FDA.reportPublic FDA data

Instanyl Fentanyl Nasal Spray

Manufacturer
Renaissance Lakewood LLC
Effective date
2024-11-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 21:18:19

Label at a glance#

ProductInstanyl
Active ingredientFENTANYL CITRATE
Label structure1 sections

Label contents#

Full prescribing information#

Instanyl single dose nasal spray carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

instanyl single dose nasal spray cartoninstanyl single dose nasal spray carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3Product name120231002
a8df478d-5b88-9654-981b-87dff14dda8bProduct name220190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57Product name220180118
bb365072-425e-ca0a-021e-fd8b78162502Product name220161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6Product name220160104
739fa0ac-b690-63c4-9904-e20dffbf78f9Product name120140508
7763fcbb-367d-ed06-b37f-e1529b6241beProduct name120140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49396-0512INSTANYL (FENTANYL NASAL SPRAY) SPRAY [RENAISSANCE LAKEWOOD LLC]4Unmatched20241129_92c19d5a-0fe2-777d-e053-2995a90a4f3f.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
49396-051249396-0512-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
FENTANYL CITRATEMUN5LYG46HACTIM
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT

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
27e9d99b-6455-cf89-e063-6394a90a434792c19d5a-0fe2-777d-e053-2995a90a4f3f2024-11-27Exact identifier
spl id: 27e9d99b-6455-cf89-e063-6394a90a4347
spl set id: 92c19d5a-0fe2-777d-e053-2995a90a4f3f

Reported adverse events (FAERS/openFDA)#

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