NDC 37000-438

Pepto-Bismol

Bismuth Subsalicylate

Pepto-Bismol is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by The Procter & Gamble Manufacturing Company. The primary component is Bismuth Subsalicylate.

Product ID37000-438_6e73ee84-4101-0e05-e053-2991aa0a04fd
NDC37000-438
Product TypeHuman Otc Drug
Proprietary NamePepto-Bismol
Generic NameBismuth Subsalicylate
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2018-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart335
Labeler NameThe Procter & Gamble Manufacturing Company
Substance NameBISMUTH SUBSALICYLATE
Active Ingredient Strength525 mg/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 37000-438-04

118 mL in 1 BOTTLE, PLASTIC (37000-438-04)
Marketing Start Date2018-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 37000-438-08 [37000043808]

Pepto-Bismol SUSPENSION
Marketing CategoryOTC monograph final
Application Numberpart335
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 37000-438-16 [37000043816]

Pepto-Bismol SUSPENSION
Marketing CategoryOTC monograph final
Application Numberpart335
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 37000-438-24 [37000043824]

Pepto-Bismol SUSPENSION
Marketing CategoryOTC monograph final
Application Numberpart335
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 37000-438-04 [37000043804]

Pepto-Bismol SUSPENSION
Marketing CategoryOTC monograph final
Application Numberpart335
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 37000-438-34 [37000043834]

Pepto-Bismol SUSPENSION
Marketing CategoryOTC monograph final
Application Numberpart335
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 37000-438-12 [37000043812]

Pepto-Bismol SUSPENSION
Marketing CategoryOTC monograph final
Application Numberpart335
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 37000-438-32 [37000043832]

Pepto-Bismol SUSPENSION
Marketing CategoryOTC monograph final
Application Numberpart335
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

Drug Details

Active Ingredients

IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

OpenFDA Data

SPL SET ID:67006e82-870d-8d63-e053-2991aa0a02d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 211176
  • 308762
  • NDC Crossover Matching brand name "Pepto-Bismol" or generic name "Bismuth Subsalicylate"

    NDCBrand NameGeneric Name
    37000-402Pepto-BismolPepto-Bismol
    37000-403Pepto-BismolPepto-Bismol
    37000-476Pepto-BismolPepto-Bismol
    37000-477Pepto-BismolPepto-Bismol
    37000-032Pepto-BismolPepto-Bismol
    37000-018Pepto-BismolPepto-Bismol
    37000-438Pepto-BismolPepto-Bismol
    37000-475Pepto-BismolPepto-Bismol
    50090-0553Pepto-BismolPepto-Bismol
    50269-691Pepto-BismolPepto-Bismol
    58933-477Pepto-BismolPepto-Bismol
    58933-018Pepto-BismolPepto-Bismol
    58933-476Pepto-BismolPepto-Bismol
    66715-9723Pepto-BismolPepto-Bismol
    73097-010Pepto-BismolPepto-Bismol
    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

    Trademark Results [Pepto-Bismol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PEPTO-BISMOL
    PEPTO-BISMOL
    77587409 3737895 Dead/Cancelled
    The Procter & Gamble Company
    2008-10-07
    PEPTO-BISMOL
    PEPTO-BISMOL
    73412729 1269605 Dead/Cancelled
    Norwich Eaton Pharmaceuticals, Inc.
    1983-02-07
    PEPTO-BISMOL
    PEPTO-BISMOL
    72428703 0972198 Live/Registered
    MORTON-NORWICH PRODUCTS, INC.
    1972-06-29
    PEPTO-BISMOL
    PEPTO-BISMOL
    71236388 0224933 Live/Registered
    NORWICH PHARMACAL COMPANY, THE
    1926-08-24

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