Home NDC 53041-529 Ultra Strength Stomach Relief
Product NDC 53041-529
11-digit product format 530410529
Labeler code 53041
Product ID 53041-529_1de872f9-cb40-4614-a064-bd865e8bcab4
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form LIQUID
Route ORAL
Labeler Guardian Drug Company
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-10
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 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 53041-529-04 Ultra Strength Stomach Relief 236 mL in 1 BOTTLE LIQUID 236 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53041-529 ULTRA STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY] 2 Current NDC, 1 package rows 20250312_25175eac-d15f-ce0d-e063-6394a90a0650.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 Sample Exclude flag Status 53041-529-04 53041052904 236 mL in 1 BOTTLE (53041-529-04) 236 ml 2025-02-10 No No Current