FDA.reportPublic FDA data

NDC 69238-2104-01 - 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
69238-2104
Requested NDC
69238-2104-01
Package NDCs from labels
69238-2104-1, 69238-2104-7, 69238-2104-01
Manufacturer
Amneal Pharmaceuticals LLC
Effective date
2026-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naloxone Hydrochloride - Amneal Pharmaceuticals LLCAmneal Pharmaceuticals LLC2026-08-25HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2104-1Naloxone Hydrochloride0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.111
69238-2104-7Naloxone Hydrochloride2 in 1 CARTONSPRAY211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2104NALOXONE HYDROCHLORIDE SPRAY [AMNEAL PHARMACEUTICALS NY LLC]8Current NDC, 2 package rows20240502_8091a73d-9ecd-4578-a57b-5d85a2c5a16a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2104-1EA - Each69238-210491ff8fe2-0e79-477f-b698-28929742cf6512024-05-16
69238-2104-7EA - Each69238-210406b3edfc-7c4e-46db-a6cc-917639d8c9bf12024-05-16

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 24 of 111 · 2,218 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand WashBENZALKONIUM CHLORIDEMeijer, Inc.df4dbf38-669a-441a-bd6e-f5cc490d17d22026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Meijer, Inc.fbfb9940-0c17-4fdf-81f5-406d614da8722026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antiseptic Foaming Hand SanitizerBENZALKONIUM CHLORIDETarget Corporation93d6e4df-9428-4557-b251-c7aa9bda34122026-02-18Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideFIRST AID ANTISEPTIC FOAMTarget Corporation4599eb25-2877-fc62-e063-6294a90a5d182026-02-18Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideBENZALKONIUM CHLORIDES. P. Richards Company9223a236-9e9e-42eb-a945-dfe629e4ae3f2026-02-18Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEWalmart Inc.25d227f8-2238-4f6f-aa40-b314d0179d882026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Light Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%United Natural Foods, Inc. dba UNFI36738761-293e-4864-bc08-87a5075e1ccf2026-02-17WarningsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEUnited Natural Foods, Inc. dba UNFI2757aafa-9d03-4ad0-9b6b-8cb9ef3cdd902026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDE 0.13%Uline57c7bf8f-c17a-41b5-9b66-e4d16d6650a72026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEULINE5a4d6fb7-486a-448c-b379-726adf60e4112026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WashBENZALKONIUM CHLORIDE 0.13%Uline9e7a97a0-f3dd-40cf-b25e-8ebb656939262026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Foaming HandBENZALKONIUM CHLORIDEVeritiv Operating Company3b4dbfd0-f275-3502-e063-6294a90a84862026-02-16Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEVeritiv Operating Company3b4f27c8-6a1c-2823-e063-6294a90a47ad2026-02-16Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC087ac43c-1076-d1e2-e063-6294a90a58592026-02-16WarningsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Valu Merchandisers Companyfb9071d7-e44a-47fc-b76d-faf6220a57bf2026-02-16Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Dealmed BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEDealmed Medical Supplies, LLC.90a16a08-a7bf-418d-a95e-d735fb179a702026-02-16WarningsExact identifier
unii: F5UM2KM3W7
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: 451W47IQ8X
Benzalkonium chlorideBENZALKONIUM CHLORIDE 0.13%Wakefern Food Corp.d4e823bc-527b-4815-a7e0-47ee8d004e632026-02-13Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideBENZALKONIUM CHLORIDE 0.13%Your Military Exchanges8dd3bb4d-9cb5-4994-9c77-fa5b8e69ec2b2026-02-12Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Cucumber Mint BlissBENZALKONIUM CHLORIDER & R Lotion, Inc458dec24-b5bb-240a-e063-6294a90a81f32026-02-11WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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