FDA.reportPublic FDA data

UNDA 47

Manufacturer
Seroyal USA | SAN’UP
Effective date
2022-11-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:18:26

Label at a glance#

ProductUNDA 43
Active ingredientEQUISETUM ARVENSE TOP, JATEORHIZA CALUMBA ROOT, GALIUM ODORATUM, MARRUBIUM VULGARE, BASIL, TIN, ALUMINUM, THYMUS VULGARIS WHOLE, VALERIAN, WORMWOOD, ARNICA MONTANA ROOT, GOLD, ROSEMARY, ANTIMONY
Label structure24 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Each drop contains:

Absinthium (Common wormwood) Aerial Parts 6X
Arnica montana (Mountain arnica) Underground Parts 6X
Aurum metallicum (Gold) 12X
Jateorhiza palmata (Columbo) Root 6X
Rosmarinus officinalis (Rosemary) Leaf 6X
Stibium metallicum (Antimony) 15X
Thymus vulgaris Aerial Parts 6X
Valeriana officinalis (Valerian) Root 6X

OTC - PURPOSE SECTION

Uses
For the temporary relief of symptoms associated with dizziness, mental fatigue and 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 - 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.

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

UsesUses
For the temporary relief of symptoms associated with dizziness, mental fatigue and 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.

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Each drop contains:

Aluminium metallicum (Aluminum) 12X
Asperula odorata (Sweet woodruff) Aerial Parts 4X
Equisetum arvense (Common horsetail) Stem 4X
Jateorhiza palmata (Columbo) Root 4X
Marrubium vulgare (Common horehound) Aerial Parts 4X
Ocimum basilicum Aerial Parts 4X
Stannum metallicum (Tin) 12X

OTC - PURPOSE SECTION

Uses

For the temporary relief of symptoms associated with poor digestion.

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.

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 poor digestion.

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

62106-114662106-1146

NDC 62106-1146-8

UNDA

numbered compounds
UNDA 47
Homeopathic Preparation

For the temporary relief of symptoms
associated with dizziness, mental
fatigue and nervousness.
Contains 31% Alcohol
0.7 fl oz (20 ml)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62106-114262106-1142

