pepto-bismol ultra

Generic: bismuth subsalicylate

Labeler: procter & gamble manufactura, s. de r.l. de c.v.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pepto-bismol ultra
Generic Name bismuth subsalicylate
Labeler procter & gamble manufactura, s. de r.l. de c.v.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bismuth subsalicylate 525 mg/1

Manufacturer
Procter & Gamble Manufactura, S. de R.L. de C.V.

Identifiers & Regulatory

Product NDC 58933-478
Product ID 58933-478_40be321b-5e7e-14b6-e063-6294a90ab11f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M008
Listing Expiration 2026-12-31
Marketing Start 2018-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58933478
Hyphenated Format 58933-478

Supplemental Identifiers

RxCUI
1998447 1998449
UPC
0301490001288
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/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58933-478-12) / 12 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58933-478-24) / 24 TABLET in 1 BOTTLE
source: ndc

Packages (2)

58933-478-12 1 BOTTLE in 1 CARTON (58933-478-12) / 12 TABLET in 1 BOTTLE 58933-478-24 1 BOTTLE in 1 CARTON (58933-478-24) / 24 TABLET in 1 BOTTLE

Ingredients (1)

bismuth subsalicylate (525 mg/1)

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": "40be321b-5e7e-14b6-e063-6294a90ab11f", "openfda": {"nui": ["M0002611", "N0000180183"], "upc": ["0301490001288"], "unii": ["62TEY51RR1"], "rxcui": ["1998447", "1998449"], "spl_set_id": ["63283ebc-cff8-07d4-e053-2a91aa0a9de0"], "pharm_class_cs": ["Bismuth [CS]"], "pharm_class_epc": ["Bismuth [EPC]"], "manufacturer_name": ["Procter & Gamble Manufactura, S. de R.L. de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58933-478-12)  / 12 TABLET in 1 BOTTLE", "package_ndc": "58933-478-12", "marketing_start_date": "20180201"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58933-478-24)  / 24 TABLET in 1 BOTTLE", "package_ndc": "58933-478-24", "marketing_start_date": "20180201"}], "brand_name": "Pepto-Bismol ULTRA", "product_id": "58933-478_40be321b-5e7e-14b6-e063-6294a90ab11f", "dosage_form": "TABLET", "product_ndc": "58933-478", "generic_name": "Bismuth subsalicylate", "labeler_name": "Procter & Gamble Manufactura, S. de R.L. de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pepto-Bismol", "brand_name_suffix": "ULTRA", "active_ingredients": [{"name": "BISMUTH SUBSALICYLATE", "strength": "525 mg/1"}], "application_number": "M008", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180201", "listing_expiration_date": "20261231"}