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 10 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Digestive ReliefBISMUTH SUBSALICYLATERITE AID CORPORATION816c4ec4-46d1-4e8e-ad91-a11946c487692024-10-30WarningsExact identifier
application number: M008
Rite Aid Stomach ReliefBISMUTH SUBSALICYLATERITE AID CORPORATIONe3d49cf7-922f-438f-bc62-487a9e4db0252024-10-30WarningsExact identifier
application number: M008
Rite Aid Stomach Relief Original FlavorBISMUTH SUBSALICYLATERITE AID CORPORATION5db6ad20-208e-4881-90fc-672762f70cca2024-10-30WarningsExact identifier
application number: M008
Rite Aid Regular Strngth Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION2c4acea0-dfa2-422d-a13f-17699de747e62024-10-30WarningsExact identifier
application number: M008
RITE AID Ultra Strnght Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION3ffb2bb9-6d6a-4c38-ac59-0ac0d754de282024-10-30WarningsExact identifier
application number: M008
Premier Value Diarrhea Relief Vanilla FlavorBISMUTH SUBSALICYLATEPHARMACY VALUE ALLIANCE, LLC1c6e464c-d5c6-4658-a0d8-bba87369a0c32024-10-28WarningsExact identifier
application number: M008
Premier ValueBISMUTH SUBSALICYLATECHAIN DRUG CONSORTIUM,LLC3b8850e8-f9c2-4d52-aadd-8e037fabdee42024-10-28WarningsExact identifier
application number: M008
Goodsense maximum strength Stomach Relief 528BISMUTH SUBSALICYLATEGood Sense (Geiss, Destin & Dunn, Inc.)19a4191a-6196-f8ac-e063-6394a90a47ab2024-09-17WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEBest Choice (Valu Merchandisers Company)5ecc500c-12d0-41dd-acb4-9190023c9ed52024-09-16WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEBest Choice (Valu Merchandisers Company)ecbf9caf-b02b-434e-8f29-50839010e8212024-09-16WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATECardinal Health (Leader) 700005f7a0905-344b-40e1-8b32-171dabb560b32024-09-10WarningsExact identifier
application number: M008
Goodsense Regular strength Stomach Relief 122BISMUTH SUBSALICYLATEGood Sense (Geiss, Destin & Dunn, Inc.)19a324bd-fa54-b899-e063-6394a90aaa732024-09-10WarningsExact identifier
application number: M008
Ultra BismuthBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0fc01a1a-4b1d-4c78-9955-220984a8019c2024-08-30WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)b22e1a0f-9866-403b-93e8-6e0e4130a75e2024-08-29WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATERugby Laboratories, Inc.87394088-1d2e-4ca4-bbfe-1481c9d4a3ba2024-08-29WarningsExact identifier
application number: M008
SootheBISMUTH SUBSALICYLATEWalgreensa2b2b0ce-034e-4857-bfca-0087bb31878e2024-07-25WarningsExact identifier
application number: M008
5-Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION07aa10e2-dd03-f32d-e063-6294a90aad0d2024-06-26WarningsExact identifier
application number: M008
Stomach ReliefSTOMACH RELIEFChain Drug Marketing Association, Inc.459abf99-63e8-43d7-a13c-9e46826984152024-06-21WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEStrategic Sourcing Services LLC2a018350-da22-4997-9181-661bb920afd32024-06-04WarningsExact identifier
application number: M008
5 Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION07a932fb-38eb-4b35-e063-6394a90ad61f2024-05-25WarningsExact 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