major bismuth subsalicylate

Generic: bismuth subsalicylate

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name major bismuth subsalicylate
Generic Name bismuth subsalicylate
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

bismuth subsalicylate 262 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8239
Product ID 68788-8239_522d86cb-c655-43c1-b704-0c12a9a220d7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M008
Listing Expiration 2026-12-31
Marketing Start 2021-10-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888239
Hyphenated Format 68788-8239

Supplemental Identifiers

RxCUI
308761
UNII
62TEY51RR1
NUI
M0002611 N0000180183

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 major bismuth subsalicylate (source: ndc)
Generic Name bismuth subsalicylate (source: ndc)
Application Number M008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 262 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 BOX (68788-8239-3) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
source: ndc

Packages (1)

68788-8239-3 5 BLISTER PACK in 1 BOX (68788-8239-3) / 6 TABLET, CHEWABLE in 1 BLISTER PACK

Ingredients (1)

bismuth subsalicylate (262 mg/1)

Linked Drug Pages (1)

Major Bismuth Subsalicylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "522d86cb-c655-43c1-b704-0c12a9a220d7", "openfda": {"nui": ["M0002611", "N0000180183"], "unii": ["62TEY51RR1"], "rxcui": ["308761"], "spl_set_id": ["69b9999f-c2e5-43a6-891f-0e24d3c343a4"], "pharm_class_cs": ["Bismuth [CS]"], "pharm_class_epc": ["Bismuth [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 BOX (68788-8239-3)  / 6 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "68788-8239-3", "marketing_start_date": "20250207"}], "brand_name": "Major Bismuth Subsalicylate", "product_id": "68788-8239_522d86cb-c655-43c1-b704-0c12a9a220d7", "dosage_form": "TABLET, CHEWABLE", "product_ndc": "68788-8239", "generic_name": "Bismuth subsalicylate", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Major Bismuth Subsalicylate", "active_ingredients": [{"name": "BISMUTH SUBSALICYLATE", "strength": "262 mg/1"}], "application_number": "M008", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20211011", "listing_expiration_date": "20261231"}