Pepto-Bismol

Product NDC
58933-478
11-digit product format
589330478
Labeler code
58933
Product ID
58933-478_40be321b-5e7e-14b6-e063-6294a90ab11f
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
Procter & Gamble Manufactura, S. de R.L. de C.V.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-01
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pepto-Bismol
Brand name suffix
ULTRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui1998447, 1998449

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-478-12Pepto-BismolULTRA12 in 1 BOTTLETABLET1210
58933-478-12Pepto-BismolULTRA1 in 1 CARTONTABLET110
58933-478-24Pepto-BismolULTRA1 in 1 CARTONTABLET110
58933-478-24Pepto-BismolULTRA24 in 1 BOTTLETABLET2410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-478PEPTO-BISMOL ULTRA (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURA, S. DE R.L. DE C.V.]9Current NDC, Legacy NDC, 4 package rows20241012_63283ebc-cff8-07d4-e053-2a91aa0a9de0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1998447bismuth subsalicylate 525 MG Oral TabletPSN63283ebc-cff8-07d4-e053-2a91aa0a9de010
1998449Pepto-Bismol ULTRA 525 MG Oral TabletPSN63283ebc-cff8-07d4-e053-2a91aa0a9de010
1998449bismuth subsalicylate 525 MG Oral Tablet [Pepto-bismol]SBD63283ebc-cff8-07d4-e053-2a91aa0a9de010
1998447bismuth subsalicylate 525 MG Oral TabletSCD63283ebc-cff8-07d4-e053-2a91aa0a9de010
1998449Pepto-bismol 525 MG Oral TabletSY63283ebc-cff8-07d4-e053-2a91aa0a9de010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58933-478-12589330478121 BOTTLE in 1 CARTON (58933-478-12) / 12 TABLET in 1 BOTTLE1 bottle2018-02-010000-00-00NoNoCurrent
58933-478-24589330478241 BOTTLE in 1 CARTON (58933-478-24) / 24 TABLET in 1 BOTTLE1 bottle2018-02-010000-00-00NoNoCurrent