Home NDC 68788-4116 Bismuth Subsalicylate 262 mg
Product NDC 68788-4116
11-digit product format 687884116
Labeler code 68788
Product ID 68788-4116_f7627bf1-da97-4875-b614-5029663f7482
Type HUMAN OTC DRUG
Nonproprietary name Bismuth Subsalicylate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-08
Substance BISMUTH SUBSALICYLATE
Active strength 262 mg/1
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 Bismuth Subsalicylate 262 mg
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 262 mg/1
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 308761 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 1 of 12 · 223 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68788-4116-3 68788411603 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (68788-4116-3) 2026-06-08 No No Current