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 29 of 111 · 2,218 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Covex Antibacterial Hand Wash Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19157f-b1e0-1142-e053-2a95a90a2ceb2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Hand Wash Fresh ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19269c-cd28-f12f-e053-2a95a90ab0162026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Liquid Hand Wash Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19157f-b1e2-1142-e053-2a95a90a2ceb2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
BZK AntisepticBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.698ed472-9204-46e3-95a4-d59e204628ac2026-01-21WarningsExact identifier
unii: F5UM2KM3W7
LIGHTS SwabstickBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.9346512e-53a1-420a-8b4d-bfbec32576a22026-01-21WarningsExact identifier
unii: F5UM2KM3W7
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution48d73434-e65b-dc98-e063-6294a90affa22026-01-20Adverse reactionsExact identifier
unii: 451W47IQ8X
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
EQUATE PREMIUM SALINESODIUM CHLORIDE 0.65%Walmart Stores, Inc.1e17f022-f513-140d-e063-6394a90a379e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCd98bf9f7-30ec-4927-a577-cabad192cb182026-01-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Walgreens Antibacterial Hand WipesBENZALKONIUM CHLORIDEWalgreen Co.61aed8f1-ddf6-41d0-9d12-8affc43265d62026-01-15WarningsExact identifier
unii: F5UM2KM3W7
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
unii: 451W47IQ8X
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLC0e1f57c4-8b46-b8cc-e063-6294a90a0ebb2026-01-15WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3afde78-b9f6-3648-e053-2a95a90a40242026-01-15WarningsExact identifier
unii: F5UM2KM3W7
Caring HandsHAND MOISTURIZING SANITIZERGleeco Labs LLC2ced5dc5-47dd-1b71-e063-6394a90a0e3d2026-01-14WarningsExact identifier
unii: F5UM2KM3W7
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAvKARE1766a7f1-d301-945f-e063-6294a90ac6f42026-01-14WarningsExact identifier
application number: ANDA217992
rxcui: 1725059
unii: F850569PQR
Hy-Vee LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care3f82ea8b-87cf-fd28-e063-6394a90a50152026-01-13WarningsExact identifier
unii: F5UM2KM3W7
RENOWN Antibacterial Plum HandwashBENZALKONIUM CHLORIDEHome Depot U.S.A., Inc.b577c676-10d0-4b4a-ace8-4e21a771929d2026-01-13WarningsExact identifier
unii: F5UM2KM3W7
Antimicrobial Foaming Hand SanitizerBENZALKONIUM CHLORIDESaraya Healthcare3075e40b-41c3-56c6-e054-00144ff88e882026-01-13WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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