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 7 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revasol Peptic ReliefBISMUTH SUBSALICYLATERnv LLC30dc3a0a-3496-4bdf-e063-6394a90a62fd2025-03-21WarningsExact identifier
application number: M008
TopCare Bismuth Stomach ReliefBISMUTHTopCo308f4b2a-22ff-42b9-e063-6394a90acc752025-03-17WarningsExact identifier
application number: M008
Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEGuardian Drug Company25175eac-d15f-ce0d-e063-6394a90a06502025-03-10WarningsExact identifier
application number: M008
Pink Bismuth Regular StrengthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0c675e-72ce-4a22-e063-6394a90a3dff2025-02-27WarningsExact identifier
application number: M008
Pink BismuthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0ce5dd-9eb5-8568-e063-6394a90a1a292025-02-27WarningsExact identifier
application number: M008
Maximum Strength Pink BismuthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0d4508-e5a1-ba46-e063-6394a90aec2a2025-02-27WarningsExact identifier
application number: M008
Pink Bismuth OriginalBISMUTH SUBSALICYLATE 525 MGDiscount Drug Mart, Inc2e0cb7d7-4c4f-824a-e063-6394a90aa3a42025-02-27WarningsExact identifier
application number: M008
SIMETHICONESIMETHICONENuCare Pharmaceuticals,Inc.e07f6acc-1b75-d8eb-e053-2a95a90a7d9b2025-02-24WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEHarris Teeter, LLC2c51458b-869c-0283-e063-6394a90a4ff72025-02-12WarningsExact identifier
application number: M008
Max Strength Stomach ReliefBISMUTH SUBSALICYLATEHarris Teeter, LLC2c516139-0a6a-5ba6-e063-6394a90aa14a2025-02-12WarningsExact identifier
application number: M008
Bismuth SubsalicylateBISMUTH SUBSALICYLATELEADER/ Cardinal Health 110, Inc.d4af6694-910c-da17-e053-2995a90a84542025-02-11WarningsExact identifier
application number: M008
Regular Strength Stomach ReliefBISMUTH SUBSALICYLATEDOLGENCORP, INC.f2ec112f-213c-8a23-e053-2995a90a5f3f2025-02-10WarningsExact identifier
application number: M008
Maximum Strength Stomach ReliefBISMUTH SUBSALICYLATEGuardian Drug Companyaf899b52-7d8c-4485-9fb8-006dae53568a2025-02-10WarningsExact identifier
application number: M008
CVS Health Stomach Relief SOFTGELBISMUTH SUBSALICYLATECVS Pharmacy, Inc.273013b3-9f79-873d-e063-6394a90a66402025-01-24WarningsExact identifier
application number: M008
GNP Pink BismuthBISMUTH SUBSALICYLATEAmerisource Bergen9f5df648-298a-43e3-b250-8db6786fc93f2025-01-20WarningsExact identifier
application number: M008
Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATEReliable 1 Laboratories LLC2e40ffd8-1afa-43af-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M008
Equate Stomach ReliefBISMUTH SUBSALICYLATEWal-Mart Stores, Inc.1e8ae968-6d40-4ac7-9bce-01d086584b612025-01-09WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATECARDINAL HEALTH 110, LLC. DBA LEADERb38d815b-a249-46d1-a9d0-4e8efab3e56b2025-01-06WarningsExact identifier
application number: M008
Quality Choice Stomach Relief 528BISMUTH SUBSALICYLATEChain Drug Marketing Association Inc.e065320d-09ee-4ab8-868a-ab3b4239e3922025-01-03WarningsExact identifier
application number: M008
HEB Stomach ReliefBISMUTH SUBSALICYLATEH E Bfac642cf-f2f7-4857-b54f-82f1dcb400ab2024-12-26WarningsExact 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