Home NDC 68788-8239 Major Bismuth Subsalicylate
Product NDC 68788-8239
11-digit product format 687888239
Labeler code 68788
Product ID 68788-8239_6ad4aa56-96a5-413c-8abd-dec8ead6bb1a
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 2021-10-11
Substance BISMUTH SUBSALICYLATE
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 Major Bismuth Subsalicylate
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-8239-3 Major Bismuth Subsalicylate 6 in 1 BLISTER PACK TABLET, CHEWABLE 6 4 68788-8239-3 Major Bismuth Subsalicylate 5 in 1 BOX TABLET, CHEWABLE 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8239 MAJOR BISMUTH SUBSALICYLATE (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS INC.] 3 Current NDC, 2 package rows 20250210_69b9999f-c2e5-43a6-891f-0e24d3c343a4.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 1 of 12 · 223 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8239-3 68788823903 5 BLISTER PACK in 1 BOX (68788-8239-3) / 6 TABLET, CHEWABLE in 1 BLISTER PACK 5 blister pack 2025-02-07 No No Current