Home NDC 0904-7205 Major Bismuth Subsalicylate
Product NDC 0904-7205
11-digit product format 009047205
Labeler code 0904
Product ID 0904-7205_61f89479-7da0-4f57-b505-d7ad3c2c52cb
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Major Pharmaceuticals
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 2026-12-31
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 2026-12-31 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 0904-7205-46 Major Bismuth Subsalicylate 5 in 1 BOX TABLET, CHEWABLE 5 4 0904-7205-46 Major Bismuth Subsalicylate 6 in 1 BLISTER PACK TABLET, CHEWABLE 6 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7205 MAJOR BISMUTH SUBSALICYLATE (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 3 Current NDC, Legacy NDC, 2 package rows 20241206_2a7c9cc1-206e-4018-b89d-7b634df43df6.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 Marketing end Sample Exclude flag Status 0904-7205-46 00904720546 5 BLISTER PACK in 1 BOX (0904-7205-46) / 6 TABLET, CHEWABLE in 1 BLISTER PACK 5 blister pack 2021-10-11 0000-00-00 No No Current