FDA.reportPublic FDA data

Pepto-Bismol

Product NDC
58933-478
11-digit product format
589330478
Labeler code
58933
Product ID
58933-478_5d1b5bf2-cd94-caa8-e063-6294a90a0316
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
Procter & Gamble Manufactura, S. de R.L. de C.V.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-01
Substance
BISMUTH SUBSALICYLATE
Active strength
525 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
ULTRA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 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
58933-478-122021-06-10Pepto ® BISMOL™ ULTRA
58933-478-122021-06-10Pepto ® BISMOL™ ULTRA
58933-478-122021-06-10Pepto ® BISMOL™ ULTRA
58933-478-242021-06-10Pepto ® BISMOL™ ULTRA
58933-478-242021-06-10Pepto ® BISMOL™ ULTRA
58933-478-242021-06-10Pepto ® BISMOL™ ULTRA
58933-478-122021-01-29Pepto ® BISMOL™ ULTRA
58933-478-122021-01-29Pepto ® BISMOL™ ULTRA
58933-478-122021-01-29Pepto ® BISMOL™ ULTRA
58933-478-242021-01-29Pepto ® BISMOL™ ULTRA
58933-478-242021-01-29Pepto ® BISMOL™ ULTRA
58933-478-242021-01-29Pepto ® BISMOL™ ULTRA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-478-12Pepto-BismolULTRA12 in 1 BOTTLETABLET1210
58933-478-12Pepto-BismolULTRA1 in 1 CARTONTABLET110
58933-478-24Pepto-BismolULTRA1 in 1 CARTONTABLET110
58933-478-24Pepto-BismolULTRA24 in 1 BOTTLETABLET2410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-478PEPTO-BISMOL ULTRA (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURA, S. DE R.L. DE C.V.]9Current NDC, Legacy NDC, 4 package rows20241012_63283ebc-cff8-07d4-e053-2a91aa0a9de0.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
1998447bismuth subsalicylate 525 MG Oral TabletPSN63283ebc-cff8-07d4-e053-2a91aa0a9de010
1998449Pepto-Bismol ULTRA 525 MG Oral TabletPSN63283ebc-cff8-07d4-e053-2a91aa0a9de010
1998449bismuth subsalicylate 525 MG Oral Tablet [Pepto-bismol]SBD63283ebc-cff8-07d4-e053-2a91aa0a9de010
1998447bismuth subsalicylate 525 MG Oral TabletSCD63283ebc-cff8-07d4-e053-2a91aa0a9de010
1998449Pepto-bismol 525 MG Oral TabletSY63283ebc-cff8-07d4-e053-2a91aa0a9de010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58933-478-12589330478121 BOTTLE in 1 CARTON (58933-478-12) / 12 TABLET in 1 BOTTLE1 bottle2018-02-010000-00-00NoNoCurrent
58933-478-24589330478241 BOTTLE in 1 CARTON (58933-478-24) / 24 TABLET in 1 BOTTLE1 bottle2018-02-010000-00-00NoNoCurrent