FDA.reportPublic FDA data

DEXAMETHASONE SODIUM PHOSPHATE 0.1% / FINASTERIDE 0.1% / MINOXIDIL 5%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-08
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:38

Label at a glance#

ProductDEXAMETHASONE SODIUM PHOSPHATE 0.1% / FINASTERIDE 0.1% / MINOXIDIL 5%
Active ingredientMINOXIDIL, FINASTERIDE, DEXAMETHASONE SODIUM PHOSPHATE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

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Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

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Active, inactive

COMPONENTS

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NDC 72934-4069-8 DEXAMETHASONE SODIUM PHOSPHATE USP 0.1% / FINASTERIDE USP 0.1% / MINOXIDIL USP 5% . Solution 60 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXAMETHASONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
FINASTERIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MINOXIDIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
d00474ae-23eb-a8eb-bf56-520e590cc6dbProduct name220170406
0f90664c-9d0e-f046-dc6a-73563cd8347eProduct name220170405
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-4069-82021-01-29C16284748780-1ba0f9c33-594f-a910-e053-dadaa90a0b85DEXAMETHASONE SODIUM PHOSPHATE 0.1% / FINASTERIDE 0.1% / MINOXIDIL 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-4069-8DEXAMETHASONE SODIUM PHOSPHATE 0.1% / FINASTERIDE 0.1% / MINOXIDIL 5%60 g in 1 BOTTLE, GLASSSOLUTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-4069DEXAMETHASONE SODIUM PHOSPHATE 0.1% / FINASTERIDE 0.1% / MINOXIDIL 5% SOLUTION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190509_8861bc75-99f3-44f2-e053-2a95a90a1fe0.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-406972934-4069-8

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
NameUNIIKind
MINOXIDIL5965120SH1ACTIB
FINASTERIDE57GNO57U7GACTIB
DEXAMETHASONE SODIUM PHOSPHATEAI9376Y64PACTIR

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
8861bc75-99f4-44f2-e053-2a95a90a1fe08861bc75-99f3-44f2-e053-2a95a90a1fe02019-05-08Adverse reactionsExact identifier
spl id: 8861bc75-99f4-44f2-e053-2a95a90a1fe0
spl set id: 8861bc75-99f3-44f2-e053-2a95a90a1fe0

Reported adverse events (FAERS/openFDA)#

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