE AID Ultra Strnght Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION3ffb2bb9-6d6a-4c38-ac59-0ac0d754de282024-10-30WarningsExact identifier
application number: M008
Premier Value Diarrhea Relief Vanilla FlavorBISMUTH SUBSALICYLATEPHARMACY VALUE ALLIANCE, LLC1c6e464c-d5c6-4658-a0d8-bba87369a0c32024-10-28WarningsExact identifier
application number: M008
Premier ValueBISMUTH SUBSALICYLATECHAIN DRUG CONSORTIUM,LLC3b8850e8-f9c2-4d52-aadd-8e037fabdee42024-10-28WarningsExact identifier
application number: M008
Goodsense maximum strength Stomach Relief 528BISMUTH SUBSALICYLATEGood Sense (Geiss, Destin & Dunn, Inc.)19a4191a-6196-f8ac-e063-6394a90a47ab2024-09-17WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEBest Choice (Valu Merchandisers Company)5ecc500c-12d0-41dd-acb4-9190023c9ed52024-09-16WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEBest Choice (Valu Merchandisers Company)ecbf9caf-b02b-434e-8f29-50839010e8212024-09-16WarningsExact identifier
application number: M008
Goodsense Regular strength Stomach Relief 122BISMUTH SUBSALICYLATEGood Sense (Geiss, Destin & Dunn, Inc.)19a324bd-fa54-b899-e063-6394a90aaa732024-09-10WarningsExact identifier
application number: M008
Ultra BismuthBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0fc01a1a-4b1d-4c78-9955-220984a8019c2024-08-30WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)b22e1a0f-9866-403b-93e8-6e0e4130a75e2024-08-29WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATERugby Laboratories, Inc.87394088-1d2e-4ca4-bbfe-1481c9d4a3ba2024-08-29WarningsExact identifier
application number: M008
SootheBISMUTH SUBSALICYLATEWalgreensa2b2b0ce-034e-4857-bfca-0087bb31878e2024-07-25WarningsExact identifier
application number: M008
5-Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION07aa10e2-dd03-f32d-e063-6294a90aad0d2024-06-26WarningsExact identifier
application number: M008
Stomach ReliefSTOMACH RELIEFChain Drug Marketing Association, Inc.459abf99-63e8-43d7-a13c-9e46826984152024-06-21WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEStrategic Sourcing Services LLC2a018350-da22-4997-9181-661bb920afd32024-06-04WarningsExact identifier
application number: M008
5 Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION07a932fb-38eb-4b35-e063-6394a90ad61f2024-05-25WarningsExact identifier
application number: M008
Soothe Ultra StrengthBISMUTH SUBSALICYLATEWalgreensec96e6f2-b087-457e-9b95-30f3595deebb2024-05-21WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATESafeway, Inc.2bde4e41-ffbd-4d9d-ae00-e39a5c7264b32024-05-15WarningsExact identifier
application number: M008
Ultra Stomach ReliefBISMUTH SUBSALICYLATESafeway, Inc.71ca1c0e-50dc-4970-ae0d-5f7be1eec6df2024-05-15WarningsExact identifier
application number: M008
PEPT-ACHEBISMUTH SUBSALICYLATEJHK Inc dba American Safety & First Aid894c1912-cd24-4ddf-b7e7-dae9dd64b2802024-04-24WarningsExact identifier
application number: M008
Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATEP & L Development, LLCcb5ca7ab-39cf-4b07-ac22-a00b214db1022024-04-16WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1998447bismuth subsalicylate 525 MG Oral TabletPSN84ef6f9a-ba4e-66b1-e053-2991aa0a0c347
1998449Pepto-Bismol ULTRA 525 MG Oral TabletPSN84ef6f9a-ba4e-66b1-e053-2991aa0a0c347
1998449bismuth subsalicylate 525 MG Oral Tablet [Pepto-bismol]SBD84ef6f9a-ba4e-66b1-e053-2991aa0a0c347
1998447bismuth subsalicylate 525 MG Oral TabletSCD84ef6f9a-ba4e-66b1-e053-2991aa0a0c347
1998449Pepto-bismol 525 MG Oral TabletSY84ef6f9a-ba4e-66b1-e053-2991aa0a0c347

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58933-391-12589330391121 BOTTLE in 1 CARTON (58933-391-12) > 12 TABLET in 1 BOTTLE1 bottle2019-03-010000-00-00NoNoCurrent