pepto-bismol

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-bismol
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 37000-438
Product ID 37000-438_40812d9f-d267-e0e8-e063-6394a90a827e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M008
Listing Expiration 2026-12-31
Marketing Start 2018-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37000438
Hyphenated Format 37000-438

Supplemental Identifiers

RxCUI
211176 308762
UPC
0301490039427
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-bismol (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 (37000-438-04)
  • 236 mL in 1 BOTTLE, PLASTIC (37000-438-08)
  • 354 mL in 1 BOTTLE, PLASTIC (37000-438-12)
  • 473 mL in 1 BOTTLE, PLASTIC (37000-438-16)
  • 2 BOTTLE, PLASTIC in 1 CELLO PACK (37000-438-24) / 354 mL in 1 BOTTLE, PLASTIC
  • 2 BOTTLE, PLASTIC in 1 CELLO PACK (37000-438-32) / 473 mL in 1 BOTTLE, PLASTIC
  • 100 mL in 1 BOTTLE, PLASTIC (37000-438-34)
source: ndc

Packages (7)

37000-438-04 118 mL in 1 BOTTLE, PLASTIC (37000-438-04) 37000-438-08 236 mL in 1 BOTTLE, PLASTIC (37000-438-08) 37000-438-12 354 mL in 1 BOTTLE, PLASTIC (37000-438-12) 37000-438-16 473 mL in 1 BOTTLE, PLASTIC (37000-438-16) 37000-438-24 2 BOTTLE, PLASTIC in 1 CELLO PACK (37000-438-24) / 354 mL in 1 BOTTLE, PLASTIC 37000-438-32 2 BOTTLE, PLASTIC in 1 CELLO PACK (37000-438-32) / 473 mL in 1 BOTTLE, PLASTIC 37000-438-34 100 mL in 1 BOTTLE, PLASTIC (37000-438-34)

Ingredients (1)

bismuth subsalicylate (525 mg/30mL)

Linked Drug Pages (1)

Pepto-Bismol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40812d9f-d267-e0e8-e063-6394a90a827e", "openfda": {"nui": ["M0002611", "N0000180183"], "upc": ["0301490039427"], "unii": ["62TEY51RR1"], "rxcui": ["211176", "308762"], "spl_set_id": ["67006e82-870d-8d63-e053-2991aa0a02d1"], "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 (37000-438-04)", "package_ndc": "37000-438-04", "marketing_start_date": "20180301"}, {"sample": false, "description": "236 mL in 1 BOTTLE, PLASTIC (37000-438-08)", "package_ndc": "37000-438-08", "marketing_start_date": "20180301"}, {"sample": false, "description": "354 mL in 1 BOTTLE, PLASTIC (37000-438-12)", "package_ndc": "37000-438-12", "marketing_start_date": "20180301"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (37000-438-16)", "package_ndc": "37000-438-16", "marketing_start_date": "20180301"}, {"sample": false, "description": "2 BOTTLE, PLASTIC in 1 CELLO PACK (37000-438-24)  / 354 mL in 1 BOTTLE, PLASTIC", "package_ndc": "37000-438-24", "marketing_start_date": "20180301"}, {"sample": false, "description": "2 BOTTLE, PLASTIC in 1 CELLO PACK (37000-438-32)  / 473 mL in 1 BOTTLE, PLASTIC", "package_ndc": "37000-438-32", "marketing_start_date": "20240611"}, {"sample": false, "description": "100 mL in 1 BOTTLE, PLASTIC (37000-438-34)", "package_ndc": "37000-438-34", "marketing_start_date": "20180301"}], "brand_name": "Pepto-Bismol", "product_id": "37000-438_40812d9f-d267-e0e8-e063-6394a90a827e", "dosage_form": "SUSPENSION", "product_ndc": "37000-438", "generic_name": "Bismuth subsalicylate", "labeler_name": "The Procter & Gamble Manufacturing Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pepto-Bismol", "active_ingredients": [{"name": "BISMUTH SUBSALICYLATE", "strength": "525 mg/30mL"}], "application_number": "M008", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180301", "listing_expiration_date": "20261231"}