FDA.reportPublic FDA data

UNDA 202

Manufacturer
Seroyal USA | SAN’UP
Effective date
2021-07-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:14:43

Label at a glance#

ProductUNDA 210
Active ingredientPEUMUS BOLDUS LEAF, CRATAEGUS FRUIT, LACTUCA VIROSA, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, CALCIUM FLUORIDE, COPPER, GELSEMIUM SEMPERVIRENS WHOLE, SULFUR, GOLD
Label structure24 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Each drop contains:
Aurum metallicum (Gold) 12X
Calcarea fluorica (Calcium fluoride)12X
Cuprum metallicum (Copper) 12X
Gelsemium sempervirens (Yellow jessamine) Underground Parts 4X
Sulphur (Sublimed sulfur) 6X

OTC - PURPOSE SECTION

Uses
For the temporary relief of symptoms associated with
low energy
fatigue

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 - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive ingredients
Ethanol (beet), purified water

OTHER SAFETY INFORMATION

Other information
Do not use if seal is missing or broken.

Store in a cool, dry place.

Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity.

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
For the temporary relief of symptoms associated with
low energy
fatigue

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.

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Each drop contains:

Boldo Leaf 4X
Crataegus (Hawthorn) Fruit 4X
Lactuca virosa (Poisonous lettuce) Whole Plant 4X
Passiflora incarnata (Passion flower) Aerial Parts 4X
Valeriana officinalis (Valerian) Root 4X

OTC - PURPOSE SECTION

Uses
For the temporary relief of symptoms associated with mild anxiety and irritability

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 - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive ingredients
Ethanol (beet), purified water

OTHER SAFETY INFORMATION

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

Contents may not fill package in order
to accommodate required labeling.
Please rely on stated quantity.

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
For the temporary relief of symptoms associated with mild anxiety and irritability

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

62106-117662106-1176

NDC 62106-1176-8

UNDA
numbered compounds
UNDA 202
Homeopathic Preparation

For the temporary relief of symptoms
associated with low energy and fatigue.
Contains 32% Alcohol
0.7 fl oz (20 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62106-1154-862106-1154-8

NDC 62106-1154-8

UNDA
numbered compounds
UNDA 210
Homeopathic Preparation

For the temporary relief of symptoms
associated with mild anxiety and irritability.
Contains 31% Alcohol
0.7 fl oz (20 ml)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1154-8UNDA 21020 mL in 1 BOTTLE, GLASSLIQUID206
62106-1154-8UNDA 2101 in 1 CARTONLIQUID16
62106-1176-8UNDA 20220 mL in 1 BOTTLE, GLASSLIQUID206
62106-1176-8UNDA 2021 in 1 CARTONLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1154UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID UNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID [SEROYAL USA]6Current NDC, Legacy NDC, 2 package rows20210717_205b68ed-ff41-3559-e054-00144ff88e88.zip
62106-1176UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID UNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID [SEROYAL USA]6Current NDC, Legacy NDC, 2 package rows20210717_205b68ed-ff41-3559-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKI2
COPPERACTIVE INGREDIENT789U1901C52
CRATAEGUS FRUITACTIVE INGREDIENTQ21UUL21052
GELSEMIUM SEMPERVIRENS WHOLEACTIVE INGREDIENTR0519OZO3K2
GOLDACTIVE INGREDIENT79Y1949PYO2
LACTUCA VIROSAACTIVE INGREDIENT6D74QW4H672
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11O2
PEUMUS BOLDUS LEAFACTIVE INGREDIENTQ4EWM09M3O2
SULFURACTIVE INGREDIENT70FD1KFU702
VALERIANACTIVE INGREDIENTJWF5YAW3QW2
COPPERACTIVE MOIETY789U1901C52
CRATAEGUS FRUITACTIVE MOIETYQ21UUL21052
FLUORIDE IONACTIVE MOIETYQ80VPU408O2
GELSEMIUM SEMPERVIRENS WHOLEACTIVE MOIETYR0519OZO3K2
GOLDACTIVE MOIETY79Y1949PYO2
LACTUCA VIROSAACTIVE MOIETY6D74QW4H672
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11O2
PEUMUS BOLDUS LEAFACTIVE MOIETYQ4EWM09M3O2
SULFURACTIVE MOIETY70FD1KFU702
VALERIANACTIVE MOIETYJWF5YAW3QW2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62106-117662106-1176-8
62106-115462106-1154-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEUMUS BOLDUS LEAFQ4EWM09M3OACTIB
CRATAEGUS FRUITQ21UUL2105ACTIB
LACTUCA VIROSA6D74QW4H67ACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
VALERIANJWF5YAW3QWACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
CALCIUM FLUORIDEO3B55K4YKIACTIB
COPPER789U1901C5ACTIB
GELSEMIUM SEMPERVIRENS WHOLER0519OZO3KACTIB
SULFUR70FD1KFU70ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
GOLD79Y1949PYOACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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 210BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALISSeroyal USA205b68ed-ff41-3559-e054-00144ff88e882021-07-15WarningsExact identifier
ndc (package): 62106-1154-8
ndc (package): 62106-1176-8
ndc (product): 62106-1154
ndc (product): 62106-1176
ndc11 (package): 62106117608
ndc11 (package): 62106115408
spl id: c7335cbe-8359-b482-e053-2a95a90a24ac
spl set id: 205b68ed-ff41-3559-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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