NDC 53117-046

Pep Tum

Bismuth Subsalicylate

Pep Tum is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by First Aid Direct. The primary component is Bismuth Subsalicylate.

Product ID53117-046_d70f5729-4c48-4374-9714-5a2542e98f88
NDC53117-046
Product TypeHuman Otc Drug
Proprietary NamePep Tum
Generic NameBismuth Subsalicylate
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2014-12-23
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart335
Labeler NameFirst Aid Direct
Substance NameBISMUTH SUBSALICYLATE
Active Ingredient Strength262 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 53117-046-85

30 CELLO PACK in 1 CARTON (53117-046-85) > 1 TABLET, CHEWABLE in 1 CELLO PACK
Marketing Start Date2014-12-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53117-046-85 [53117004685]

Pep Tum TABLET, CHEWABLE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart335
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-12-23

Drug Details

Active Ingredients

IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

OpenFDA Data

SPL SET ID:bf966e9f-2f95-41cd-a6e5-b8eb521181d8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308761
  • NDC Crossover Matching brand name "Pep Tum" or generic name "Bismuth Subsalicylate"

    NDCBrand NameGeneric Name
    53117-046Pep TumPep Tum
    0113-7469basic care stomach reliefBismuth subsalicylate
    0904-1313BismatrolBismuth Subsalicylate
    0904-1314BismatrolBismuth Subsalicylate
    0536-4301Bismuth subsalicylateBismuth subsalicylate
    0113-0302Good Sense Stomach ReliefBismuth subsalicylate
    0113-0337Good Sense Stomach Reliefbismuth subsalicylate
    0113-0469good sense stomach reliefBismuth subsalicylate
    0322-2222Percy MedicineBismuth Subsalicylate
    0121-4803Pink BismuthBismuth Subsalicylate
    0536-1810PINK BISMUTHbismuth subsalicylate
    0363-0025SootheBismuth subsalicylate
    0363-0073SootheBismuth subsalicylate
    0363-0319SootheBISMUTH SUBSALICYLATE
    0363-0346SootheBismuth Subsalicylate
    0363-0371SootheBismuth subsalicylate
    0363-0736SootheBismuth subsalicylate
    0363-7240SootheBismuth subsalicylate
    0363-7370SootheBismuth subsalicylate
    0121-0910Stomach ReliefBismuth subsalicylate
    0536-1286Stomach ReliefBismuth subsalicylate
    0536-1287Stomach ReliefBismuth subsalicylate
    0363-1302Ultra Strength digestive reliefBismuth subsalicylate
    0363-9124WalgreenBismuth Subsalicylate
    0363-9125WalgreenBismuth Subsalicylate

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