FDA.reportPublic FDA data

Vagical

Manufacturer
Farmina sp. z o.o.
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:31:43

Label at a glance#

ProductVagical
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure9 sections

Indications and uses

For temporary relief of minor symptoms of vaginitis, such as itching, burning and irritation.

Dosage and administration

Adults 18 years and up: Wash hands before and after use. Before use, damp insert with water that has been previously boiled and cooled. Place one insert into vagina 2-3 times per day. Children 12-18 years: Consult a doctor before use. Under 12 years of age: Do not use

Storage and handling

do not store above 77 degrees F (25 degrees C)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Calendula officinalis TINC HPUS*

*The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

OTC - PURPOSE SECTION

Healing agent and anti-inflammatory

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor symptoms of vaginitis, such as itching, burning and irritation.

Warnings

WARNINGS SECTION

For vaginal use only

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic (hypersensitive) to any of the ingredients found in the insert
  • after expiration date on carton

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • strong vaginal discharge
  • vaginal bleeding

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you arepresently taking other vaginal insert drug products

OTC - WHEN USING SECTION

When using this productdo not exceed recommended dose.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • no improvement is seen after three to four days
  • your symptoms worsen
  • you experience irritation from using the product

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding,ask a health professional before use.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults 18 years and up: Wash hands before and after use. Before use, damp insert with water that has been previously boiled and cooled. Place one insert into vagina 2-3 times per day.
  • Children 12-18 years: Consult a doctor before use.
  • Under 12 years of age: Do not use

Other information

STORAGE AND HANDLING SECTION

do not store above 77 degrees F (25 degrees C)

Inactive ingredient

INACTIVE INGREDIENT SECTION

Polyethylene Glycol.

PRINCIPAL DISPLAY PANEL - 10 Insert Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vagical ®

NDC 68984-001-10

Nature's answer
for vaginal:

  • itching
  • burning
  • irritation
  • dryness

Original French
Marigold Extract

10 VAGINAL INSERTS

PRINCIPAL DISPLAY PANEL - 10 Insert Box
PRINCIPAL DISPLAY PANEL - 10 Insert Box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68984-001-102024-01-30C16284748780-11030e365-37d7-111a-e063-dadaa90a10e2Vagical

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68984-001-10Vagical10 in 1 PACKAGEINSERT107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68984-001VAGICAL (CALENDULA OFFICINALIS FLOWERING TOP) INSERT [FARMINA SP. Z O.O.]7Current NDC, Legacy NDC, 1 package rows20250131_0ab35c03-942e-4ba5-ba5a-65c5a99830d7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ3
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A3

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68984-00168984-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB

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
VagicalCALENDULA OFFICINALIS FLOWERING TOPFarmina sp. z o.o.0ab35c03-942e-4ba5-ba5a-65c5a99830d72025-01-30WarningsExact identifier
ndc (package): 68984-001-10
ndc (product): 68984-001
ndc11 (package): 68984000110
spl id: 2cec9c90-2e50-f005-e063-6294a90a8753
spl set id: 0ab35c03-942e-4ba5-ba5a-65c5a99830d7

Reported adverse events (FAERS/openFDA)#

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