Home NDC 76281-538 Stomach Relief - Maximum Strength
Product NDC 76281-538
11-digit product format 762810538
Labeler code 76281
Product ID 76281-538_e1c9aa00-c943-4589-8f0b-92ec76d91897
Type HUMAN OTC DRUG
Nonproprietary name BISMUTH SUBSALICYLATE
Dosage form LIQUID
Route ORAL
Labeler AptaPharma 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 - 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 76281-538-26 Stomach Relief - Maximum Strength 237 mL in 1 BOTTLE LIQUID 237 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76281-538 STOMACH RELIEF - MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [APTAPHARMA INC.] 3 Current NDC, Legacy NDC, 1 package rows 20231231_15cd9163-16d6-4332-9e26-77c05e0a26a7.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 Units Marketing start Marketing end Sample Exclude flag Status 76281-538-26 76281053826 237 mL in 1 BOTTLE (76281-538-26) 237 ml 2018-10-01 0000-00-00 No No Current