Pepto

Product NDC
37000-538
11-digit product format
370000538
Labeler code
37000
Product ID
37000-538_0b38c13a-bc61-c3ab-e063-6394a90a0b5d
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
Marketing end
2026-06-30
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pepto
Brand name suffix
Diarrhea

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1

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]10Current NDC, Legacy NDC, 1 package rows20231129_8517edac-fda7-7a49-e053-2a91aa0a24cd.zip

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 ml2019-03-012026-06-30NoNoCurrent