Home NDC 70000-0594 Bismuth Subsalicylate
Product NDC 70000-0594
11-digit product format 700000594
Labeler code 70000
Product ID 70000-0594_2de450b8-01e2-0e3b-e063-6394a90af5f7
Type HUMAN OTC DRUG
Nonproprietary name Bismuth Subsalicylate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler LEADER/ Cardinal Health 110, Inc.
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-03
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 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 308760 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 70000-0594-1 Bismuth Subsalicylate 24 in 1 BOTTLE TABLET, FILM COATED 24 3 70000-0594-1 Bismuth Subsalicylate 1 in 1 CARTON TABLET, FILM COATED 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0594 BISMUTH SUBSALICYLATE TABLET, FILM COATED [LEADER/ CARDINAL HEALTH 110, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20250213_d4af6694-910c-da17-e053-2995a90a8454.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 70000-0594-1 70000059401 1 BOTTLE in 1 CARTON (70000-0594-1) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2022-01-03 0000-00-00 No No Current