FDA.reportPublic FDA data

UNDA 34

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 28
Active ingredientSARSAPARILLA, FILIPENDULA ULMARIA ROOT, ALUMINUM, COPPER, TIN, MARSDENIA CONDURANGO BARK, TARAXACUM OFFICINALE WHOLE, LACTUCA VIROSA, HOPS, JUNIPERUS COMMUNIS WHOLE, EQUISETUM ARVENSE BRANCH, GOLDENSEAL, SYZYGIUM CUMINI SEED, GOLD
Label structure24 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Each drop contains:
Aluminium metallicum (Aluminum) 12X
Condurango Bark 4X
Cuprum metallicum (Copper) 12X
Lactuca virosa (Poisonous lettuce) Whole Plant 4X
Sarsaparilla Root 4X
Spiraea ulmaria (Queen-of-the-meadow) Underground Parts 4X
Stannum metallicum (Tin) 12X
Taraxacum officinale (Common dandelion) Whole Plant 4X

OTC - PURPOSE SECTION

Uses
For the temporary relief of minor joint, muscle and bone pain.

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 - 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.

OTC - ASK DOCTOR SECTION

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

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 minor joint, muscle and bone pain.

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:
Aurum metallicum (Gold) 12X
Equisetum arvense (Common horsetail) Stem 4X
Humulus lupulus (Hops) Inflorescences 4X
Hydrastis canadensis (Golden seal) Rhizome and Root 4X
Juniperus communis (Common juniper) Berry 4X
Syzygium jambolanum (Jambol seed) Fruit 4X

OTC - PURPOSE SECTION

Uses
For the temporary relief of fatigue and sleepiness after meals associated with thirst.

WARNINGS SECTION

Warnings
Stop use and ask a doctor if symptoms persist or worsen.
If pregnant or breastfeeding, ask a healthcare 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 - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare 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.

OTC - ASK DOCTOR SECTION

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

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 fatigue and sleepiness after meals associated with thirst.

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

62106-112762106-1127

NDC 62106-1127-8

UNDA

numbered compounds

UNDA 28

Homeopathic Preparation

For the temporary relief of minor joint,

muscle and bone pain.

Contains 31% Alcohol
0.7 fl oz (20 ml)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62106-113362106-1133

NDC 62106-1133-8

UNDA

numbered compounds

UNDA 34

Homeopathic Preparation

For the temporary relief of fatigue and
sleepiness after meals associated with thirst.

