kaopectate

Generic: bismuth subsalicylate

Labeler: kramer laboratories
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name kaopectate
Generic Name bismuth subsalicylate
Labeler kramer laboratories
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

bismuth subsalicylate 262 mg/1

Manufacturer
Kramer Laboratories

Identifiers & Regulatory

Product NDC 55505-197
Product ID 55505-197_f7a05df8-5a3c-42b6-9d9d-417600e73afb
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M008
Listing Expiration 2026-12-31
Marketing Start 2020-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55505197
Hyphenated Format 55505-197

Supplemental Identifiers

RxCUI
308760 642349
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 kaopectate (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 BOTTLE in 1 CARTON (55505-197-07) / 28 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55505-197-70) / 42 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55505-197-77) / 84 TABLET, COATED in 1 BOTTLE
  • 2 CARTON in 1 PACKAGE (55505-197-78) / 1 BOTTLE in 1 CARTON / 42 TABLET, COATED in 1 BOTTLE
source: ndc

Packages (4)

55505-197-07 1 BOTTLE in 1 CARTON (55505-197-07) / 28 TABLET, COATED in 1 BOTTLE 55505-197-70 1 BOTTLE in 1 CARTON (55505-197-70) / 42 TABLET, COATED in 1 BOTTLE 55505-197-77 1 BOTTLE in 1 CARTON (55505-197-77) / 84 TABLET, COATED in 1 BOTTLE 55505-197-78 2 CARTON in 1 PACKAGE (55505-197-78) / 1 BOTTLE in 1 CARTON / 42 TABLET, COATED in 1 BOTTLE

Ingredients (1)

bismuth subsalicylate (262 mg/1)

Linked Drug Pages (1)

Kaopectate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f7a05df8-5a3c-42b6-9d9d-417600e73afb", "openfda": {"nui": ["M0002611", "N0000180183"], "unii": ["62TEY51RR1"], "rxcui": ["308760", "642349"], "spl_set_id": ["3877a88d-9546-48ce-ad6b-3c2a115e3eaf"], "pharm_class_cs": ["Bismuth [CS]"], "pharm_class_epc": ["Bismuth [EPC]"], "manufacturer_name": ["Kramer Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55505-197-07)  / 28 TABLET, COATED in 1 BOTTLE", "package_ndc": "55505-197-07", "marketing_start_date": "20201001"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55505-197-70)  / 42 TABLET, COATED in 1 BOTTLE", "package_ndc": "55505-197-70", "marketing_start_date": "20210201"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55505-197-77)  / 84 TABLET, COATED in 1 BOTTLE", "package_ndc": "55505-197-77", "marketing_start_date": "20251115"}, {"sample": false, "description": "2 CARTON in 1 PACKAGE (55505-197-78)  / 1 BOTTLE in 1 CARTON / 42 TABLET, COATED in 1 BOTTLE", "package_ndc": "55505-197-78", "marketing_start_date": "20250423"}], "brand_name": "Kaopectate", "product_id": "55505-197_f7a05df8-5a3c-42b6-9d9d-417600e73afb", "dosage_form": "TABLET, COATED", "pharm_class": ["Bismuth [CS]", "Bismuth [EPC]"], "product_ndc": "55505-197", "generic_name": "Bismuth subsalicylate", "labeler_name": "Kramer Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Kaopectate", "active_ingredients": [{"name": "BISMUTH SUBSALICYLATE", "strength": "262 mg/1"}], "application_number": "M008", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20201001", "listing_expiration_date": "20261231"}