pepto diarrhea

Generic: bismuth subsalicylate

Labeler: the procter & gamble manufacturing company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pepto diarrhea
Generic Name bismuth subsalicylate
Labeler the procter & gamble manufacturing company
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

bismuth subsalicylate 525 mg/30mL

Manufacturer
The Procter & Gamble Manufacturing Company

Identifiers & Regulatory

Product NDC 37000-538
Product ID 37000-538_0b38c13a-bc61-c3ab-e063-6394a90a0b5d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M008
Marketing Start 2018-03-01
Marketing End 2026-06-30

Pharmacologic Class

Established (EPC)
bismuth [epc]
Chemical Structure
bismuth [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37000538
Hyphenated Format 37000-538

Supplemental Identifiers

UPC
0301490001660
UNII
62TEY51RR1
NUI
M0002611 N0000180183

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pepto diarrhea (source: ndc)
Generic Name bismuth subsalicylate (source: ndc)
Application Number M008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 525 mg/30mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (37000-538-04)
source: ndc

Packages (1)

37000-538-04 118 mL in 1 BOTTLE, PLASTIC (37000-538-04)

Ingredients (1)

bismuth subsalicylate (525 mg/30mL)

Linked Drug Pages (1)

Pepto Diarrhea ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0b38c13a-bc61-c3ab-e063-6394a90a0b5d", "openfda": {"nui": ["M0002611", "N0000180183"], "upc": ["0301490001660"], "unii": ["62TEY51RR1"], "spl_set_id": ["8517edac-fda7-7a49-e053-2a91aa0a24cd"], "pharm_class_cs": ["Bismuth [CS]"], "pharm_class_epc": ["Bismuth [EPC]"], "manufacturer_name": ["The Procter & Gamble Manufacturing Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (37000-538-04)", "package_ndc": "37000-538-04", "marketing_end_date": "20260630", "marketing_start_date": "20190301"}], "brand_name": "Pepto Diarrhea", "product_id": "37000-538_0b38c13a-bc61-c3ab-e063-6394a90a0b5d", "dosage_form": "SUSPENSION", "product_ndc": "37000-538", "generic_name": "Bismuth subsalicylate", "labeler_name": "The Procter & Gamble Manufacturing Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pepto", "brand_name_suffix": "Diarrhea", "active_ingredients": [{"name": "BISMUTH SUBSALICYLATE", "strength": "525 mg/30mL"}], "application_number": "M008", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20260630", "marketing_start_date": "20180301"}