FDA.reportPublic FDA data

UDSx Medicated System

Product NDC
83315-100
Requested package NDC
83315-100-01
11-digit product format
833150100
Labeler code
83315
Product ID
83315-100_983158f1-e2fc-492e-98f9-42a9521dc54b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide, Benzalkonium Chloride
Dosage form
KIT
Labeler
Wellbeing Medical Supply
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-03-07
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage83315-10083315-100-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…

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
UDSx Medicated System
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310429Internal RxNorm lookup
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f1df75b-101a-45da-924a-2767c34a4efeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d80d3aff-3a63-4d7b-a2be-fd9388b04330Product name920250806
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9061e89f-9c86-4196-b34b-886fc1673cc4Product name120140821

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83315-100-01UDSx Medicated System1 in 1 BOXKIT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83315-100-01EA - Each83315-100fca662df-006b-4a17-a5ff-468b4149794d12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83315-100UDSX MEDICATED SYSTEM (FUROSEMIDE, BENZALKONIUM CHLORIDE) KIT [WELLBEING MEDICAL SUPPLY]3Current NDC, 1 package rows20250410_8f1df75b-101a-45da-924a-2767c34a4efe.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UDSx Medicated SystemFUROSEMIDE, BENZALKONIUM CHLORIDEWellbeing Medical Supply8f1df75b-101a-45da-924a-2767c34a4efe2025-06-12Warnings, Adverse reactionsExact identifier
ndc (package): 83315-100-01
ndc (product): 83315-100
ndc11 (package): 83315010001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN8f1df75b-101a-45da-924a-2767c34a4efe4
310429furosemide 20 MG Oral TabletPSN8f1df75b-101a-45da-924a-2767c34a4efe4
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD8f1df75b-101a-45da-924a-2767c34a4efe4
310429furosemide 20 MG Oral TabletSCD8f1df75b-101a-45da-924a-2767c34a4efe4
1038558benzalkonium chloride 0.13 % Topical ClothSY8f1df75b-101a-45da-924a-2767c34a4efe4
1038558benzalkonium chloride 0.13 % Topical SwabSY8f1df75b-101a-45da-924a-2767c34a4efe4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY8f1df75b-101a-45da-924a-2767c34a4efe4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY8f1df75b-101a-45da-924a-2767c34a4efe4
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY8f1df75b-101a-45da-924a-2767c34a4efe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83315-100-01833150100011 KIT in 1 BOX (83315-100-01) * 1 TABLET in 1 BLISTER PACK * 1.5 mL in 1 PACKET1 kit2023-03-07NoNoCurrent