topcare ultra strength stomach relief

Generic: bismuth subsalicylate

Labeler: topco associates, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare ultra strength stomach relief
Generic Name bismuth subsalicylate
Labeler topco associates, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

bismuth subsalicylate 525 mg/15mL

Manufacturer
Topco Associates, LLC

Identifiers & Regulatory

Product NDC 76162-022
Product ID 76162-022_4c92ba55-f626-45cd-86a4-6a94bbe73187
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M008
Listing Expiration 2026-12-31
Marketing Start 2022-01-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162022
Hyphenated Format 76162-022

Supplemental Identifiers

RxCUI
308763
UPC
0036800993297 0036800135857
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 topcare ultra strength stomach relief (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
  • 236 mL in 1 BOTTLE (76162-022-04)
  • 354 mL in 1 BOTTLE (76162-022-05)
source: ndc

Packages (2)

76162-022-04 236 mL in 1 BOTTLE (76162-022-04) 76162-022-05 354 mL in 1 BOTTLE (76162-022-05)

Ingredients (1)

bismuth subsalicylate (525 mg/15mL)

Linked Drug Pages (1)

Topcare Ultra Strength Stomach Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c92ba55-f626-45cd-86a4-6a94bbe73187", "openfda": {"nui": ["M0002611", "N0000180183"], "upc": ["0036800993297", "0036800135857"], "unii": ["62TEY51RR1"], "rxcui": ["308763"], "spl_set_id": ["908da10c-2ed1-4917-a98b-bab63d7990d4"], "pharm_class_cs": ["Bismuth [CS]"], "pharm_class_epc": ["Bismuth [EPC]"], "manufacturer_name": ["Topco Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "236 mL in 1 BOTTLE (76162-022-04)", "package_ndc": "76162-022-04", "marketing_start_date": "20220105"}, {"sample": false, "description": "354 mL in 1 BOTTLE (76162-022-05)", "package_ndc": "76162-022-05", "marketing_start_date": "20220105"}], "brand_name": "Topcare Ultra Strength Stomach Relief", "product_id": "76162-022_4c92ba55-f626-45cd-86a4-6a94bbe73187", "dosage_form": "LIQUID", "product_ndc": "76162-022", "generic_name": "Bismuth subsalicylate", "labeler_name": "Topco Associates, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Ultra Strength Stomach Relief", "active_ingredients": [{"name": "BISMUTH SUBSALICYLATE", "strength": "525 mg/15mL"}], "application_number": "M008", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220105", "listing_expiration_date": "20261231"}