FDA.reportPublic FDA data

Pepto-Bismol

Product NDC
37000-439
11-digit product format
370000439
Labeler code
37000
Product ID
37000-439_5d1b404a-9d86-a4cf-e063-6294a90a416a
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
SUSPENSION
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-03-01
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
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
Cherry
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-439-08Pepto-BismolCherry236 mL in 1 BOTTLE, PLASTICSUSPENSION23614
37000-439-12Pepto-BismolCherry354 mL in 1 BOTTLE, PLASTICSUSPENSION35414
37000-439-16Pepto-BismolCherry473 mL in 1 BOTTLE, PLASTICSUSPENSION47314
37000-439-32Pepto-BismolCherry473 mL in 1 BOTTLE, PLASTICSUSPENSION47314
37000-439-32Pepto-BismolCherry2 in 1 CARTONSUSPENSION214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-439PEPTO-BISMOL CHERRY (BISMUTH SUBSALICYLATE) SUSPENSION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Current NDC, Legacy NDC, 5 package rows20241012_67382f40-edbd-2be6-e053-2a91aa0a6700.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 9 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Soothe Ultra StrengthBISMUTH SUBSALICYLATEWalgreensec96e6f2-b087-457e-9b95-30f3595deebb2024-05-21WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATESafeway, Inc.2bde4e41-ffbd-4d9d-ae00-e39a5c7264b32024-05-15WarningsExact identifier
application number: M008
Ultra Stomach ReliefBISMUTH SUBSALICYLATESafeway, Inc.71ca1c0e-50dc-4970-ae0d-5f7be1eec6df2024-05-15WarningsExact identifier
application number: M008
PEPT-ACHEBISMUTH SUBSALICYLATEJHK Inc dba American Safety & First Aid894c1912-cd24-4ddf-b7e7-dae9dd64b2802024-04-24WarningsExact identifier
application number: M008
Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATEP & L Development, LLCcb5ca7ab-39cf-4b07-ac22-a00b214db1022024-04-16WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN67382f40-edbd-2be6-e053-2a91aa0a670014
211176Pepto-Bismol 525 MG in 30 mL Oral SuspensionPSN67382f40-edbd-2be6-e053-2a91aa0a670014
211176bismuth subsalicylate 17.5 MG/ML Oral Suspension [Pepto-bismol]SBD67382f40-edbd-2be6-e053-2a91aa0a670014
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD67382f40-edbd-2be6-e053-2a91aa0a670014
308762bismuth subsalicylate 1.75 % Oral SuspensionSY67382f40-edbd-2be6-e053-2a91aa0a670014
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY67382f40-edbd-2be6-e053-2a91aa0a670014
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY67382f40-edbd-2be6-e053-2a91aa0a670014
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY67382f40-edbd-2be6-e053-2a91aa0a670014
211176Pepto-bismol 17.5 MG/ML Oral SuspensionSY67382f40-edbd-2be6-e053-2a91aa0a670014
211176Pepto-bismol 262 MG per 15 ML Oral SuspensionSY67382f40-edbd-2be6-e053-2a91aa0a670014
211176Pepto-bismol 525 MG per 30 ML Oral SuspensionSY67382f40-edbd-2be6-e053-2a91aa0a670014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-439-0837000043908236 mL in 1 BOTTLE, PLASTIC (37000-439-08) 236 ml2018-03-010000-00-00NoNoCurrent
37000-439-1237000043912354 mL in 1 BOTTLE, PLASTIC (37000-439-12) 354 ml2018-03-010000-00-00NoNoCurrent
37000-439-1637000043916473 mL in 1 BOTTLE, PLASTIC (37000-439-16) 473 ml2018-03-010000-00-00NoNoCurrent
37000-439-32370000439322 BOTTLE, PLASTIC in 1 CARTON (37000-439-32) / 473 mL in 1 BOTTLE, PLASTIC2025-11-26NoNoCurrent