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 69423-966
Product ID 69423-966_47f5d3d6-3794-6bb2-e063-6294a90a42e6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M008
Listing Expiration 2027-12-31
Marketing Start 2022-03-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69423966
Hyphenated Format 69423-966

Supplemental Identifiers

RxCUI
211915 308763
UPC
0301490002124
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
  • 354 mL in 1 BOTTLE, PLASTIC (69423-966-12)
source: ndc

Packages (1)

69423-966-12 354 mL in 1 BOTTLE, PLASTIC (69423-966-12)

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": "47f5d3d6-3794-6bb2-e063-6294a90a42e6", "openfda": {"nui": ["M0002611", "N0000180183"], "upc": ["0301490002124"], "unii": ["62TEY51RR1"], "rxcui": ["211915", "308763"], "spl_set_id": ["d800eb8c-42c8-fb12-e053-2a95a90af2a2"], "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": "354 mL in 1 BOTTLE, PLASTIC (69423-966-12)", "package_ndc": "69423-966-12", "marketing_start_date": "20220307"}], "brand_name": "Pepto Bismol Ultra", "product_id": "69423-966_47f5d3d6-3794-6bb2-e063-6294a90a42e6", "dosage_form": "SUSPENSION", "product_ndc": "69423-966", "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": "20220307", "listing_expiration_date": "20271231"}