pepto-bismol ultra

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

bismuth subsalicylate 525 mg/15mL

Manufacturer
The Procter & Gamble Manufacturing Company

Identifiers & Regulatory

Product NDC 37000-440
Product ID 37000-440_4081616c-9761-b040-e063-6294a90a4705
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 37000440
Hyphenated Format 37000-440

Supplemental Identifiers

RxCUI
211915 308763
UPC
0301490039281
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 ultra (source: ndc)
Generic Name bismuth subsalicylate (source: ndc)
Application Number M008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 525 mg/15mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (37000-440-04)
  • 236 mL in 1 BOTTLE, PLASTIC (37000-440-08)
  • 354 mL in 1 BOTTLE, PLASTIC (37000-440-12)
  • 3 BOTTLE, PLASTIC in 1 CELLO PACK (37000-440-36) / 354 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (4)

37000-440-04 118 mL in 1 BOTTLE, PLASTIC (37000-440-04) 37000-440-08 236 mL in 1 BOTTLE, PLASTIC (37000-440-08) 37000-440-12 354 mL in 1 BOTTLE, PLASTIC (37000-440-12) 37000-440-36 3 BOTTLE, PLASTIC in 1 CELLO PACK (37000-440-36) / 354 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

bismuth subsalicylate (525 mg/15mL)

Linked Drug Pages (1)

Pepto-Bismol Ultra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4081616c-9761-b040-e063-6294a90a4705", "openfda": {"nui": ["M0002611", "N0000180183"], "upc": ["0301490039281"], "unii": ["62TEY51RR1"], "rxcui": ["211915", "308763"], "spl_set_id": ["673893bd-f8e9-23b0-e053-2a91aa0aa1d4"], "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 (37000-440-04)", "package_ndc": "37000-440-04", "marketing_start_date": "20180301"}, {"sample": false, "description": "236 mL in 1 BOTTLE, PLASTIC (37000-440-08)", "package_ndc": "37000-440-08", "marketing_start_date": "20180301"}, {"sample": false, "description": "354 mL in 1 BOTTLE, PLASTIC (37000-440-12)", "package_ndc": "37000-440-12", "marketing_start_date": "20180301"}, {"sample": false, "description": "3 BOTTLE, PLASTIC in 1 CELLO PACK (37000-440-36)  / 354 mL in 1 BOTTLE, PLASTIC", "package_ndc": "37000-440-36", "marketing_start_date": "20240701"}], "brand_name": "Pepto-Bismol Ultra", "product_id": "37000-440_4081616c-9761-b040-e063-6294a90a4705", "dosage_form": "SUSPENSION", "product_ndc": "37000-440", "generic_name": "Bismuth subsalicylate", "labeler_name": "The Procter & Gamble Manufacturing Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pepto-Bismol", "brand_name_suffix": "Ultra", "active_ingredients": [{"name": "BISMUTH SUBSALICYLATE", "strength": "525 mg/15mL"}], "application_number": "M008", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180301", "listing_expiration_date": "20261231"}