NDC 62106-1142-8

UNDA
numbered compounds
UNDA 43
Homeopathic Preparation

For the temporary relief of symptoms
associated with poor digestion.
Contains 31% Alcohol
0.7 fl oz (20 ml)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1142-8UNDA 431 in 1 CARTONLIQUID15
62106-1142-8UNDA 4320 mL in 1 BOTTLE, GLASSLIQUID205
62106-1146-8UNDA 471 in 1 CARTONLIQUID15
62106-1146-8UNDA 4720 mL in 1 BOTTLE, GLASSLIQUID205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1142UNDA 43 (ALUMINIUM METALLICUM, ASPERULA ODORATA, EQUISETUM ARVENSE, JATEORHIZA PALMATA, MARRUBIUM VULGARE, OCIMUM BASILICUM, STANNUM METALLICUM) LIQUID UNDA 47 (ABSINTHIUM, ARNICA MONTANA, AURUM METALLICUM, JATEORHIZA PALMATA, ROSMARINUS OFFICINALIS, STIBIUM METALLICUM, THYMUS VULGARIS, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]5Current NDC, Legacy NDC, 2 package rows20221110_20569964-d505-03e2-e054-00144ff8d46c.zip
62106-1146UNDA 43 (ALUMINIUM METALLICUM, ASPERULA ODORATA, EQUISETUM ARVENSE, JATEORHIZA PALMATA, MARRUBIUM VULGARE, OCIMUM BASILICUM, STANNUM METALLICUM) LIQUID UNDA 47 (ABSINTHIUM, ARNICA MONTANA, AURUM METALLICUM, JATEORHIZA PALMATA, ROSMARINUS OFFICINALIS, STIBIUM METALLICUM, THYMUS VULGARIS, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]5Current NDC, Legacy NDC, 2 package rows20221110_20569964-d505-03e2-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUMACTIVE INGREDIENTCPD4NFA9032
ANTIMONYACTIVE INGREDIENT9IT35J3UV32
ARNICA MONTANA ROOTACTIVE INGREDIENTMUE8Y113272
BASILACTIVE INGREDIENT2U0KZP0FDW2
EQUISETUM ARVENSE TOPACTIVE INGREDIENT1DP6Y6B65Z2
GALIUM ODORATUMACTIVE INGREDIENTN8C4A9A49H2
GOLDACTIVE INGREDIENT79Y1949PYO2
JATEORHIZA CALUMBA ROOTACTIVE INGREDIENTV36I2B8LD52
MARRUBIUM VULGAREACTIVE INGREDIENT7A72MUN24Z2
ROSEMARYACTIVE INGREDIENTIJ67X351P92
THYMUS VULGARIS WHOLEACTIVE INGREDIENT8L72OKJ7II2
TINACTIVE INGREDIENT387GMG9FH52
VALERIANACTIVE INGREDIENTJWF5YAW3QW2
WORMWOODACTIVE INGREDIENTF84709P2XV2
ALUMINUMACTIVE MOIETYCPD4NFA9032
ANTIMONYACTIVE MOIETY9IT35J3UV32
ARNICA MONTANA ROOTACTIVE MOIETYMUE8Y113272
BASILACTIVE MOIETY2U0KZP0FDW2
EQUISETUM ARVENSE TOPACTIVE MOIETY1DP6Y6B65Z2
GALIUM ODORATUMACTIVE MOIETYN8C4A9A49H2
GOLDACTIVE MOIETY79Y1949PYO2
JATEORHIZA CALUMBA ROOTACTIVE MOIETYV36I2B8LD52
MARRUBIUM VULGAREACTIVE MOIETY7A72MUN24Z2
ROSEMARYACTIVE MOIETYIJ67X351P92
THYMUS VULGARIS WHOLEACTIVE MOIETY8L72OKJ7II2
TINACTIVE MOIETY387GMG9FH52
VALERIANACTIVE MOIETYJWF5YAW3QW2
WORMWOODACTIVE MOIETYF84709P2XV2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62106-114262106-1142-8
62106-114662106-1146-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
EQUISETUM ARVENSE TOP1DP6Y6B65ZACTIB
JATEORHIZA CALUMBA ROOTV36I2B8LD5ACTIB
GALIUM ODORATUMN8C4A9A49HACTIB
MARRUBIUM VULGARE7A72MUN24ZACTIB
BASIL2U0KZP0FDWACTIB
TIN387GMG9FH5ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ALUMINUMCPD4NFA903ACTIB
THYMUS VULGARIS WHOLE8L72OKJ7IIACTIB
VALERIANJWF5YAW3QWACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
WORMWOODF84709P2XVACTIB
ARNICA MONTANA ROOTMUE8Y11327ACTIB
GOLD79Y1949PYOACTIB
JATEORHIZA CALUMBA ROOTV36I2B8LD5ACTIB
ROSEMARYIJ67X351P9ACTIB
ANTIMONY9IT35J3UV3ACTIB

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 43ALUMINIUM METALLICUM, ASPERULA ODORATA, EQUISETUM ARVENSE, JATEORHIZA PALMATA, MARRUBIUM VULGARE, OCIMUM BASILICUM, STANNUM METALLICUMSeroyal USA20569964-d505-03e2-e054-00144ff8d46c2022-11-09WarningsExact identifier
ndc (package): 62106-1146-8
ndc (package): 62106-1142-8
ndc (product): 62106-1146
ndc (product): 62106-1142
ndc11 (package): 62106114608
ndc11 (package): 62106114208
spl id: ed10aff6-7a4c-4115-e053-2995a90a9d1a
spl set id: 20569964-d505-03e2-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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