Home NDC 83059-0166 Stomach Relief
Product NDC 83059-0166
11-digit product format 830590166
Labeler code 83059
Product ID 83059-0166_579b7c9e-5aa3-fbbb-e063-6294a90acaea
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Shield Pharmaceuticals Corp
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-27
Substance BISMUTH
Active strength 262 mg/1
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH 262 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U015TT5I8H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2121072 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83059-0166-8 83059016608 1 BLISTER PACK in 1 CARTON (83059-0166-8) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2026-07-27 No No Current