FDA.reportPublic FDA data

Pepto-Bismol

Product NDC
58933-476
11-digit product format
589330476
Labeler code
58933
Product ID
58933-476_5d1b5b45-8c0d-dc41-e063-6394a90a8dec
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
Procter & Gamble Manufactura S de RL de CV
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-06-30
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
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
58933-476-012021-06-10Pepto BISMOL ® Caplets
58933-476-012021-06-10Pepto BISMOL ® Caplets
58933-476-012021-06-10Pepto BISMOL ® Caplets
58933-476-022021-06-10Pepto BISMOL ® Caplets
58933-476-022021-06-10Pepto BISMOL ® Caplets
58933-476-022021-06-10Pepto BISMOL ® Caplets
58933-476-032021-06-10Pepto BISMOL ® Caplets
58933-476-032021-06-10Pepto BISMOL ® Caplets
58933-476-032021-06-10Pepto BISMOL ® Caplets
58933-476-122021-06-10Pepto BISMOL ® Caplets
58933-476-122021-06-10Pepto BISMOL ® Caplets
58933-476-122021-06-10Pepto BISMOL ® Caplets
58933-476-012021-01-29Pepto BISMOL ® Caplets
58933-476-012021-01-29Pepto BISMOL ® Caplets
58933-476-012021-01-29Pepto BISMOL ® Caplets
58933-476-022021-01-29Pepto BISMOL ® Caplets
58933-476-022021-01-29Pepto BISMOL ® Caplets
58933-476-022021-01-29Pepto BISMOL ® Caplets
58933-476-032021-01-29Pepto BISMOL ® Caplets
58933-476-032021-01-29Pepto BISMOL ® Caplets
58933-476-032021-01-29Pepto BISMOL ® Caplets
58933-476-122021-01-29Pepto BISMOL ® Caplets
58933-476-122021-01-29Pepto BISMOL ® Caplets
58933-476-122021-01-29Pepto BISMOL ® Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-476-01Pepto-Bismol1 in 1 POUCHTABLET19
58933-476-01Pepto-Bismol2 in 1 BLISTER PACKTABLET29
58933-476-02Pepto-Bismol24 in 1 BOTTLETABLET249
58933-476-02Pepto-Bismol1 in 1 CARTONTABLET19
58933-476-03Pepto-Bismol40 in 1 BOTTLETABLET409
58933-476-03Pepto-Bismol1 in 1 CARTONTABLET19
58933-476-12Pepto-Bismol17852 in 1 BAGTABLET178529

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-476PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURA S DE RL DE CV]8Current NDC, Legacy NDC, 7 package rows20241012_66d9d631-ba73-3ce4-e053-2a91aa0a1cc4.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 2 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WinCo FOODS Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODSacf82012-0e40-4d50-b1f1-f36dc3dfad842026-08-07WarningsExact identifier
application number: M008
WinCo FOODS Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODS19c14efc-bf5f-4ef5-a727-aaccfae093f02026-08-07WarningsExact identifier
application number: M008
WinCo FOODS Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODS LLC53ae695d-f812-462d-9487-8fb5db0aa27d2026-08-07WarningsExact identifier
application number: M008
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp212ccf1f-faaf-4f77-9722-28713fc427612026-08-05WarningsExact identifier
application number: M008
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp7c0ca713-643a-46bd-9d9a-21ac39c808c42026-08-05WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEShield Pharmaceuticals Corp8177318d-427b-4bfc-9d7f-51d1545f4eb82026-07-27WarningsExact identifier
application number: M008
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4b20f189-e979-8198-e063-6294a90a71692026-07-16WarningsExact identifier
application number: M008
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4bd5aa23-37aa-b818-e063-6394a90ae06c2026-07-15WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEWALMART INC. (see also Equate)369fe912-dd0e-4ff3-a597-5ee81332838a2026-07-15WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)642c14bd-be99-410b-9ba7-6e71c97052302026-07-15WarningsExact identifier
application number: M008
Good Neighbor Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEAMERISOURCE BERGEN71c30b10-db24-4a42-a4f4-db552e3d5fe62026-07-13WarningsExact identifier
application number: M008
Pepto Bismol CHEWABLESBISMUTH SUBSALICYLATESelect Consumer Group5611c6cb-5c0b-cf4e-e063-6394a90abff82026-07-07WarningsExact identifier
application number: M008
Green Guard Instydose Mucus ReliefGUAIFENESINUnifirst First Aid Corporation5b21bd13-d649-6570-e063-6394a90a51e92026-07-01WarningsExact identifier
application number: M008
Medique Guaicon InsydoseGUAIFENESINUnifirst First Aid Corporation5b230d04-3cf2-51e0-e063-6294a90a24982026-07-01WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATERugby Laboratories6166c04e-20c6-4678-b16d-5174744456982026-06-26WarningsExact identifier
application number: M008
Stomach Relief regular strengthBISMUTH SUBSALICYLATECVS Pharmacy1aa386ac-8ffd-4ba4-9b2e-19156d374c482026-06-25WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEWalgreensc367d913-e37b-467a-84da-dd6a22c793ae2026-06-25WarningsExact identifier
application number: M008
Bismuth Subsalicylate Pink BismuthBISMUTH SUBSALICYLATEHyvee Inc4e575573-9ded-bfbf-e063-6394a90aed3b2026-06-23WarningsExact identifier
application number: M008
Stomach relieverBISMUTH SUBSALICYLATEHyvee Inc44ead6e1-cd88-4602-e063-6394a90aed9f2026-06-16WarningsExact identifier
application number: M008
Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.f7627bf1-da97-4875-b614-5029663f74822026-06-08WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN66d9d631-ba73-3ce4-e053-2a91aa0a1cc49
702384Pepto-Bismol 262 MG Oral TabletPSN66d9d631-ba73-3ce4-e053-2a91aa0a1cc49
702384bismuth subsalicylate 262 MG Oral Tablet [Pepto-bismol]SBD66d9d631-ba73-3ce4-e053-2a91aa0a1cc49
308760bismuth subsalicylate 262 MG Oral TabletSCD66d9d631-ba73-3ce4-e053-2a91aa0a1cc49
702384Pepto-bismol 262 MG Oral TabletSY66d9d631-ba73-3ce4-e053-2a91aa0a1cc49
308760bismuth subsalicylate 262 MG Oral TabletPSN01b318d2-586d-4953-8f98-addc4e3cd4411
702384Pepto-Bismol 262 MG Oral TabletPSN01b318d2-586d-4953-8f98-addc4e3cd4411
702384bismuth subsalicylate 262 MG Oral Tablet [Pepto-bismol]SBD01b318d2-586d-4953-8f98-addc4e3cd4411
308760bismuth subsalicylate 262 MG Oral TabletSCD01b318d2-586d-4953-8f98-addc4e3cd4411
702384Pepto-bismol 262 MG Oral TabletSY01b318d2-586d-4953-8f98-addc4e3cd4411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58933-476-01589330476011 BLISTER PACK in 1 POUCH (58933-476-01) / 2 TABLET in 1 BLISTER PACK1 blister pack2004-06-300000-00-00NoNoCurrent
58933-476-02589330476021 BOTTLE in 1 CARTON (58933-476-02) / 24 TABLET in 1 BOTTLE1 bottle2004-06-300000-00-00NoNoCurrent
58933-476-03589330476031 BOTTLE in 1 CARTON (58933-476-03) / 40 TABLET in 1 BOTTLE1 bottle2004-06-300000-00-00NoNoCurrent
58933-476-125893304761217852 TABLET in 1 BAG (58933-476-12) 17852 tablet2004-06-300000-00-00NoNoCurrent