Home NDC 36800-769 Topcare Stomach Relief cherry
Product NDC 36800-769
11-digit product format 368000769
Labeler code 36800
Product ID 36800-769_9adba611-0414-46d8-85cb-6f07cc52dca9
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form LIQUID
Route ORAL
Labeler Topco Associates, LLC
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-12-17
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/30mL
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 cherry
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 525 mg/30mL
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 308762 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 36800-769-04 Topcare Stomach Relief cherry 236 mL in 1 BOTTLE LIQUID 236 3 36800-769-06 Topcare Stomach Relief cherry 473 mL in 1 BOTTLE LIQUID 473 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-769 TOPCARE STOMACH RELIEF CHERRY (BISMUTH SUBSALICYLATE) LIQUID [TOPCO ASSOCIATES, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241228_154b4b8f-c4d6-414b-aac3-88475669e19d.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 36800-769-04 36800076904 236 mL in 1 BOTTLE (36800-769-04) 236 ml 2021-12-17 0000-00-00 No No Current 36800-769-06 36800076906 473 mL in 1 BOTTLE (36800-769-06) 473 ml 2021-12-17 0000-00-00 No No Current