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 6 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECARDINAL HEALTH 110, LLC. DBA LEADER7d6047a9-5557-487a-ae06-f904dac626c92025-10-14WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEAtlantic Biologicals Corp401f8393-680c-e1a8-e063-6394a90a81ab2025-10-01WarningsExact identifier
application number: M008
First Aid Direct Peptum TabsBISMUTH SUBSALICYLATECintas Corpdd14cd57-3f7c-4634-9da9-6f83dc5bae122025-09-29WarningsExact identifier
application number: M008
RIGHT REMEDIES Stomach Relief BISMUTH SUBSALICYLATE 262 mg softgelBISMUTH SUBSALICYLATEStrive Pharmaceuticals Inc.0f271054-fa96-4475-8279-65f4565aba362025-09-22WarningsExact identifier
application number: M008
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEFSA Store Inc. (Caring Mill)fbabc313-600a-4722-9948-1a3e214140592025-09-18WarningsExact identifier
application number: M008
QUALITY CHOICE ULTRA STRENGTH STOMACH RELIEFBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)67c610b1-fe94-4ad3-ad1a-8bd93a4da9d92025-09-11WarningsExact identifier
application number: M008
Medique DiotameBISMUTH SUBSALICYLATEUnifirst First Aid Corporation0667ec26-c2cd-153c-e054-00144ff88e882025-09-08WarningsExact identifier
application number: M008
McKesson BismuthBISMUTH SUBSALICYLATEMcKesson Medical-Surgicald1f3dfa4-e021-6384-e053-2995a90a7b422025-09-08WarningsExact identifier
application number: M008
Medi-First Pep-T-MedBISMUTH SUBSALICYLATEUnifirst First Aid Corporation88f4d5d4-92ed-40ab-97a9-181da72f869b2025-09-08WarningsExact identifier
application number: M008
Thompson Chewable Bismuth TabsBISMUTH SUBSALICYLATEThompson Safety LLCc94b9bc2-b764-a9a7-e053-2a95a90aed812025-09-08WarningsExact identifier
application number: M008
Goodsense Regular strength Stomach Relief 122BISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.f0588ab8-d1fc-419a-8d68-bee42332d50f2025-08-01WarningsExact identifier
application number: M008
Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATE 525 MGRetail Business Services, LLC.338ca589-91ff-30ed-e063-6294a90a243a2025-07-21WarningsExact identifier
application number: M008
Regular Strength Stomach ReliefBISMUTH SUBSALICYLATE 525 MGRetail Business Services, LLC.338d61af-35a8-fba7-e063-6294a90a38e82025-07-21WarningsExact identifier
application number: M008
SennaSENNOSIDESMajor Pharmaceuticalscfb6bf89-c77e-4372-9bc9-44d6a659c9552025-07-18WarningsExact identifier
application number: M008
Major Bismuth SubsalicylateBISMUTH SUBSALICYLATEMajor Pharmaceuticals2a7c9cc1-206e-4018-b89d-7b634df43df62025-07-11WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55440401-f82f-45a3-ba7e-6ccdfdacead32025-07-10WarningsExact identifier
application number: M008
Upset Stomach Relief-Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATE 262 MGPioneer Life Sciences, LLC07e2cc82-ab0e-46c5-863b-67658b6126782025-06-27WarningsExact identifier
application number: M008
Upset Stomach Relief-Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATE 262 MGNUVICARE LLC6697e464-00ac-41de-a7ea-d7bb24ed5e2a2025-06-25WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEP & L Development, LLC8383945f-b3a7-4242-bfaa-acf24b66406d2025-05-30WarningsExact identifier
application number: M008
5-Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION28fba615-48ca-8d96-e063-6394a90a27972025-04-12WarningsExact 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