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 6 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach ReliefBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)61309786-96ee-4d9b-8dd3-8e4a91ebe88c2025-11-07WarningsExact identifier
application number: M008
up and up digestive reliefBISMUTH SUBSALICYLATETarget Corporation5731025d-ffaa-4b31-971f-e58b921e40ed2025-11-05WarningsExact identifier
application number: M008
ULTRA STRENGHT PINK BISMUTHBISMUTH SUBSALICYLATETARGET CORPORATION20063215-f657-487b-9530-6df0181b440a2025-11-05WarningsExact identifier
application number: M008
up and up 5-symptom digestive reliefBISMUTH SUBSALICYLATETarget Corporation7f6b2960-943d-464c-9ff9-4649a8ab4a4e2025-11-04WarningsExact identifier
application number: M008
up and up 5-symptom digestive reliefBISMUTH SUBSALICYLATETarget Corporation6462e224-5ee7-4556-90f2-994eaf89b71b2025-11-04WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATESAFEWAYba698d38-83f1-4257-9c43-e7a55dbb206e2025-10-29WarningsExact identifier
application number: M008
Digestive ReliefBISMUTH SUBSALICYLATESAFEWAY5538d56a-b258-4260-b51b-f5131bd768852025-10-29WarningsExact identifier
application number: M008
Chewable Stomach ReliefBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS INC,2a316e06-5c16-46b8-b9ac-71fe0f92c5152025-10-28WarningsExact identifier
application number: M008
PUBLIX Regular Strength Pink BismuthBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS, INCa9b2da55-5171-4702-9808-5b937182da022025-10-28WarningsExact identifier
application number: M008
PUBLIX Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS, INC4be86e84-fddf-4eb5-a519-64009d0e69fc2025-10-28WarningsExact identifier
application number: M008
meijer stomach reliefBISMUTH SUBSALICYLATEMeijer Distribution Inc3803eb97-4d12-4e5d-9a62-f84cc10266762025-10-24WarningsExact identifier
application number: M008
meijer stomach reliefBISMUTH SUBSALICYLATEMeijer Distribution Inc9d136004-d55d-40aa-9f4f-d366ac5d08652025-10-24WarningsExact identifier
application number: M008
meijer stomach relief regular strengthBISMUTH SUBSALICYLATEMEIJER DISTRIBUTION INC2b85bf5f-1717-42db-b546-dddfdc7d158d2025-10-24WarningsExact identifier
application number: M008
meijer stomach relief regular strengthBISMUTH SUBSALICYLATEMEIJER DISTRIBUTION INC9f20351e-efe2-492f-8ce1-b705d2eea6942025-10-24WarningsExact identifier
application number: M008
Meijer Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEMEIJER DISTRIBUTION INC0bc058fe-1784-4ae2-b686-01b8aebe058c2025-10-24WarningsExact identifier
application number: M008
Pepto-BismolBISMUTH SUBSALICYLATEASCLEMED USA INC.01b318d2-586d-4953-8f98-addc4e3cd4412025-10-15WarningsExact identifier
application number: M008
KaopectateBISMUTH SUBSALICYLATEKRAMER LABORATORIES18b79c8c-b2fd-449b-a154-7158c9b13cdd2025-10-15WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECARDINAL HEALTH 110, LLC. DBA LEADER7d6047a9-5557-487a-ae06-f904dac626c92025-10-14WarningsExact identifier
application number: M008
Pepto-BismolBISMUTH SUBSALICYLATEProcter & Gamble Manufactura S de RL de CV66d9d631-ba73-3ce4-e053-2a91aa0a1cc42025-10-09WarningsExact identifier
application number: M008
Pepto-Bismol ULTRABISMUTH SUBSALICYLATEProcter & Gamble Manufactura, S. de R.L. de C.V.63283ebc-cff8-07d4-e053-2a91aa0a9de02025-10-09WarningsExact 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