FDA.reportPublic FDA data

NDC 80425-0409-01 - NALOXONE HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0409
Requested NDC
80425-0409-01
Package NDCs from labels
80425-0409-1, 80425-0409-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-06-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NALOXONE HYDROCHLORIDE - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-06-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0409-1NALOXONE HYDROCHLORIDE0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.11
80425-0409-1NALOXONE HYDROCHLORIDE2 in 1 CARTONSPRAY21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0409NALOXONE HYDROCHLORIDE SPRAY [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 2 package rows20240704_1be2e38b-55ca-abea-e063-6394a90ac548.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0409-1EA - Each80425-04099f52f7b9-3b5d-4207-b36a-6c6219b5d57112024-08-12

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 33 of 111 · 2,214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biopure Antibacterial Hand Wipe Juicy WatermelonBENZALKONIUM CHLORIDEQuest USA Corp47d53645-4ba8-0cdc-e063-6294a90a38922026-01-07WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand Wipe Berry StrawberryBENZALKONIUM CHLORIDEQuest USA Corp47d6574c-0d4c-392e-e063-6394a90a590f2026-01-07WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand Wipe Vallina DreamBENZALKONIUM CHLORIDEQuest USA Corp47d7090d-036b-870b-e063-6394a90a80c32026-01-07WarningsExact identifier
unii: F5UM2KM3W7
Sodium chlorideSODIUM CHLORIDEBECTON DICKINSON AND COMPANYd39b7307-df67-4e68-acb0-2eda5dc612152026-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltdb5d40220-f194-4835-b70c-f304ecb222d52026-01-06WarningsExact identifier
application number: ANDA211951
ndc (product): 45802-578
rxcui: 1725059
spl id: 10534467-f259-44bb-bdf7-b09de54411ed
spl set id: b5d40220-f194-4835-b70c-f304ecb222d5
unii: F850569PQR
99 Plus Hand SanitizerBENZEALKONIUM CHLORIDEMomar Incorporatedf972a8f1-c928-4e4b-a8dd-a2fb77052d212026-01-06WarningsExact identifier
unii: F5UM2KM3W7
QS Plus Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDEABC Compounding Co., Inc.343f9139-47bc-44b0-9da1-d9d6f6334bc72026-01-06WarningsExact identifier
unii: F5UM2KM3W7
Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze ScentBENZALKONIUM CHLORIDEQuest USA Corp47c105a8-7c76-9cde-e063-6294a90a92842026-01-06WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic Cleaning wipeANTISEPTIC CLEANING WIPESHENZHEN BENLIJU BIO-TECH CO.,LTD203d01ae-d99e-bce3-e063-6294a90a1a2d2026-01-05WarningsExact identifier
unii: F5UM2KM3W7
Hand wipesHAND WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD39f3acca-7275-88ca-e063-6394a90ad1a22026-01-05WarningsExact identifier
unii: F5UM2KM3W7
Wipex Sanitizing WipesBENZALKONIUM CHLORIDEUnico476d7085-82d8-5e84-e063-6394a90a64482026-01-02WarningsExact identifier
unii: F5UM2KM3W7
Max OUTBENZALKONIUM CHLORIDEUnico475903d2-a0b0-5d29-e063-6394a90a528f2026-01-01WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic wipeBENZALKONIUM CHLORIDEYiwu Ori-Power Medtech Co.,Ltd.fc4fc127-3130-4891-b390-6dc823cb30d42026-01-01WarningsExact identifier
unii: F5UM2KM3W7
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEDr. Reddy's Laboratories, Inc.b1303f15-c48b-a44d-b28a-72f370094e022026-01-01Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
Ecolab Foaming Hand SanitizerBENZALKONIUM CHLORIDEEcolab Inc.7bc85519-64cb-48a3-bbd6-73e03b1d06112025-12-31WarningsExact identifier
unii: F5UM2KM3W7
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDE CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD470fca9f-a819-2290-e063-6294a90abad82025-12-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze ScentBENZALKONIUM CHLORIDEQuest USA Corpf6130f88-a274-4068-9d8e-5f898b3b074f2025-12-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Anti-bacterial Hand Wipes Honey Wildflower ScentBENZALKONIUM CHLORIDEQuest USA Corpd5db76a3-871e-4110-afc3-80f84a77eb2b2025-12-31WarningsExact identifier
unii: F5UM2KM3W7
BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 WipesBENZALKONIUM CHLORIDEQUEST USA CORP.ae2fdb32-05c6-6d16-e053-2995a90a552d2025-12-31WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.