Home NDC 35916-0234 Bismuth subsalicylate
Product NDC 35916-0234
11-digit product format 359160234
Labeler code 35916
Product ID 35916-0234_495a7b34-57db-3f94-e063-6394a90ad088
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Softgel Healthcare Pvt Ltd
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-27
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 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 2121072 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 35916-0234-1 Bismuth subsalicylate 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 2 35916-0234-1 Bismuth subsalicylate 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35916-0234 BISMUTH SUBSALICYLATE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD] 1 Current NDC, 2 package rows 20240528_18f59606-1498-bd0c-e063-6394a90a7df2.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 35916-0234-1 35916023401 1 BLISTER PACK in 1 CARTON (35916-0234-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2024-05-27 No No Current