Mydriatic-3

Manufacturer: Imprimis NJOF LLC
Effective date: 2018-05-08
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 00:54:53

Label at a glance#

ProductMydriatic-3

Active ingredientTROPICAMIDE, CYCLOPENTOLATE 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 Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71384-631-05	2020-02-12	C162847	48780-1	9d75b9d0-ab5e-f424-e053-dadaa90a57ce	6bb82e43-57f6-172e-e053-2991aa0a2e6e
71384-631-05	2020-01-31	C162847	48780-1	9d75b9d0-ab5e-f424-e053-dadaa90a57ce	6bb82e43-57f6-172e-e053-2991aa0a2e6e

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71384-631-05	ML - Milliliter	71384-631	8dbc177b-a155-4826-9ab6-7b241275c43a	1	2018-11-06

Products#

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

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

Mydriatic-3
Tropicamide - Cyclopentolate - Phenylephrine
TROPICAMIDE
CYCLOPENTOLATE HYDROCHLORIDE
CYCLOPENTOLATE
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71384-631	71384-631-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TROPICAMIDE	N0A3Z5XTC6	ACTIB
CYCLOPENTOLATE HYDROCHLORIDE	736I6971TE	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
6bb82e43-57f7-172e-e053-2991aa0a2e6e			6bb82e43-57f6-172e-e053-2991aa0a2e6e	2018-05-08		Exact identifier spl id: 6bb82e43-57f7-172e-e053-2991aa0a2e6e spl set id: 6bb82e43-57f6-172e-e053-2991aa0a2e6e

Reported adverse events (FAERS/openFDA)#

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