FDA.reportPublic FDA data

Pepto-Bismol

Product NDC
58933-477
Requested package NDC
58933-477-01
11-digit product format
589330477
Labeler code
58933
Product ID
58933-477_eeb3d0e2-fd96-3ad5-e053-2a95a90a3231
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
Procter & Gamble Manufactura S de RL de CV
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58933-47758933-477-01DDiscontinued 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 · 12 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…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
58933-477-012021-06-10Pepto-Bismol® Chewable Tablets
58933-477-092021-06-10Pepto-Bismol® Chewable Tablets
58933-477-102021-06-10Pepto-Bismol® Chewable Tablets
58933-477-122021-06-10Pepto-Bismol® Chewable Tablets
58933-477-242021-06-10Pepto-Bismol® Chewable Tablets
58933-477-012021-01-29Pepto-Bismol® Chewable Tablets
58933-477-092021-01-29Pepto-Bismol® Chewable Tablets
58933-477-102021-01-29Pepto-Bismol® Chewable Tablets
58933-477-122021-01-29Pepto-Bismol® Chewable Tablets
58933-477-242021-01-29Pepto-Bismol® Chewable Tablets

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 4 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dye Free Regular Strength Stomach ReliefBISMUTH SUBSALICYLATEWalmart Inc.46846abe-062d-a11f-e063-6294a90a73f32026-02-06WarningsExact identifier
application number: M008
Bismuth subsalicylateBISMUTH SUBSALICYLATESoftgel Healthcare Pvt Ltd18f59606-1498-bd0c-e063-6394a90a7df22026-01-27WarningsExact identifier
application number: M008
Stomach Relief, Ultra StrengthBISMUTH SUBSALICYLATEMarc Glassman, Inc.8e47d007-237c-45c7-88c5-83953a06e4bd2025-12-26WarningsExact identifier
application number: M008
Equate Bismuth Stomach Relief ChewBISMUTH SUBSALICYLATEWalmart09967ac3-0013-c6ea-e063-6294a90a38d42025-12-23WarningsExact identifier
application number: M008
Walgreens Bismuth Stomach ReliefBISMUTH SUBSALICYLATEWalgreens21db191a-89a4-9854-e063-6294a90adab72025-12-23WarningsExact identifier
application number: M008
Kaopectate Max Peppermint Flavor Anti DiarrhealBISMUTH SUBSALICYLATEKramer Laboratoriese7218045-a593-485b-a5ba-03f3b35cbec42025-12-19WarningsExact identifier
application number: M008
KaopectateBISMUTH SUBSALICYLATEKramer Laboratories2f6766a1-d775-40bf-a039-975ab47fcceb2025-12-19WarningsExact identifier
application number: M008
Kaopectate Peppermint Flavor Anti DiarrhealBISMUTH SUBSALICYLATEKramer Laboratories0316f469-e9fa-47c3-bb20-bd4588b40bcc2025-12-19WarningsExact identifier
application number: M008
Kaopectate Vanilla Flavor Anti DiarrhealBISMUTH SUBSALICYLATEKramer Laboratories3ad310c8-3dfa-4435-87bf-17f1c0a9ca452025-12-19WarningsExact identifier
application number: M008
Meijer Bismuth Stomach ReliefBISMUTHMeijer26a65c79-3bc1-a424-e063-6394a90a848e2025-12-18WarningsExact identifier
application number: M008
Stomach Relief, 24-7 Life by 7-ElevenBISMUTH SUBSALICYLATE TABLET TABLET, CHEWABLELil' Drug Store products, Inc.45c206c3-5fea-2d33-e063-6394a90aa10f2025-12-12WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATERite Aid Corporatione9f5b3c3-9585-448d-8134-2214b5d78db02025-12-10WarningsExact identifier
application number: M008
QC Stomach Relief Cherry FlavorBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)d019eef1-8817-4bd4-84cf-04fd6542ee1a2025-12-04WarningsExact identifier
application number: M008
QC Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)63f191f1-b29f-4842-9d80-ac43117c23612025-12-04WarningsExact identifier
application number: M008
QC Anti Diarrheal Vanilla Regular FlavorBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)02737763-eb98-401d-942c-186c401a2d312025-12-04WarningsExact identifier
application number: M008
Pink-BismuthBISMUTH SUBSALICYLATEGuardian Drug Companycb7da2b4-5e44-488b-a6e7-362e9b06c49c2025-12-03WarningsExact identifier
application number: M008
QC Pink BismuthBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f69f5164-f227-4527-ac1c-cda213b96b252025-12-03WarningsExact identifier
application number: M008
Walgreen Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATEWALGREENS CO.57e66873-ccbb-4ee1-bcb9-4925713793f72025-12-01WarningsExact identifier
application number: M008
Ultra Strength digestive reliefBISMUTH SUBSALICYLATEWALGREENS CO.756e7a47-7e14-4694-84fa-ca6396f7edcc2025-11-26WarningsExact identifier
application number: M008
WalgreenBISMUTH SUBSALICYLATEWALGREEN COMPANYe7878137-a640-4d48-a6d5-23975e8b064b2025-11-25WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN8e84b0e3-a872-5437-e053-2a95a90abd191
702384Pepto-Bismol 262 MG Oral TabletPSN8e84b0e3-a872-5437-e053-2a95a90abd191
702384bismuth subsalicylate 262 MG Oral Tablet [Pepto-bismol]SBD8e84b0e3-a872-5437-e053-2a95a90abd191
308760bismuth subsalicylate 262 MG Oral TabletSCD8e84b0e3-a872-5437-e053-2a95a90abd191
702384Pepto-bismol 262 MG Oral TabletSY8e84b0e3-a872-5437-e053-2a95a90abd191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58933-477-01589330477012 TABLET in 1 CELLO PACK (58933-477-01) 2 tablet2004-06-300000-00-00NoNoCurrent