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 10 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEP & L Development, LLC7a461b91-d11f-4cb9-be61-c7d91d2783022024-04-16WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEGobrands, Inc. (Goodnow)cd647eb7-6e03-415c-8249-89c126824d002024-04-03WarningsExact identifier
application number: M008
Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATECare One (Retail Business Services, LLC.)c443b640-18b0-4b7d-a13c-0accb915a8012024-03-05WarningsExact identifier
application number: M008
Stomach Relief - Regular StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.970b4118-2c2e-4806-8fe8-937ba06cf6e92023-12-30WarningsExact identifier
application number: M008
Stomach Relief, Maximum StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.cdd436f6-b769-49aa-9e6c-da512da9e6e32023-12-30WarningsExact identifier
application number: M008
Stomach Relief - Maximum StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.15cd9163-16d6-4332-9e26-77c05e0a26a72023-12-30WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEDemoulas Super Markets Inc9a95d198-f3ba-4bc3-a6f1-e065eb7e86f02023-12-29WarningsExact identifier
application number: M008
Stomach Relief Maximum StrengthBISMUTH SUBSALICYLATEDemoulas Super Markets Incb2d55045-d4a4-4167-a20c-42932f35bab22023-12-29WarningsExact identifier
application number: M008
STOMACH RELIEFBISMUTH SUBSALICYLATEConsumer Value Products, Inc.7526a3f2-ce7c-46c8-8ddf-1bcaf313876d2023-12-29WarningsExact identifier
application number: M008
Estomaquil PolvoBISMUTH SUBSALICYLATEProMex LLCcf94c99a-c489-45ec-bb13-3e6959e377de2023-11-29WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECare One (Retail Business Services, LLC.)3c53adaa-275f-4164-b21e-285e4f03433e2023-10-05WarningsExact identifier
application number: M008
Pepto-Bismol Chewable, TRAVEL BASIXBISMUTH SUBSALICYLATELil' Drug Store Products, Inc.dd2f2205-34d1-4960-bf37-bb8d534cd0e12023-10-03WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATECDMA- QCfe3cd0ce-933b-4ad3-a34f-c057a93561582021-06-16WarningsExact identifier
application number: M008
Topcare Stomach Relief Original StrengthBISMUTH SUBSALICYLATETopCo Associates, LLCe4b1929c-0967-44ea-8552-6549aa2a464e2018-12-14WarningsExact identifier
application number: M008
BismuthBISMUTH SUBSALICYLATEAllegiant Health015ca07a-f6b5-4741-a7b0-821cf6d4e4182018-11-07WarningsExact identifier
application number: M008
GastrobizBISMUTH SUBSALICYLATEAllegiant Healthaa516512-afd7-453f-9c73-5fa930cafac32018-09-11WarningsExact identifier
application number: M008
Pep TumBISMUTH SUBSALICYLATEFirst Aid Directbf966e9f-2f95-41cd-a6e5-b8eb521181d82017-12-22WarningsExact identifier
application number: M008
Bismuth ChewableBISMUTH SUBSALICYLATE 262 MGMarc Glassman, Inc.cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e2016-12-19WarningsExact 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