FDA.reportPublic FDA data

UNDA 4

Manufacturer
Seroyal USA | SAN’UP
Effective date
2021-07-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:14:42

Label at a glance#

ProductUNDA 50
Active ingredientPEUMUS BOLDUS LEAF, SENNA LEAF, SILYBUM MARIANUM SEED, ACHILLEA MILLEFOLIUM, ALUMINUM, SILVER, FRANGULA ALNUS BARK, MENYANTHES TRIFOLIATA, WORMWOOD, JATEORHIZA CALUMBA ROOT, ANTIMONY TRISULFIDE, BAY LEAF, MARSDENIA CONDURANGO BARK
Label structure22 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Each drop contains:
Absinthium (Common wormwood) Aerial Parts 4X
Antimonium crudum (Antimonous sulfide) 12X
Argentum metallicum (Silver) 12X
Condurango Bark 4X
Jateorhiza palmata (Columbo) Root 4X
Laurus nobilis (Bay tree) Leaf 4X
Menyanthes trifoliata (Buckbean) Aerial Parts 4X
Rhamnus frangula (Buckthorn) Bark 4X

OTC - PURPOSE SECTION

Uses
For the temporary relief of symptoms associated with stomach
acidity, gas, belching and lack of appetite.

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 - STOP USE SECTION

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

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

For the temporary relief of symptoms associated with
stomach acidity, gas, belching and lack of appetite.

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
Argentum metallicum (Silver) 12X
Boldo Leaf 4X
Carduus marianus (Milk thistle) Fruit 4X
Millefolium (Yarrow) Aerial Parts 4X
Senna Leaf 4X

OTC - PURPOSE SECTION

Uses

For the temporary relief of symptoms
associated with poor digestion.

WARNINGS SECTION

Warnings

Stop use and ask a doctor if symptomspersist or worsen

If you are pregnant or breastfeeding, ask a healthcare practitioner 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 you are pregnant or breastfeeding, ask a healthcare practitioner 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

DOSAGE & ADMINISTRATION SECTION

Directions
Adults and Children (12 years and older)

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

Children (under 12 years)

Takeunder the direction of your healthcare practitioner.

INDICATIONS & USAGE SECTION

Uses
For the temporary relief of symptoms associated with poor digestion.

Directions
Adults and Children (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.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62106-1149-862106-1149-8

NDC 62106-1149-8

UNDA

numbered compounds

UNDA 50

Homeopathic Preparation

For the temporary relief of symptoms associated with poor digestion.

Contains 31% Alcohol
0.7 fl oz (20 ml)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62106-1103-862106-1103-8

NDC 62106-1103-8

UNDA

numbered compounds

UNDA 4

Homeopathic Preparation

For the temporary
relief of symptoms
associated with
stomach acidity, gas,
belching and lack
of appetite.

