FDA.reportPublic FDA data

Pepto Bismol

Product NDC
37000-537
11-digit product format
370000537
Labeler code
37000
Product ID
37000-537_0b3cb53e-1d79-f343-e063-6394a90a17ca
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
CAPSULE, LIQUID FILLED
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
262 mg/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pepto Bismol
Brand name suffix
Diarrhea Liquicaps

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui2121072, 2121074

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-537-122021-02-12C16284748780-1ba0f9c33-1bb6-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea LiquiCaps
37000-537-242021-02-12C16284748780-1ba0f9c33-1bb6-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea LiquiCaps
37000-537-482021-02-12C16284748780-1ba0f9c33-1bb6-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea LiquiCaps
37000-537-122021-01-29C16284748780-1ba0f9c33-1bb6-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea LiquiCaps
37000-537-242021-01-29C16284748780-1ba0f9c33-1bb6-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea LiquiCaps
37000-537-482021-01-29C16284748780-1ba0f9c33-1bb6-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea LiquiCaps

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-537-12Pepto BismolDiarrhea Liquicaps1 in 1 CARTONCAPSULE, LIQUID FILLED110
37000-537-12Pepto BismolDiarrhea Liquicaps12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
37000-537-24Pepto BismolDiarrhea Liquicaps12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
37000-537-24Pepto BismolDiarrhea Liquicaps2 in 1 CARTONCAPSULE, LIQUID FILLED210
37000-537-48Pepto BismolDiarrhea Liquicaps12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
37000-537-48Pepto BismolDiarrhea Liquicaps4 in 1 CARTONCAPSULE, LIQUID FILLED410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-537PEPTO BISMOL DIARRHEA LIQUICAPS (BISMUTH SUBSALICYLATE) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Current NDC, Legacy NDC, 6 package rows20231129_851997d7-cb82-17bf-e053-2a91aa0ab78b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121072bismuth subsalicylate 262 MG Oral CapsulePSN851997d7-cb82-17bf-e053-2a91aa0ab78b10
2121074Pepto-Bismol 262 MG Oral CapsulePSN851997d7-cb82-17bf-e053-2a91aa0ab78b10
2121074bismuth subsalicylate 262 MG Oral Capsule [Pepto-bismol]SBD851997d7-cb82-17bf-e053-2a91aa0ab78b10
2121072bismuth subsalicylate 262 MG Oral CapsuleSCD851997d7-cb82-17bf-e053-2a91aa0ab78b10
2121074Pepto-bismol 262 MG Oral CapsuleSY851997d7-cb82-17bf-e053-2a91aa0ab78b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-537-12370000537121 BLISTER PACK in 1 CARTON (37000-537-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2019-03-012026-06-30NoNoCurrent
37000-537-24370000537242 BLISTER PACK in 1 CARTON (37000-537-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2019-03-010000-00-00NoNoCurrent
37000-537-48370000537484 BLISTER PACK in 1 CARTON (37000-537-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2019-03-012026-06-30NoNoCurrent