Pep Tum

Product NDC
53117-046
11-digit product format
531170046
Labeler code
53117
Product ID
53117-046_affef754-2097-48fc-975b-63a35c991da7
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
First Aid Direct
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-23
Substance
BISMUTH SUBSALICYLATE
Active strength
262 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
Pep Tum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308761

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53117-046-85Pep Tum1 in 1 CELLO PACKTABLET, CHEWABLE18
53117-046-85Pep Tum30 in 1 CARTONTABLET, CHEWABLE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53117-046PEP TUM (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [FIRST AID DIRECT]8Current NDC, Legacy NDC, 2 package rows20231020_bf966e9f-2f95-41cd-a6e5-b8eb521181d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSNbf966e9f-2f95-41cd-a6e5-b8eb521181d88
308761bismuth subsalicylate 262 MG Chewable TabletSCDbf966e9f-2f95-41cd-a6e5-b8eb521181d88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53117-046-855311700468530 CELLO PACK in 1 CARTON (53117-046-85) / 1 TABLET, CHEWABLE in 1 CELLO PACK30 cello pack2014-12-230000-00-00NoNoCurrent