FDA.reportPublic FDA data

Phenyl-Lido

Manufacturer
Imprimis NJOF, LLC
Effective date
2020-02-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:32:17

Label at a glance#

ProductPhenyl-Lido
Active ingredientLIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure2 sections

Storage and handling

Store at 20° to 25° C (68° to 77° F)​

Label contents#

Full prescribing information#

STORAGE AND HANDLING SECTION


Store at 20° to 25° C (68° to 77° F)​

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vial LabelVial Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71384-650-012022-01-28C16284748780-19d75b9d0-ab61-f424-e053-dadaa90a57ce6e112b67-58d4-7f32-e053-2a91aa0a8cc5
71384-650-012020-02-12C16284748780-19d75b9d0-ab61-f424-e053-dadaa90a57ce6e112b67-58d4-7f32-e053-2a91aa0a8cc5
71384-650-012020-01-31C16284748780-19d75b9d0-ab61-f424-e053-dadaa90a57ce6e112b67-58d4-7f32-e053-2a91aa0a8cc5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71384-650-01Phenyl-Lido1 mL in 1 VIAL, GLASSINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71384-650PHENYL-LIDO (PHENYLEPHRINE HCL - LIDOCAINE HCL) INJECTION, SOLUTION [IMPRIMIS NJOF, LLC]2Legacy NDC, 1 package rows20200213_6e112b67-58d4-7f32-e053-2a91aa0a8cc5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71384-650-01ML - Milliliter71384-650e83a7844-2667-45f5-bd46-8088dc80c0cc12018-11-06

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
71384-65071384-650-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
9e647045-a8b6-4f3e-e053-2995a90a7a0b6e112b67-58d4-7f32-e053-2a91aa0a8cc52020-02-12Exact identifier
spl id: 9e647045-a8b6-4f3e-e053-2995a90a7a0b
spl set id: 6e112b67-58d4-7f32-e053-2a91aa0a8cc5

Reported adverse events (FAERS/openFDA)#

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