FDA.reportPublic FDA data

Raphe Pharmaceutique

Manufacturer
AmWiner & Raphe Holdings LLC
Effective date
2023-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:04

Label at a glance#

ProductRaphe Pharmaceutique
Active ingredientMINOXIDIL
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70ml NDC 82627-006-0170ml NDC 82627-006-01EXTRA STRENGTH MINOXIDIL SOLUTION FOR MEN & WOMEN

Active Ingredient: Minoxidil Sulfate 5% w/v

Purpose: Anti-Hair Loss

Uses: Helps Reactivate Hair Follicles, and Increase Hair Volume and Density

Helps Eliminate Recurrence of Hair Loss.

Warnings:

For external use only

Ask a doctor before use if condition covers a large area.

When using this product avoid contact with the eyes. If contact occurs, rinse your eyes thoroughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed.

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

Directions

Apply to affected area one ml two times daily or as directed by the physician!

Ingredients: Alcohol, Water, Propylene Glycol, Minoxidil, Acetyl Tyrosine, Panthenol, Green Tea Extract, Keratin Amino Acid, Isoflavone, Biotin, Ketoconazole, Coco amido-Propyl Betaine, Menthol, Zinc Pyrithione.

Other information: Store at 59° to 77°F (15° to 25°C)

For Questions Call 1-469-428-5508

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82627-006-022025-01-30C16284748780-11030e365-43b5-111a-e063-dadaa90a10e2046749f3-2539-d084-e063-6294a90a53b5
82627-006-022024-01-30C16284748780-11030e365-43b5-111a-e063-dadaa90a10e2046749f3-2539-d084-e063-6294a90a53b5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82627-006-01Raphe Pharmaceutique50 mg in 1 BOTTLE, DROPPERLIQUID501
82627-006-02Raphe Pharmaceutique1 in 1 BOXLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82627-006RAPHE PHARMACEUTIQUE (MINOXIDIL) LIQUID [AMWINER & RAPHE HOLDINGS LLC]12 package rows20230903_046749f3-2539-d084-e063-6294a90a53b5.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82627-00682627-006-01, 82627-006-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MINOXIDIL5965120SH1ACTIB

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
046749f3-253a-d084-e063-6294a90a53b5046749f3-2539-d084-e063-6294a90a53b52023-09-02Exact identifier
spl id: 046749f3-253a-d084-e063-6294a90a53b5
spl set id: 046749f3-2539-d084-e063-6294a90a53b5

Reported adverse events (FAERS/openFDA)#

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