FDA.reportPublic FDA data

Pepto Bismol

Product NDC
69423-963
11-digit product format
694230963
Labeler code
69423
Product ID
69423-963_5d1b7120-97c2-edc8-e063-6394a90a0e8f
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
69423-963-24Pepto BismolChews24 in 1 BOTTLE, PLASTICTABLET, CHEWABLE2414
69423-963-48Pepto BismolChews48 in 1 BOTTLE, PLASTICTABLET, CHEWABLE4814
69423-963-72Pepto BismolChews72 in 1 CELLO PACKTABLET, CHEWABLE7214
69423-963-72Pepto BismolChews24 in 1 BOTTLE, PLASTICTABLET, CHEWABLE2414

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-963PEPTO BISMOL CHEWS (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]11Current NDC, Legacy NDC, 4 package rows20250409_cfe9214d-25e9-7729-e053-2a95a90a0dfb.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
308761bismuth subsalicylate 262 MG Chewable TabletPSNcfe9214d-25e9-7729-e053-2a95a90a0dfb14
211151Pepto-Bismol 262 MG Chewable TabletPSNcfe9214d-25e9-7729-e053-2a95a90a0dfb14
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBDcfe9214d-25e9-7729-e053-2a95a90a0dfb14
308761bismuth subsalicylate 262 MG Chewable TabletSCDcfe9214d-25e9-7729-e053-2a95a90a0dfb14
211151Pepto-bismol 262 MG Chewable TabletSYcfe9214d-25e9-7729-e053-2a95a90a0dfb14
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSYcfe9214d-25e9-7729-e053-2a95a90a0dfb14
211151Pepto-Bismol To-Go 262 MG Chewable TabletSYcfe9214d-25e9-7729-e053-2a95a90a0dfb14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69423-963-246942309632424 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (69423-963-24) 2020-09-010000-00-00NoNoCurrent
69423-963-486942309634848 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (69423-963-48) 2025-12-01NoNoCurrent
69423-963-726942309637272 BOTTLE, PLASTIC in 1 CELLO PACK (69423-963-72) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2020-09-01NoNoCurrent