UNDA 219

Manufacturer
Seroyal USA | SAN’UP
Effective date
2022-11-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:18:28

Label at a glance#

ProductUNDA 219
Active ingredientLACTUCA VIROSA, CRATAEGUS FRUIT, THYME, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Each drop contains:
Crataegus (Hawthorn) Fruit 4X
Lactuca virosa (Poisonous lettuce) Whole Plant 4X
Passiflora incarnata (Passion flower) Aerial Parts 4X
Thymus vulgaris Aerial Parts 4X
Valeriana officinalis (Valerian) Root 4X

OTC - PURPOSE SECTION

Uses
Helps to promote relaxation and temporarily relieve mild nervousness

WARNINGS SECTION

Warnings
Stop use and ask a doctor if symptoms persist or worsen.

If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTHER SAFETY INFORMATION

Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Ethanol (beet), purified water

DOSAGE & ADMINISTRATION SECTION

Directions
Adults and adolescents (12 years and older)

Take 5 drops three times daily or as recommended by your healthcare practitioner.

Children (under 12 years)

Take under the direction of your healthcare practitioner

INDICATIONS & USAGE SECTION

Uses
Helps to promote relaxation and temporarily relieve mild nervousness

Directions
Adults and adolescents (12 years and older): Take 5 drops three times daily or as
recommended by your healthcare practitioner.
Children (under 12 years): Take under the direction of your
healthcare practitioner.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62106-115662106-1156

NDC 62106-1156-8

UNDA

numbered compounds

UNDA 219

Homeopathic Preparation

Helps to promote relaxation and temporarily relieve mild nervousness.

Contains 31% Alcohol
0.7 fl oz (20 ml)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1156-8UNDA 21920 mL in 1 BOTTLE, GLASSLIQUID204
62106-1156-8UNDA 2191 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1156UNDA 219 (CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, THYMUS VULGARIS, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]4Current NDC, Legacy NDC, 2 package rows20221110_2f0cd4d0-55ab-64b4-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62106-115662106-1156-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
UNDA 219CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, THYMUS VULGARIS, VALERIANA OFFICINALISSeroyal USA2f0cd4d0-55ab-64b4-e054-00144ff8d46c2022-11-09WarningsExact identifier
ndc (package): 62106-1156-8
ndc (product): 62106-1156
ndc11 (package): 62106115608
spl id: ed10cda7-03ea-2f5e-e053-2a95a90a0500
spl set id: 2f0cd4d0-55ab-64b4-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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