Home NDC 83393-749-08 Treda Ultra
Product NDC 83393-749
Requested package NDC 83393-749-08
11-digit product format 833930749
Labeler code 83393
Product ID 83393-749_bf8d9411-58f5-4b37-8af1-6b7142172ef2
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form TABLET
Route ORAL
Labeler Laboratorios Sanfer, S.A. de C.V.
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-06
Substance BISMUTH SUBSALICYLATE
Active strength 525 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 Treda Ultra
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 525 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 1998447 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 83393-749-08 Treda Ultra 1 in 1 CARTON TABLET 1 3 83393-749-08 Treda Ultra 24 in 1 BOTTLE, PLASTIC TABLET 24 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83393-749 TREDA ULTRA (BISMUTH SUBSALICYLATE) TABLET [LABORATORIOS SANFER, S.A. DE C.V.] 2 Current NDC, 2 package rows 20250217_cfa7f37a-e18b-4929-b3a4-4126b0aa679a.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 Marketing start Sample Exclude flag Status 83393-749-08 83393074908 1 BOTTLE, PLASTIC in 1 CARTON (83393-749-08) / 24 TABLET in 1 BOTTLE, PLASTIC 2024-02-06 No No Current