FDA.reportPublic FDA data

Gromedi 5x Topical Spray

Manufacturer
Orange Lab
Effective date
2018-10-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:49:26

Label at a glance#

ProductGromedi 5x
Active ingredientMINOXIDIL
Label structure15 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredientActive ingredient

Ask a doctor

OTC - ASK DOCTOR SECTION

Ask a docAsk a doc

DO NOT USE IF

OTC - DO NOT USE SECTION

Do not use ifDo not use if

Maybe be harmful if used when pregnant or breast-feeding.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Pregnant or breast feedingPregnant or breast feeding

When using this product

OTC - WHEN USING SECTION

when using this productwhen using this product

Inactive ingredient

INACTIVE INGREDIENT SECTION

Inactive IngredientInactive Ingredient

Directions

INSTRUCTIONS FOR USE SECTION

DirectionsDirections

Do not use on children

WARNINGS AND PRECAUTIONS SECTION

do not use on childrendo not use on children

Directions for dosage / frequency

DOSAGE & ADMINISTRATION SECTION

dosagedosage

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

dosagedosage

Warnings section

warningswarnings

Indications and usage

INDICATIONS & USAGE SECTION

indicationindication

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

Purpose

OTC - PURPOSE SECTION

purposepurpose

Front display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

front panel imagefront panel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71331-104-042020-01-31C16284748780-19d75b9d0-bbe1-f424-e053-dadaa90a57ceGromedi 5x Topical Spray

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71331-104GROMEDI 5X (MINOXIDIL 5%) SPRAY [ORANGE LAB]3Legacy NDC20181010_741edbef-828c-7a86-e053-2a91aa0a76fb.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71331-10471331-104-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINOXIDIL5965120SH1ACTIB
APIGENIN7V515PI7F6IACT
BIOTINOYL TRIPEPTIDE-1O6380721VAIACT
SAW PALMETTOJ7WWH9M8QSIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
OLEANOLIC ACID6SMK8R7TGJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
URTICA DIOICA ROOTJ8HE8A6E5TIACT
PPG-26-BUTETH-262II1K6TZ4PIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BENZYL ALCOHOLLKG8494WBHIACT
BENZOIC ACID8SKN0B0MIMIACT
EDETATE SODIUMMP1J8420LUIACT
PANTHENOLWV9CM0O67ZIACT
BIOTIN6SO6U10H04IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
BEE PROPOLIS EXTRACT6Y8XYV2NOFIACT
PAULLINIA CUPANA SEEDC21GE7524RIACT
ASIAN GINSENGCUQ3A77YXIIACT
MENTHOLL7T10EIP3AIACT
CETRIMONIUM BROMIDEL64N7M9BWRIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
DEHYDROACETIC ACID2KAG279R6RIACT

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
4f10c234-4038-7d0b-e063-6294a90a5984741edbef-828c-7a86-e053-2a91aa0a76fb2026-04-09WarningsExact identifier
spl set id: 741edbef-828c-7a86-e053-2a91aa0a76fb

Reported adverse events (FAERS/openFDA)#

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