Contains 31% Alcohol
0.7 fl oz (20 ml)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1103-8UNDA 41 in 1 CARTONLIQUID17
62106-1103-8UNDA 420 mL in 1 BOTTLE, GLASSLIQUID207
62106-1149-8UNDA 5020 mL in 1 BOTTLE, GLASSLIQUID207
62106-1149-8UNDA 501 in 1 CARTONLIQUID17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1103UNDA 50 (BOLDO LEAF, SENNA LEAFLET, CARDUUS MARIANUS, MILLEFOLIUM, ALUMINIUM METALLICUM, ARGENTUM METALLICUM) LIQUID UNDA 4 (LAURUS NOBILIS, CONDURANGO, RHAMNUS FRANGULA, MENYANTHES TRIFOLIATA, ABSINTHIUM, JATEORHIZA PALMATA, ARGENTUM METALLICUM, ANTIMONIUM CRUDUM) LIQUID [SEROYAL USA]7Current NDC, Legacy NDC, 2 package rows20210716_1777c76b-5329-3c7b-e054-00144ff88e88.zip
62106-1149UNDA 50 (BOLDO LEAF, SENNA LEAFLET, CARDUUS MARIANUS, MILLEFOLIUM, ALUMINIUM METALLICUM, ARGENTUM METALLICUM) LIQUID UNDA 4 (LAURUS NOBILIS, CONDURANGO, RHAMNUS FRANGULA, MENYANTHES TRIFOLIATA, ABSINTHIUM, JATEORHIZA PALMATA, ARGENTUM METALLICUM, ANTIMONIUM CRUDUM) LIQUID [SEROYAL USA]7Current NDC, Legacy NDC, 2 package rows20210716_1777c76b-5329-3c7b-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACHILLEA MILLEFOLIUMACTIVE INGREDIENT2FXJ6SW4PK2
ALUMINUMACTIVE INGREDIENTCPD4NFA9032
ANTIMONY TRISULFIDEACTIVE INGREDIENTF79059A38U2
BAY LEAFACTIVE INGREDIENTWS0Y3M85RF2
FRANGULA ALNUS BARKACTIVE INGREDIENTS2D77IH61R2
JATEORHIZA CALUMBA ROOTACTIVE INGREDIENTV36I2B8LD52
MARSDENIA CONDURANGO BARKACTIVE INGREDIENTR23QIR6YBA2
MENYANTHES TRIFOLIATAACTIVE INGREDIENT7H0QTZ446K2
PEUMUS BOLDUS LEAFACTIVE INGREDIENTQ4EWM09M3O2
SENNA LEAFACTIVE INGREDIENTAK7JF626KX2
SILVERACTIVE INGREDIENT3M4G523W1G2
SILYBUM MARIANUM SEEDACTIVE INGREDIENTU946SH95EE2
WORMWOODACTIVE INGREDIENTF84709P2XV2
ACHILLEA MILLEFOLIUMACTIVE MOIETY2FXJ6SW4PK2
ALUMINUMACTIVE MOIETYCPD4NFA9032
ANTIMONY TRISULFIDEACTIVE MOIETYF79059A38U2
BAY LEAFACTIVE MOIETYWS0Y3M85RF2
FRANGULA ALNUS BARKACTIVE MOIETYS2D77IH61R2
JATEORHIZA CALUMBA ROOTACTIVE MOIETYV36I2B8LD52
MARSDENIA CONDURANGO BARKACTIVE MOIETYR23QIR6YBA2
MENYANTHES TRIFOLIATAACTIVE MOIETY7H0QTZ446K2
PEUMUS BOLDUS LEAFACTIVE MOIETYQ4EWM09M3O2
SENNA LEAFACTIVE MOIETYAK7JF626KX2
SILVERACTIVE MOIETY3M4G523W1G2
SILYBUM MARIANUM SEEDACTIVE MOIETYU946SH95EE2
WORMWOODACTIVE MOIETYF84709P2XV2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62106-110362106-1103-8
62106-114962106-1149-8

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
PEUMUS BOLDUS LEAFQ4EWM09M3OACTIB
SENNA LEAFAK7JF626KXACTIB
SILYBUM MARIANUM SEEDU946SH95EEACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
ALUMINUMCPD4NFA903ACTIB
SILVER3M4G523W1GACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
FRANGULA ALNUS BARKS2D77IH61RACTIB
MENYANTHES TRIFOLIATA7H0QTZ446KACTIB
WORMWOODF84709P2XVACTIB
JATEORHIZA CALUMBA ROOTV36I2B8LD5ACTIB
SILVER3M4G523W1GACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
BAY LEAFWS0Y3M85RFACTIB
MARSDENIA CONDURANGO BARKR23QIR6YBAACTIB

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 4LAURUS NOBILIS, CONDURANGO, RHAMNUS FRANGULA, MENYANTHES TRIFOLIATA, ABSINTHIUM, JATEORHIZA PALMATA, ARGENTUM METALLICUM, ANTIMONIUM CRUDUMSeroyal USA1777c76b-5329-3c7b-e054-00144ff88e882021-07-15WarningsExact identifier
ndc (package): 62106-1103-8
ndc (package): 62106-1149-8
ndc (product): 62106-1103
ndc (product): 62106-1149
ndc11 (package): 62106114908
ndc11 (package): 62106110308
spl id: c72e26cf-59a9-fae7-e053-2a95a90a6a00
spl set id: 1777c76b-5329-3c7b-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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