FDA.reportPublic FDA data

Pepto

Product NDC
37000-538
11-digit product format
370000538
Labeler code
37000
Product ID
37000-538_eeb38418-92fb-4372-e053-2a95a90a67f2
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 FINAL
Marketing start
2018-03-01
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37000-538DDiscontinued by firm2026-10-15
excluded packagepackage37000-53837000-538-04DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-538-042021-02-12C16284748780-1ba0f9c33-1bb9-a910-e053-dadaa90a0b85Pepto ® Diarrhea
37000-538-042021-01-29C16284748780-1ba0f9c33-1bb9-a910-e053-dadaa90a0b85Pepto ® Diarrhea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-538-04PeptoDiarrhea118 mL in 1 BOTTLE, PLASTICSUSPENSION11810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-538PEPTO DIARRHEA (BISMUTH SUBSALICYLATE) SUSPENSION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Legacy NDC, 1 package rows20231129_8517edac-fda7-7a49-e053-2a91aa0a24cd.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 6 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECARDINAL HEALTH 110, LLC. DBA LEADER7d6047a9-5557-487a-ae06-f904dac626c92025-10-14WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEAtlantic Biologicals Corp401f8393-680c-e1a8-e063-6394a90a81ab2025-10-01WarningsExact identifier
application number: M008
First Aid Direct Peptum TabsBISMUTH SUBSALICYLATECintas Corpdd14cd57-3f7c-4634-9da9-6f83dc5bae122025-09-29WarningsExact identifier
application number: M008
RIGHT REMEDIES Stomach Relief BISMUTH SUBSALICYLATE 262 mg softgelBISMUTH SUBSALICYLATEStrive Pharmaceuticals Inc.0f271054-fa96-4475-8279-65f4565aba362025-09-22WarningsExact identifier
application number: M008
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEFSA Store Inc. (Caring Mill)fbabc313-600a-4722-9948-1a3e214140592025-09-18WarningsExact identifier
application number: M008
QUALITY CHOICE ULTRA STRENGTH STOMACH RELIEFBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)67c610b1-fe94-4ad3-ad1a-8bd93a4da9d92025-09-11WarningsExact identifier
application number: M008
Medique DiotameBISMUTH SUBSALICYLATEUnifirst First Aid Corporation0667ec26-c2cd-153c-e054-00144ff88e882025-09-08WarningsExact identifier
application number: M008
McKesson BismuthBISMUTH SUBSALICYLATEMcKesson Medical-Surgicald1f3dfa4-e021-6384-e053-2995a90a7b422025-09-08WarningsExact identifier
application number: M008
Medi-First Pep-T-MedBISMUTH SUBSALICYLATEUnifirst First Aid Corporation88f4d5d4-92ed-40ab-97a9-181da72f869b2025-09-08WarningsExact identifier
application number: M008
Thompson Chewable Bismuth TabsBISMUTH SUBSALICYLATEThompson Safety LLCc94b9bc2-b764-a9a7-e053-2a95a90aed812025-09-08WarningsExact identifier
application number: M008
Goodsense Regular strength Stomach Relief 122BISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.f0588ab8-d1fc-419a-8d68-bee42332d50f2025-08-01WarningsExact identifier
application number: M008
Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATE 525 MGRetail Business Services, LLC.338ca589-91ff-30ed-e063-6294a90a243a2025-07-21WarningsExact identifier
application number: M008
Regular Strength Stomach ReliefBISMUTH SUBSALICYLATE 525 MGRetail Business Services, LLC.338d61af-35a8-fba7-e063-6294a90a38e82025-07-21WarningsExact identifier
application number: M008
SennaSENNOSIDESMajor Pharmaceuticalscfb6bf89-c77e-4372-9bc9-44d6a659c9552025-07-18WarningsExact identifier
application number: M008
Major Bismuth SubsalicylateBISMUTH SUBSALICYLATEMajor Pharmaceuticals2a7c9cc1-206e-4018-b89d-7b634df43df62025-07-11WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55440401-f82f-45a3-ba7e-6ccdfdacead32025-07-10WarningsExact identifier
application number: M008
Upset Stomach Relief-Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATE 262 MGPioneer Life Sciences, LLC07e2cc82-ab0e-46c5-863b-67658b6126782025-06-27WarningsExact identifier
application number: M008
Upset Stomach Relief-Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATE 262 MGNUVICARE LLC6697e464-00ac-41de-a7ea-d7bb24ed5e2a2025-06-25WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEP & L Development, LLC8383945f-b3a7-4242-bfaa-acf24b66406d2025-05-30WarningsExact identifier
application number: M008
5-Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION28fba615-48ca-8d96-e063-6394a90a27972025-04-12WarningsExact identifier
application number: M008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-538-0437000053804118 mL in 1 BOTTLE, PLASTIC (37000-538-04) 118 ml2019-03-010000-00-00NoNoCurrent