Home NDC 55910-637 Ultra Bismuth
Product NDC 55910-637
11-digit product format 559100637
Labeler code 55910
Product ID 55910-637_c751324d-47d9-49f0-b941-a526747e71c3
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form LIQUID
Route ORAL
Labeler Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-29
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/15mL
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 Ultra Bismuth
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 525 mg/15mL
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 308763 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 55910-637-04 Ultra Bismuth 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 5 55910-637-12 Ultra Bismuth 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-637 ULTRA BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)] 5 Current NDC, Legacy NDC, 2 package rows 20240831_0fc01a1a-4b1d-4c78-9955-220984a8019c.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 55910-637-04 55910063704 118 mL in 1 BOTTLE, PLASTIC (55910-637-04) 118 ml 2019-11-29 0000-00-00 No No Current 55910-637-12 55910063712 355 mL in 1 BOTTLE, PLASTIC (55910-637-12) 355 ml 2019-11-29 0000-00-00 No No Current