Home NDC 76162-406 TopCare Bismuth Stomach Relief
Product NDC 76162-406
11-digit product format 761620406
Labeler code 76162
Product ID 76162-406_308f4b2a-2300-42b9-e063-6394a90acc75
Type HUMAN OTC DRUG
Nonproprietary name Bismuth
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler TopCo
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-17
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 Bismuth 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 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 76162-406-24 TopCare Bismuth Stomach Relief 24 in 1 BOTTLE TABLET, CHEWABLE 24 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-406 TOPCARE BISMUTH STOMACH RELIEF (BISMUTH) TABLET, CHEWABLE [TOPCO] 1 Current NDC, 1 package rows 20250321_308f4b2a-22ff-42b9-e063-6394a90acc75.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 Marketing start Sample Exclude flag Status 76162-406-24 76162040624 24 TABLET, CHEWABLE in 1 BOTTLE (76162-406-24) 2025-03-17 No No Current