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 3 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KaopectateBISMUTH SUBSALICYLATEKramer Laboratories3877a88d-9546-48ce-ad6b-3c2a115e3eaf2026-06-03WarningsExact identifier
application number: M008
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.f0976d6c-d574-49e8-b98a-23a660d83fa02026-06-02WarningsExact identifier
application number: M008
Stomach Relief Maximum StrengthBISMUTH SUBSALICYLATECVS Pharmacy9d8f2456-732d-40bf-a10c-98423560c0292026-05-13WarningsExact identifier
application number: M008
Green Guard Instydose Upset Stomach ReliefBISMUTH SUBSALICYLATEUnifirst First Aid Corporation5b1f31a9-8eec-4c3d-e063-6394a90a2efe2026-05-01WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)6f189c12-eb94-476e-a8f7-ea82f44c4aa52026-04-13WarningsExact identifier
application number: M008
Pepto BismolBISMUTH SUBSALICYLATENavajo Manufacturing Company Inc.033bccc6-6e81-487f-91fe-9d7cc465e1b22026-04-08WarningsExact identifier
application number: M008
SootheBISMUTH SUBSALICYLATEWalgreens450483c3-487f-4a8f-a439-5661241a8f0f2026-04-08WarningsExact identifier
application number: M008
GS Stomach ReliefBISMUTH SUBSALICYLATE 525 MGGood Sense (Geiss, Destin & Dunn, Inc.)edd15c7d-f66b-4b1a-8cda-9814a37904832026-03-31WarningsExact identifier
application number: M008
WALGREEN ULTRA STRENGTH PINK BISMUTHBISMUTH SUBSALICYLATEWALGREENS CO.d0f78754-2556-4aa8-949b-a6e3b4adf8c22026-03-25WarningsExact identifier
application number: M008
Dr. Simi Stomach ReliefBISMUTH SUBSALICYLATE 525 MGFarmacias De Similares TX LLC4dc9233e-68fb-e1e8-e063-6294a90aee332026-03-24WarningsExact identifier
application number: M008
Major Bismuth SubsalicylateBISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.69b9999f-c2e5-43a6-891f-0e24d3c343a42026-03-20WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEGrocery Outlet, Inc.4465dd17-c333-7b95-e063-6294a90a50532026-03-19WarningsExact identifier
application number: M008
AMAZON Regular StrengthBISMUTH SUBSALICYLATEAMAZON.COM SERVICES LLC6b41f36d-1810-45f7-a46c-67b9bff237382026-03-04WarningsExact identifier
application number: M008
AMAZON Digestive ReliefBISMUTH SUBSALICYLATEAMAZON.COM SERVICES LLCa9a676d8-06b9-43bf-9c06-08670c9ab2112026-03-04WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEWal-Mart Stores Inc2d7d563e-4c46-4788-b6a7-5b92e3d585332026-02-26WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEChain Drug Marketing Association, Inc.d63110ee-2d64-46dd-80bf-696c9b9d8d7c2026-02-26WarningsExact identifier
application number: M008
SIGNATURE CARE Ultra Strength StomachBISMUTH SUBSALICYLATESAFEWAY4b54fa21-d8ea-4497-aa32-17e47669c8e12026-02-20WarningsExact identifier
application number: M008
SIGNATURE CARE Regular StrengthBISMUTH SUBSALICYLATESAFEWAYb4643d99-90ce-4f00-a61a-a5371fe0f4242026-02-20WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEGrocery Outlet, Inc.44673b4f-1bf8-9db3-e063-6294a90a62f52026-02-14WarningsExact identifier
application number: M008
Treda UltraBISMUTH SUBSALICYLATELaboratorios Sanfer, S.A. de C.V.cfa7f37a-e18b-4929-b3a4-4126b0aa679a2026-02-12WarningsExact 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