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
62106-1127-8UNDA 2820 mL in 1 BOTTLE, GLASSLIQUID205
62106-1127-8UNDA 281 in 1 CARTONLIQUID15
62106-1133-8UNDA 341 in 1 CARTONLIQUID15
62106-1133-8UNDA 3420 mL in 1 BOTTLE, GLASSLIQUID205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1127UNDA 28 (LACTUCA VIROSA, TARAXACUM OFFICINALE, SARSAPARILLA, SPIRAEA ULMARIA, CONDURANGO, ALUMINIUM METALLICUM, CUPRUM METALLICUM, STANNUM METALLICUM) LIQUID UNDA 34 (HUMULUS LUPULUS, JUNIPERUS COMMUNIS, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, SYZYGIUM JAMBOLANUM, AURUM METALLICUM) LIQUID [SEROYAL USA]5Current NDC, Legacy NDC, 2 package rows20221110_182f4ad8-edf9-468c-e054-00144ff8d46c.zip
62106-1133UNDA 28 (LACTUCA VIROSA, TARAXACUM OFFICINALE, SARSAPARILLA, SPIRAEA ULMARIA, CONDURANGO, ALUMINIUM METALLICUM, CUPRUM METALLICUM, STANNUM METALLICUM) LIQUID UNDA 34 (HUMULUS LUPULUS, JUNIPERUS COMMUNIS, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, SYZYGIUM JAMBOLANUM, AURUM METALLICUM) LIQUID [SEROYAL USA]5Current NDC, Legacy NDC, 2 package rows20221110_182f4ad8-edf9-468c-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUMACTIVE INGREDIENTCPD4NFA9032
COPPERACTIVE INGREDIENT789U1901C52
EQUISETUM ARVENSE BRANCHACTIVE INGREDIENT1L0VKZ185E2
FILIPENDULA ULMARIA ROOTACTIVE INGREDIENT997724QNDS2
GOLDACTIVE INGREDIENT79Y1949PYO2
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JV2
HOPSACTIVE INGREDIENT01G73H6H832
JUNIPERUS COMMUNIS WHOLEACTIVE INGREDIENT464910T5N92
LACTUCA VIROSAACTIVE INGREDIENT6D74QW4H672
MARSDENIA CONDURANGO BARKACTIVE INGREDIENTR23QIR6YBA2
SARSAPARILLAACTIVE INGREDIENT2H1576D5WG2
SYZYGIUM CUMINI SEEDACTIVE INGREDIENT820LSF646I2
TARAXACUM OFFICINALE WHOLEACTIVE INGREDIENT7C42E2D7B02
TINACTIVE INGREDIENT387GMG9FH52
ALUMINUMACTIVE MOIETYCPD4NFA9032
COPPERACTIVE MOIETY789U1901C52
EQUISETUM ARVENSE BRANCHACTIVE MOIETY1L0VKZ185E2
FILIPENDULA ULMARIA ROOTACTIVE MOIETY997724QNDS2
GOLDACTIVE MOIETY79Y1949PYO2
GOLDENSEALACTIVE MOIETYZW3Z11D0JV2
HOPSACTIVE MOIETY01G73H6H832
JUNIPERUS COMMUNIS WHOLEACTIVE MOIETY464910T5N92
LACTUCA VIROSAACTIVE MOIETY6D74QW4H672
MARSDENIA CONDURANGO BARKACTIVE MOIETYR23QIR6YBA2
SARSAPARILLAACTIVE MOIETY2H1576D5WG2
SYZYGIUM CUMINI SEEDACTIVE MOIETY820LSF646I2
TARAXACUM OFFICINALE WHOLEACTIVE MOIETY7C42E2D7B02
TINACTIVE MOIETY387GMG9FH52
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
62106-112762106-1127-8
62106-113362106-1133-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
SARSAPARILLA2H1576D5WGACTIB
FILIPENDULA ULMARIA ROOT997724QNDSACTIB
ALUMINUMCPD4NFA903ACTIB
COPPER789U1901C5ACTIB
TIN387GMG9FH5ACTIB
WATER059QF0KO0RIACT
MARSDENIA CONDURANGO BARKR23QIR6YBAACTIB
ALCOHOL3K9958V90MIACT
TARAXACUM OFFICINALE WHOLE7C42E2D7B0ACTIB
LACTUCA VIROSA6D74QW4H67ACTIB
HOPS01G73H6H83ACTIB
JUNIPERUS COMMUNIS WHOLE464910T5N9ACTIB
EQUISETUM ARVENSE BRANCH1L0VKZ185EACTIB
GOLDENSEALZW3Z11D0JVACTIB
SYZYGIUM CUMINI SEED820LSF646IACTIB
GOLD79Y1949PYOACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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 28LACTUCA VIROSA, TARAXACUM OFFICINALE, SARSAPARILLA, SPIRAEA ULMARIA, CONDURANGO, ALUMINIUM METALLICUM, CUPRUM METALLICUM, STANNUM METALLICUMSeroyal USA182f4ad8-edf9-468c-e054-00144ff8d46c2022-11-09WarningsExact identifier
ndc (package): 62106-1127-8
ndc (package): 62106-1133-8
ndc (product): 62106-1127
ndc (product): 62106-1133
ndc11 (package): 62106112708
ndc11 (package): 62106113308
spl id: ed10726b-54cc-4ab6-e053-2a95a90afb86
spl set id: 182f4ad8-edf9-468c-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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