Home NDC 76162-001 Topcare Stomach Relief
Product NDC 76162-001
11-digit product format 761620001
Labeler code 76162
Product ID 76162-001_cfa0f68a-3278-47da-80b3-64e17d97fa35
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 2014-12-23
Substance BISMUTH SUBSALICYLATE
Active strength 262 mg/1
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 Original Strength
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 308761 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 76162-001-85 Topcare Stomach ReliefOriginal Strength 6 in 1 CARTON TABLET 6 8 76162-001-85 Topcare Stomach ReliefOriginal Strength 5 in 1 BLISTER PACK TABLET 5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-001 TOPCARE STOMACH RELIEF ORIGINAL STRENGTH (BISMUTH SUBSALICYLATE) TABLET [TOPCO ASSOCIATES, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20231018_e4b1929c-0967-44ea-8552-6549aa2a464e.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 76162-001-85 76162000185 6 BLISTER PACK in 1 CARTON (76162-001-85) / 5 TABLET in 1 BLISTER PACK 6 blister pack 2014-12-23 0000-00-00 No No Current