Home NDC 76281-557 Bismuth Subsalicylate Suspension
Product NDC 76281-557
11-digit product format 762810557
Labeler code 76281
Product ID 76281-557_ede65c2c-4034-46e5-9088-9efa801d6ec1
Type HUMAN OTC DRUG
Nonproprietary name BISMUTH SUBSALICYLATE
Dosage form SUSPENSION
Route ORAL
Labeler AptaPharma Inc.
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-01
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 Suspension
Brand name suffix Regular Strength
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308762 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76281-557-28 76281055728 354 mL in 1 BOTTLE (76281-557-28) 354 ml 2026-03-01 No No Current