FDA.reportPublic FDA data

Mydriatic-4

Manufacturer
Imprimis NJOF, LLC
Effective date
2018-05-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:25:51

Label at a glance#

ProductMydriatic-4
Active ingredientTROPICAMIDE, KETOROLAC TROMETHAMINE, PROPARACAINE 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

Bottle LabelBottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOROLAC Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PROPARACAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
TROPICAMIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
9ba0893a-4390-4124-b66b-ffd4f2b29a0eProduct name220260305
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
6e36a95f-fcff-e2d1-3f9b-17d0b7f9e28cProduct name220200603
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
41722ce4-2429-80d8-5977-d735f8eca6d6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71384-632-052020-01-31C16284748780-19d75b9cf-cf5c-f424-e053-dadaa90a57ce6e11c346-99d6-e440-e053-2991aa0a79b5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71384-632-05Mydriatic-45 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71384-632MYDRIATIC-4 (TROPICAMIDE - PROPARACINE - PHENYLEPHRINE - KETOROLAC) SOLUTION/ DROPS [IMPRIMIS NJOF, LLC]1Legacy NDC, 1 package rows20180607_6e11c346-99d6-e440-e053-2991aa0a79b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71384-632-05ML - Milliliter71384-6329fca8ff0-c4c4-4518-9956-41acdfcf034912018-11-06

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71384-63271384-632-05

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
TROPICAMIDEN0A3Z5XTC6ACTIB
KETOROLAC TROMETHAMINE4EVE5946BQACTIB
PROPARACAINE HYDROCHLORIDEU96OL57GOYACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML · Source PDF

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
6e11c346-99d7-e440-e053-2991aa0a79b56e11c346-99d6-e440-e053-2991aa0a79b52018-05-01Exact identifier
spl id: 6e11c346-99d7-e440-e053-2991aa0a79b5
spl set id: 6e11c346-99d6-e440-e053-2991aa0a79b5

Reported adverse events (FAERS/openFDA)#

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