FDA.reportPublic FDA data

Pepto Bismol

Product NDC
58933-002
11-digit product format
589330002
Labeler code
58933
Product ID
58933-002_5d1b6864-df3a-da66-e063-6294a90a09d9
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Procter & Gamble Manufactura S de RL de CV
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-01
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
CHEWABLES
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-002-12Pepto BismolCHEWABLES2 in 1 CELLO PACKTABLET, CHEWABLE21
58933-002-12Pepto BismolCHEWABLES6 in 1 CARTONTABLET, CHEWABLE61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-002PEPTO BISMOL CHEWABLES (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [PROCTER & GAMBLE MANUFACTURA S DE RL DE CV]1Current NDC, 2 package rows20250402_30b6adb2-48da-875b-e063-6394a90a593b.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 TabletPSN30b6adb2-48da-875b-e063-6394a90a593b1
211151Pepto-Bismol 262 MG Chewable TabletPSN30b6adb2-48da-875b-e063-6394a90a593b1
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBD30b6adb2-48da-875b-e063-6394a90a593b1
308761bismuth subsalicylate 262 MG Chewable TabletSCD30b6adb2-48da-875b-e063-6394a90a593b1
211151Pepto-bismol 262 MG Chewable TabletSY30b6adb2-48da-875b-e063-6394a90a593b1
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSY30b6adb2-48da-875b-e063-6394a90a593b1
211151Pepto-Bismol To-Go 262 MG Chewable TabletSY30b6adb2-48da-875b-e063-6394a90a593b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58933-002-12589330002126 CELLO PACK in 1 CARTON (58933-002-12) / 2 TABLET, CHEWABLE in 1 CELLO PACK6 cello pack2025-04-01NoNoCurrent