FDA.reportPublic FDA data

Pepto Bismol

Product NDC
67751-155
Requested package NDC
67751-155-01
11-digit product format
677510155
Labeler code
67751
Product ID
67751-155_4efb4585-b90f-f303-e063-6294a90a4ba6
Type
HUMAN OTC DRUG
Nonproprietary name
BISMUTH SUBSALICYLATE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-20
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67751-15567751-155-01IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62TEY51RR1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
211151Internal RxNorm lookup
308761Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
033bccc6-6e81-487f-91fe-9d7cc465e1b2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
67751-155-012024-04-15Pepto Bismol
67751-155-022024-04-15Pepto Bismol
67751-155-012023-01-30Pepto Bismol
67751-155-022023-01-30Pepto Bismol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-155-01Pepto Bismol1 in 1 CARTONTABLET, CHEWABLE14
67751-155-01Pepto Bismol2 in 1 POUCHTABLET, CHEWABLE24
67751-155-02Pepto Bismol1 in 1 CARTONTABLET, CHEWABLE14
67751-155-02Pepto Bismol4 in 1 POUCHTABLET, CHEWABLE44
67751-155-06Pepto Bismol2 in 1 POUCHTABLET, CHEWABLE24
67751-155-06Pepto Bismol3 in 1 CARTONTABLET, CHEWABLE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-155PEPTO BISMOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [NAVAJO MANUFACTURING COMPANY INC.]3Current NDC, Legacy NDC, 6 package rows20240417_033bccc6-6e81-487f-91fe-9d7cc465e1b2.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
308761bismuth subsalicylate 262 MG Chewable TabletPSN033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151Pepto-Bismol 262 MG Chewable TabletPSN033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBD033bccc6-6e81-487f-91fe-9d7cc465e1b24
308761bismuth subsalicylate 262 MG Chewable TabletSCD033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151Pepto-bismol 262 MG Chewable TabletSY033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSY033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151Pepto-Bismol To-Go 262 MG Chewable TabletSY033bccc6-6e81-487f-91fe-9d7cc465e1b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-155-01677510155011 POUCH in 1 CARTON (67751-155-01) / 2 TABLET, CHEWABLE in 1 POUCH1 pouch2016-09-200000-00-00NoNoCurrent