FDA.reportPublic FDA data

Pepto Bismol

Product NDC
67751-155
11-digit product format
677510155
Labeler code
67751
Product ID
67751-155_4efb4585-b90f-f303-e063-6294a90a4ba6
Type
HUMAN OTC DRUG
Nonproprietary name
BISMUTH SUBSALICYLATE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-20
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pepto Bismol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui211151, 308761

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-155-012024-04-15C16284748780-1f386c649-f669-0266-e053-dadaa90a7c1aPepto Bismol
67751-155-022024-04-15C16284748780-1f386c649-f669-0266-e053-dadaa90a7c1aPepto Bismol
67751-155-012023-01-30C16284748780-1f386c649-f669-0266-e053-dadaa90a7c1aPepto Bismol
67751-155-022023-01-30C16284748780-1f386c649-f669-0266-e053-dadaa90a7c1aPepto Bismol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-155-01Pepto Bismol1 in 1 CARTONTABLET, CHEWABLE14
67751-155-01Pepto Bismol2 in 1 POUCHTABLET, CHEWABLE24
67751-155-02Pepto Bismol1 in 1 CARTONTABLET, CHEWABLE14
67751-155-02Pepto Bismol4 in 1 POUCHTABLET, CHEWABLE44
67751-155-06Pepto Bismol2 in 1 POUCHTABLET, CHEWABLE24
67751-155-06Pepto Bismol3 in 1 CARTONTABLET, CHEWABLE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-155PEPTO BISMOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [NAVAJO MANUFACTURING COMPANY INC.]3Current NDC, Legacy NDC, 6 package rows20240417_033bccc6-6e81-487f-91fe-9d7cc465e1b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151Pepto-Bismol 262 MG Chewable TabletPSN033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBD033bccc6-6e81-487f-91fe-9d7cc465e1b24
308761bismuth subsalicylate 262 MG Chewable TabletSCD033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151Pepto-bismol 262 MG Chewable TabletSY033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSY033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151Pepto-Bismol To-Go 262 MG Chewable TabletSY033bccc6-6e81-487f-91fe-9d7cc465e1b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-155-01677510155011 POUCH in 1 CARTON (67751-155-01) / 2 TABLET, CHEWABLE in 1 POUCH1 pouch2016-09-200000-00-00NoNoCurrent
67751-155-02677510155021 POUCH in 1 CARTON (67751-155-02) / 4 TABLET, CHEWABLE in 1 POUCH1 pouch2016-09-200000-00-00NoNoCurrent
67751-155-06677510155063 POUCH in 1 CARTON (67751-155-06) / 2 TABLET, CHEWABLE in 1 POUCH3 pouch2025-04-22NoNoCurrent