Home NDC 81033-046 Bismuth Subsalicylate
Product NDC 81033-046
11-digit product format 810330046
Labeler code 81033
Product ID 81033-046_5b126fca-aaea-4d57-e063-6394a90aafb5
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form LIQUID
Route ORAL
Labeler Kesin Pharma
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-03
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/30mL
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 Bismuth Subsalicylate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 525 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 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 5 of 10 · 186 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 81033-046-34 81033004634 30 CUP, UNIT-DOSE in 1 CARTON (81033-046-34) / 15 mL in 1 CUP, UNIT-DOSE (81033-046-15) 2026-09-09 No No Current