FDA.reportPublic FDA data

Naloxone

Manufacturer
Summit Biosciences Inc.
Effective date
2023-12-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:00:00

Label at a glance#

ProductNaloxone
Active ingredientNALOXONE HYDROCHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

SPL PATIENT PACKAGE INSERT SECTION

Naloxone 10 mgNaloxone 10 mg

TRADENAME (Naloxone Hydrochloride) Nasal Spray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Naloxone 10 mgNaloxone 10 mgNaloxone 10 mgNaloxone 10 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43674-003NALOXONE SPRAY [SUMMIT BIOSCIENCES INC.]3Unmatched20240628_f94cafac-ac41-d390-e053-6394a90a4dfa.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43674-00343674-003-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
HYDROCHLORIC ACIDQTT17582CBIACT
NALOXONE HYDROCHLORIDEF850569PQRACTIB
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

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
eb9cd2b0-0884-42ab-94db-771490db90a9f94cafac-ac41-d390-e053-6394a90a4dfa2025-05-22Exact identifier
spl set id: f94cafac-ac41-d390-e053-6394a90a4dfa

Reported adverse events (FAERS/openFDA)#

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