FDA.reportPublic FDA data

Pepto-Bismol

Product NDC
58933-478
11-digit product format
589330478
Labeler code
58933
Product ID
58933-478_5d1b5bf2-cd94-caa8-e063-6294a90a0316
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
Procter & Gamble Manufactura, S. de R.L. de C.V.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-01
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Pepto-Bismol
Brand name suffix
ULTRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62TEY51RR1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1998447Internal RxNorm lookup
1998449Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63283ebc-cff8-07d4-e053-2a91aa0a9de0Available on FDA.report

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
58933-478-122021-06-10Pepto ® BISMOL™ ULTRA
58933-478-122021-06-10Pepto ® BISMOL™ ULTRA
58933-478-122021-06-10Pepto ® BISMOL™ ULTRA
58933-478-242021-06-10Pepto ® BISMOL™ ULTRA
58933-478-242021-06-10Pepto ® BISMOL™ ULTRA
58933-478-242021-06-10Pepto ® BISMOL™ ULTRA
58933-478-122021-01-29Pepto ® BISMOL™ ULTRA
58933-478-122021-01-29Pepto ® BISMOL™ ULTRA
58933-478-122021-01-29Pepto ® BISMOL™ ULTRA
58933-478-242021-01-29Pepto ® BISMOL™ ULTRA
58933-478-242021-01-29Pepto ® BISMOL™ ULTRA
58933-478-242021-01-29Pepto ® BISMOL™ ULTRA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-478-12Pepto-BismolULTRA12 in 1 BOTTLETABLET1210
58933-478-12Pepto-BismolULTRA1 in 1 CARTONTABLET110
58933-478-24Pepto-BismolULTRA1 in 1 CARTONTABLET110
58933-478-24Pepto-BismolULTRA24 in 1 BOTTLETABLET2410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-478PEPTO-BISMOL ULTRA (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURA, S. DE R.L. DE C.V.]9Current NDC, Legacy NDC, 4 package rows20241012_63283ebc-cff8-07d4-e053-2a91aa0a9de0.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1998447bismuth subsalicylate 525 MG Oral TabletPSN63283ebc-cff8-07d4-e053-2a91aa0a9de010
1998449Pepto-Bismol ULTRA 525 MG Oral TabletPSN63283ebc-cff8-07d4-e053-2a91aa0a9de010
1998449bismuth subsalicylate 525 MG Oral Tablet [Pepto-bismol]SBD63283ebc-cff8-07d4-e053-2a91aa0a9de010
1998447bismuth subsalicylate 525 MG Oral TabletSCD63283ebc-cff8-07d4-e053-2a91aa0a9de010
1998449Pepto-bismol 525 MG Oral TabletSY63283ebc-cff8-07d4-e053-2a91aa0a9de010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58933-478-12589330478121 BOTTLE in 1 CARTON (58933-478-12) / 12 TABLET in 1 BOTTLE1 bottle2018-02-010000-00-00NoNoCurrent
58933-478-24589330478241 BOTTLE in 1 CARTON (58933-478-24) / 24 TABLET in 1 BOTTLE1 bottle2018-02-010000-00-00NoNoCurrent