Home NDC 36800-104 Topco Stomach Relief
Product NDC 36800-104
11-digit product format 368000104
Labeler code 36800
Product ID 36800-104_b1cb24b0-ba9b-497e-882e-951f6c1128e7
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form TABLET
Route ORAL
Labeler Topco Associates, LLC
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-10-01
Substance BISMUTH SUBSALICYLATE
Active strength 262 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Topco Stomach Relief
Listing expiration 2026-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 262 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 62TEY51RR1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308760 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-104-28 Topco Stomach Relief 40 in 1 BOTTLE TABLET 40 3 36800-104-28 Topco Stomach Relief 1 in 1 CARTON TABLET 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-104 TOPCO STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET [TOPCO ASSOCIATES, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241228_7a5be682-f13b-41a4-bf8c-724bffab2e92.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 12 · 228 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-104-28 36800010428 1 BOTTLE in 1 CARTON (36800-104-28) / 40 TABLET in 1 BOTTLE 1 bottle 2020-10-01 0000-00-00 No No Current