Home NDC 55319-948 Stomach Relief Ultra
Product NDC 55319-948
11-digit product format 553190948
Labeler code 55319
Product ID 55319-948_4919c1ef-67db-4283-99dd-5307499007e4
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form LIQUID
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
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 Stomach Relief Ultra
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 55319-948-08 Stomach Relief Ultra 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 6 55319-948-12 Stomach Relief Ultra 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-948 STOMACH RELIEF ULTRA (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 5 Current NDC, 2 package rows 20240328_6298b856-90ea-4054-bda3-70f92b14611d.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 4 of 10 · 198 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 55319-948-08 55319094808 237 mL in 1 BOTTLE, PLASTIC (55319-948-08) 237 ml 2023-07-01 No No Current 55319-948-12 55319094812 355 mL in 1 BOTTLE, PLASTIC (55319-948-12) 355 ml 2023-07-01 No No Current