Home NDC 0536-1287 Stomach Relief
Product NDC 0536-1287
11-digit product format 005361287
Labeler code 0536
Product ID 0536-1287_97eae925-c64a-4ef6-bc32-eaa88b1a64d3
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form LIQUID
Route ORAL
Labeler Rugby Laboratories, Inc.
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-03-29
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/15mL
Pharmacologic classes Bismuth [CS], Bismuth [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Ultra
Listing expiration 2027-12-31 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 0536-1287-36 Stomach ReliefUltra 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-1287 STOMACH RELIEF ULTRA (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20240830_87394088-1d2e-4ca4-bbfe-1481c9d4a3ba.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 0536-1287-36 00536128736 237 mL in 1 BOTTLE, PLASTIC (0536-1287-36) 237 ml 2020-03-29 0000-00-00 No No Current