Home NDC 36800-341 TopCare Stomach Relief
Product NDC 36800-341
11-digit product format 368000341
Labeler code 36800
Product ID 36800-341_433b9bca-9b39-cacb-e063-6294a90a7523
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form SUSPENSION
Route ORAL
Labeler TOPCO ASSOCIATES LLC
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-14
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/15mL
Pharmacologic classes Bismuth [CS], Bismuth [EPC]
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 TopCare Stomach Relief
Brand name suffix Ultra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 525 mg/15mL
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 308763 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 36800-341-08 TopCare Stomach ReliefUltra Strength 236 mL in 1 BOTTLE SUSPENSION 236 7 36800-341-12 TopCare Stomach ReliefUltra Strength 354 mL in 1 BOTTLE SUSPENSION 354 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-341 TOPCARE STOMACH RELIEF ULTRA STRENGTH (BISMUTH SUBSALICYLATE) SUSPENSION [TOPCO ASSOCIATES LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241107_e745e693-9e45-43b0-b26c-99ca891b74b0.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 · 223 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 36800-341-08 36800034108 236 mL in 1 BOTTLE (36800-341-08) 236 ml 2019-03-14 0000-00-00 No No Current 36800-341-12 36800034112 354 mL in 1 BOTTLE (36800-341-12) 354 ml 2019-03-14 0000-00-00 No No Current