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 15 of 112 · 2,238 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Care One Crisp CleanBENZALKONIUM CHLORIDERETAIL BUSINESS SERVICES , LLC25b33a18-0b14-5411-e063-6294a90a31ee2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Care One Fresh CitrusBENZALKONIUM CHLORIDERETAIL BUSINESS SERVICES , LLC25b338fc-8f03-5eb6-e063-6294a90aacc52026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Care One White Tea and BerryBENZALKONIUM CHLORIDERETAIL BUSINESS SERVICES , LLC25b385b5-bef8-b9c0-e063-6294a90ad4852026-05-08WarningsExact identifier
unii: F5UM2KM3W7
UP and UPBENZALKONIUM CHLORIDETARGET CORPORATION INC.39855595-cd79-a116-e063-6294a90a96382026-05-08WarningsExact identifier
unii: F5UM2KM3W7
berkley jensenBENZALKONIUM CHLORIDEApollo Health and Beauty Careda94f82d-42aa-41e8-e053-2995a90a83812026-05-08WarningsExact identifier
unii: F5UM2KM3W7
berkley jensenBENZALKONIUM CHLORIDEApollo Health and Beauty Careda96ccad-bf6d-7634-e053-2995a90abc472026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Simplify Clean and Protect Cool Splash LHSBENZALKONIUM CHLORIDERITE AID CORPORATION20d8b8a8-9d15-ad76-e063-6294a90a05212026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Hyvee LHSBWENZALKONIUM CHLORIDEApollo Health and Beauty Care42f5125b-3b72-4154-e063-6394a90a83c32026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Hyvee Foaming LHS-PearBENZALKONIUM CHLORIDEApollo Health and Beauty Care42f55d37-c234-acaa-e063-6394a90ae4532026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Discount Drug MartBENZALKONIUM CHLORIDEApollo Health and Beauty Care46b44696-8a1a-9ecf-e063-6394a90a42532026-05-08WarningsExact identifier
unii: F5UM2KM3W7
White TeaBENZALKONIUM CHLORIDEApollo Health and Beauty Care42f48f5b-40eb-ca73-e063-6294a90ae84a2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
AntibacterialBENZALKONIUM CHLORIDESante Manufacturing Inc3e52df25-deca-07d1-e054-00144ff88e882026-05-07WarningsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDESante Manufcaturing Inc3e5c5148-3196-2899-e054-00144ff8d46c2026-05-07WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
HandsoapBENZALKONIUM CHLORIDETopco Associates LLCe60ff14a-f78d-c9fa-e053-2995a90a7f102026-05-05WarningsExact identifier
unii: F5UM2KM3W7
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESomerset Therapeutics, LLCdfa48492-d83b-48cc-9ad1-bdc0c2ac99312026-05-05Warnings, Adverse reactionsExact identifier
unii: F850569PQR

Reported adverse events (FAERS/openFDA)#

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