bismuth subsalicylate

Generic: bismuth subsalicylate

Labeler: softgel healthcare pvt ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name bismuth subsalicylate
Generic Name bismuth subsalicylate
Labeler softgel healthcare pvt ltd
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

bismuth subsalicylate 262 mg/1

Manufacturer
Softgel Healthcare Pvt Ltd

Identifiers & Regulatory

Product NDC 35916-0234
Product ID 35916-0234_495a7b34-57db-3f94-e063-6394a90ad088
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M008
Listing Expiration 2027-12-31
Marketing Start 2024-05-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 359160234
Hyphenated Format 35916-0234

Supplemental Identifiers

RxCUI
2121072
UPC
0335916023417
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 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
  • 1 BLISTER PACK in 1 CARTON (35916-0234-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

35916-0234-1 1 BLISTER PACK in 1 CARTON (35916-0234-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (1)

bismuth subsalicylate (262 mg/1)

Linked Drug Pages (1)

Bismuth subsalicylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "495a7b34-57db-3f94-e063-6394a90ad088", "openfda": {"nui": ["M0002611", "N0000180183"], "upc": ["0335916023417"], "unii": ["62TEY51RR1"], "rxcui": ["2121072"], "spl_set_id": ["18f59606-1498-bd0c-e063-6394a90a7df2"], "pharm_class_cs": ["Bismuth [CS]"], "pharm_class_epc": ["Bismuth [EPC]"], "manufacturer_name": ["Softgel Healthcare Pvt Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (35916-0234-1)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "35916-0234-1", "marketing_start_date": "20240527"}], "brand_name": "Bismuth subsalicylate", "product_id": "35916-0234_495a7b34-57db-3f94-e063-6394a90ad088", "dosage_form": "CAPSULE, LIQUID FILLED", "product_ndc": "35916-0234", "generic_name": "Bismuth subsalicylate", "labeler_name": "Softgel Healthcare Pvt Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Bismuth subsalicylate", "active_ingredients": [{"name": "BISMUTH SUBSALICYLATE", "strength": "262 mg/1"}], "application_number": "M008", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240527", "listing_expiration_date": "20271231"}