topcare regular strength

Generic: bismuth subsalicylate

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

Drug Facts

Product Profile

Brand Name topcare regular strength
Generic Name bismuth subsalicylate
Labeler topco associates llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

bismuth subsalicylate 525 mg/30mL

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 36800-661
Product ID 36800-661_433b7a06-ddb7-da11-e063-6294a90a65ae
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M008
Listing Expiration 2026-12-31
Marketing Start 2019-05-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800661
Hyphenated Format 36800-661

Supplemental Identifiers

RxCUI
308762
UPC
0036800133174 0036800133167
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 regular strength (source: ndc)
Generic Name bismuth subsalicylate (source: ndc)
Application Number M008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 525 mg/30mL
source: ndc
Packaging
  • 236 mL in 1 BOTTLE (36800-661-08)
  • 473 mL in 1 BOTTLE (36800-661-16)
source: ndc

Packages (2)

36800-661-08 236 mL in 1 BOTTLE (36800-661-08) 36800-661-16 473 mL in 1 BOTTLE (36800-661-16)

Ingredients (1)

bismuth subsalicylate (525 mg/30mL)

Linked Drug Pages (1)

TopCare Regular Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "433b7a06-ddb7-da11-e063-6294a90a65ae", "openfda": {"nui": ["M0002611", "N0000180183"], "upc": ["0036800133174", "0036800133167"], "unii": ["62TEY51RR1"], "rxcui": ["308762"], "spl_set_id": ["2619720a-d926-4b17-899c-54d49c78802c"], "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 (36800-661-08)", "package_ndc": "36800-661-08", "marketing_start_date": "20190507"}, {"sample": false, "description": "473 mL in 1 BOTTLE (36800-661-16)", "package_ndc": "36800-661-16", "marketing_start_date": "20190507"}], "brand_name": "TopCare Regular Strength", "product_id": "36800-661_433b7a06-ddb7-da11-e063-6294a90a65ae", "dosage_form": "SUSPENSION", "pharm_class": ["Bismuth [CS]", "Bismuth [EPC]"], "product_ndc": "36800-661", "generic_name": "Bismuth subsalicylate", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare", "brand_name_suffix": "Regular Strength", "active_ingredients": [{"name": "BISMUTH SUBSALICYLATE", "strength": "525 mg/30mL"}], "application_number": "M008", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190507", "listing_expiration_date": "20261231"}