Home NDC 76162-022 Topcare Ultra Strength Stomach Relief
Product NDC 76162-022
11-digit product format 761620022
Labeler code 76162
Product ID 76162-022_4c92ba55-f626-45cd-86a4-6a94bbe73187
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 2022-01-05
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/15mL
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 Ultra Strength Stomach Relief
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 76162-022-04 Topcare Ultra Strength Stomach Relief 236 mL in 1 BOTTLE LIQUID 236 3 76162-022-05 Topcare Ultra Strength Stomach Relief 354 mL in 1 BOTTLE LIQUID 354 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-022 TOPCARE ULTRA STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [TOPCO ASSOCIATES, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241211_908da10c-2ed1-4917-a98b-bab63d7990d4.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 4 of 10 · 198 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 76162-022-04 76162002204 236 mL in 1 BOTTLE (76162-022-04) 236 ml 2022-01-05 0000-00-00 No No Current 76162-022-05 76162002205 354 mL in 1 BOTTLE (76162-022-05) 354 ml 2022-01-05 0000-00-00 No No Current