FDA.reportPublic FDA data

Pepto Bismol

Product NDC
85237-1903
11-digit product format
852371903
Labeler code
85237
Product ID
85237-1903_5611c6cb-5c0c-cf4e-e063-6394a90abff8
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Select Consumer Group
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
Brand name suffix
CHEWABLES
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
5611c6cb-5c0b-cf4e-e063-6394a90abff8Available on FDA.report

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 9 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Topcare Stomach Relief cherryBISMUTH SUBSALICYLATETopco Associates, LLC154b4b8f-c4d6-414b-aac3-88475669e19d2024-12-26WarningsExact identifier
application number: M008
Topco Stomach ReliefBISMUTH SUBSALICYLATETopco Associates, LLC7a5be682-f13b-41a4-bf8c-724bffab2e922024-12-26WarningsExact identifier
application number: M008
HEB Stomach Relief CherryBISMUTH SUBSALICYLATEH E B0277d4d7-c254-4eea-8f2e-4936d015a80f2024-12-26WarningsExact identifier
application number: M008
Equaline Maximum Strength Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFI716a7b86-4f6e-493d-ba29-d81f6ecafbf22024-12-20WarningsExact identifier
application number: M008
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFId0607a4e-de81-4881-abc7-cf0cc72a9f922024-12-20WarningsExact identifier
application number: M008
Guardian Pink BismuthBISMUTH SUBSALICYLATEGuardian Drug Company7e83fdf2-4007-46a8-ae9d-eab5a8ff19152024-12-18WarningsExact identifier
application number: M008
Stomach Relief, Caseys 4goodBISMUTH SUBSALICYLATE SUSPENSIONLil' Drug Store Products, Inc.030bb176-08ae-6c68-e063-6394a90af5272024-12-16WarningsExact identifier
application number: M008
Foster and Thrive Stomach ReliefBISMUTH SUBSALICYLATEStrategic Sourcing Services LLCc73c6650-a7ac-4942-ae07-0bc660a0081f2024-12-12WarningsExact identifier
application number: M008
Foster and Thrive Regular Strength Stomach Relief 527BISMUTH SUBSALICYLATE 525 MGStrategic Sourcing Services LLCf204f9ab-645b-4656-93a1-90aa4c3699222024-12-12WarningsExact identifier
application number: M008
Foster and Thrive Stomach ReliefBISMUTH SUBSALICYLATEStrategic Sourcing Services LLCd18cd615-912a-4853-bb2e-225960cfe08b2024-12-12WarningsExact identifier
application number: M008
Topcare Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATETopco Associates, LLC908da10c-2ed1-4917-a98b-bab63d7990d42024-12-09WarningsExact identifier
application number: M008
Careone Stomach ReliefBISMUTH SUBSALICYLATERetail Business Services, LLC.214f64c9-29e4-353d-e063-6294a90a12b42024-11-26WarningsExact identifier
application number: M008
Anti-DiarrhealBISMUTH SUBSALICYLATELil' Drug Store Products, Inc.079901b3-393b-44f0-85c9-2d8911f2a42a2024-11-25WarningsExact identifier
application number: M008
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCe91ed8a1-0d45-402c-9c16-1ae72e695a372024-11-20WarningsExact identifier
application number: M008
Rapidol Stomach ReliefBISMUTH SUBSALICYLATEPharmadel LLCefba1aea-f468-4f63-e053-2995a90a545b2024-11-18WarningsExact identifier
application number: M008
RITE AID Regular Strength Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION48fe12a5-5ff0-4d35-8708-675de32a9ed02024-10-31WarningsExact identifier
application number: M008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85237-1903-1852371903011 POUCH in 1 BLISTER PACK (85237-1903-1) / 2 TABLET, CHEWABLE in 1 POUCH (85237-1903-0) 1 pouch2025-07-02NoNoCurrent
85237-1903-2852371903022 POUCH in 1 BLISTER PACK (85237-1903-2) / 2 TABLET, CHEWABLE in 1 POUCH (85237-1903-0) 2 pouch2004-06-30NoNoCurrent
85237-1903-7852371903073 POUCH in 1 CARTON (85237-1903-7) / 2 TABLET, CHEWABLE in 1 POUCH (85237-1903-0) 3 pouch2025-07-08NoNoCurrent