FDA.reportPublic FDA data

Pepto Bismol

Product NDC
37000-996
11-digit product format
370000996
Labeler code
37000
Product ID
37000-996_5d1b6864-df3b-da66-e063-6294a90a09d9
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-01
Substance
BISMUTH SUBSALICYLATE
Active strength
262 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
Chews
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-996-24Pepto BismolChews24 in 1 BOTTLE, PLASTICTABLET, CHEWABLE2411
37000-996-72Pepto BismolChews24 in 1 BOTTLE, PLASTICTABLET, CHEWABLE2411
37000-996-72Pepto BismolChews3 in 1 CELLO PACKTABLET, CHEWABLE311

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-996PEPTO BISMOL CHEWS (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]9Current NDC, Legacy NDC, 3 package rows20250323_bb8d2ed8-54a2-2295-e053-2995a90a10ac.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
308761bismuth subsalicylate 262 MG Chewable TabletPSNbb8d2ed8-54a2-2295-e053-2995a90a10ac11
211151Pepto-Bismol 262 MG Chewable TabletPSNbb8d2ed8-54a2-2295-e053-2995a90a10ac11
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBDbb8d2ed8-54a2-2295-e053-2995a90a10ac11
308761bismuth subsalicylate 262 MG Chewable TabletSCDbb8d2ed8-54a2-2295-e053-2995a90a10ac11
211151Pepto-bismol 262 MG Chewable TabletSYbb8d2ed8-54a2-2295-e053-2995a90a10ac11
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSYbb8d2ed8-54a2-2295-e053-2995a90a10ac11
211151Pepto-Bismol To-Go 262 MG Chewable TabletSYbb8d2ed8-54a2-2295-e053-2995a90a10ac11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37000-996-243700009962424 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (37000-996-24) 2020-09-010000-00-00NoNoCurrent
37000-996-72370000996723 BOTTLE, PLASTIC in 1 CELLO PACK (37000-996-72) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2020-09-010000-00-00NoNoCurrent