FDA.reportPublic FDA data

Pepto Bismol

Product NDC
37000-535
11-digit product format
370000535
Labeler code
37000
Product ID
37000-535_5d1b51ad-dd9d-d4b1-e063-6394a90a8187
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-03-01
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
Liquicaps
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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-535-122021-02-12Pepto Bismol ® LiquiCaps
37000-535-122021-02-12Pepto Bismol ® LiquiCaps
37000-535-242021-02-12Pepto Bismol ® LiquiCaps
37000-535-242021-02-12Pepto Bismol ® LiquiCaps
37000-535-482021-02-12Pepto Bismol ® LiquiCaps
37000-535-482021-02-12Pepto Bismol ® LiquiCaps
37000-535-122021-01-29Pepto Bismol ® LiquiCaps
37000-535-122021-01-29Pepto Bismol ® LiquiCaps
37000-535-242021-01-29Pepto Bismol ® LiquiCaps
37000-535-242021-01-29Pepto Bismol ® LiquiCaps
37000-535-482021-01-29Pepto Bismol ® LiquiCaps
37000-535-482021-01-29Pepto Bismol ® LiquiCaps

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-535-12Pepto BismolLiquicaps12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1212
37000-535-12Pepto BismolLiquicaps1 in 1 CARTONCAPSULE, LIQUID FILLED112
37000-535-24Pepto BismolLiquicaps12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1212
37000-535-24Pepto BismolLiquicaps2 in 1 CARTONCAPSULE, LIQUID FILLED212
37000-535-48Pepto BismolLiquicaps12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1212
37000-535-48Pepto BismolLiquicaps4 in 1 CARTONCAPSULE, LIQUID FILLED412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-535PEPTO BISMOL LIQUICAPS (BISMUTH SUBSALICYLATE) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Current NDC, Legacy NDC, 6 package rows20241011_84ffa6d6-03e1-59e8-e053-2a91aa0afd6e.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
2121072bismuth subsalicylate 262 MG Oral CapsulePSN84ffa6d6-03e1-59e8-e053-2a91aa0afd6e12
2121074Pepto-Bismol 262 MG Oral CapsulePSN84ffa6d6-03e1-59e8-e053-2a91aa0afd6e12
2121074bismuth subsalicylate 262 MG Oral Capsule [Pepto-bismol]SBD84ffa6d6-03e1-59e8-e053-2a91aa0afd6e12
2121072bismuth subsalicylate 262 MG Oral CapsuleSCD84ffa6d6-03e1-59e8-e053-2a91aa0afd6e12
2121074Pepto-bismol 262 MG Oral CapsuleSY84ffa6d6-03e1-59e8-e053-2a91aa0afd6e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-535-12370000535121 BLISTER PACK in 1 CARTON (37000-535-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2019-03-010000-00-00NoNoCurrent
37000-535-24370000535242 BLISTER PACK in 1 CARTON (37000-535-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2019-03-010000-00-00NoNoCurrent
37000-535-48370000535484 BLISTER PACK in 1 CARTON (37000-535-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2019-03-010000-00-00NoNoCurrent