NDC 69458-713

FLANADOL PRONTO BISMUTH

Bismuth Subsalicylate

FLANADOL PRONTO BISMUTH is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Jomex International Llc. The primary component is Bismuth Subsalicylate.

Product ID69458-713_3cad412b-ffdf-4761-b750-0f1485f8a372
NDC69458-713
Product TypeHuman Otc Drug
Proprietary NameFLANADOL PRONTO BISMUTH
Generic NameBismuth Subsalicylate
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2016-04-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart335
Labeler NameJomex International Llc
Substance NameBISMUTH SUBSALICYLATE
Active Ingredient Strength262 mg/15mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 69458-713-08

355 mL in 1 BOTTLE (69458-713-08)
Marketing Start Date2016-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69458-713-08 [69458071308]

FLANADOL PRONTO BISMUTH LIQUID
Marketing CategoryOTC monograph final
Application Numberpart335
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-04-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BISMUTH SUBSALICYLATE262 mg/15mL

OpenFDA Data

SPL SET ID:d0053c7f-1448-40f6-a7e7-279d2dff926a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308762
  • UPC Code
  • 0850006000012
  • NDC Crossover Matching brand name "FLANADOL PRONTO BISMUTH" or generic name "Bismuth Subsalicylate"

    NDCBrand NameGeneric Name
    69458-713FLANADOL PRONTO BISMUTHFLANADOL PRONTO BISMUTH
    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.