Home NDC 53942-558 Stomach Relief
Product NDC 53942-558
11-digit product format 539420558
Labeler code 53942
Product ID 53942-558_9c832971-fd38-4183-acd5-d520aae9c8f6
Type HUMAN OTC DRUG
Nonproprietary name BISMUTH SUBSALICYLATE
Dosage form SUSPENSION
Route ORAL
Labeler Demoulas Super Markets Inc
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-10-01
Substance BISMUTH SUBSALICYLATE
Active strength 1050 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 Stomach Relief
Brand name suffix Maximum Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 1050 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 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 53942-558-26 Stomach ReliefMaximum Strength 237 mL in 1 BOTTLE SUSPENSION 237 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53942-558 STOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) SUSPENSION [DEMOULAS SUPER MARKETS INC] 2 Current NDC, Legacy NDC, 1 package rows 20231230_b2d55045-d4a4-4167-a20c-42932f35bab2.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 53942-558-26 53942055826 237 mL in 1 BOTTLE (53942-558-26) 237 ml 2018-10-01 0000-00-00 No No Current