FDA.reportPublic FDA data

Unda 13

Manufacturer
Seroyal USA | SAN’UP
Effective date
2022-11-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:18:23

Label at a glance#

ProductUnda 13
Active ingredientSILVER, PEUMUS BOLDUS LEAF, RICINUS COMMUNIS SEED, COMBRETUM MICRANTHUM LEAF, JATEORHIZA CALUMBA ROOT
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Each drop contains:
Argentum metallicum (Silver) 12X
Boldo Leaf 4X

Combretum raimbaultii Leaf 4X
Jateorhiza palmata (Columbo) Root 4X
Ricinus communis (Castor bean) Seed 4X

OTC - PURPOSE SECTION

Uses
For the temporary relief of symptoms associated with digestive upset.

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

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 digestive upset.

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

62106-111262106-1112

NDC 62106-1112-8

UNDA

numbered compounds

UNDA 13

Homeopathic Preparation

For the temporary relief of symptoms
associated with digestive upset.

Contains 40% Alcohol
0.7 fl oz (20 mL)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1112-8Unda 131 in 1 BOXLIQUID16
62106-1112-8Unda 1320 mL in 1 BOTTLE, GLASSLIQUID206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1112UNDA 13 (BOLDO LEAF, RICINUS COMMUNIS SEED, COMBRETUM RAIMBAULTII LEAF, JATEORHIZA PALMATA ROOT, ARGENTUM METALLICUM) LIQUID [SEROYAL USA]6Current NDC, Legacy NDC, 2 package rows20221109_0a6be318-a469-385b-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
COMBRETUM MICRANTHUM LEAFACTIVE INGREDIENT8502S3Z5N11
JATEORHIZA CALUMBA ROOTACTIVE INGREDIENTV36I2B8LD51
PEUMUS BOLDUS LEAFACTIVE INGREDIENTQ4EWM09M3O1
RICINUS COMMUNIS SEEDACTIVE INGREDIENT7EK4SFN1TX1
SILVERACTIVE INGREDIENT3M4G523W1G1
COMBRETUM MICRANTHUM LEAFACTIVE MOIETY8502S3Z5N11
JATEORHIZA CALUMBA ROOTACTIVE MOIETYV36I2B8LD51
PEUMUS BOLDUS LEAFACTIVE MOIETYQ4EWM09M3O1
RICINUS COMMUNIS SEEDACTIVE MOIETY7EK4SFN1TX1
SILVERACTIVE MOIETY3M4G523W1G1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
62106-111262106-1112-8

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SILVER3M4G523W1GACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
PEUMUS BOLDUS LEAFQ4EWM09M3OACTIB
RICINUS COMMUNIS SEED7EK4SFN1TXACTIB
COMBRETUM MICRANTHUM LEAF8502S3Z5N1ACTIB
JATEORHIZA CALUMBA ROOTV36I2B8LD5ACTIB

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 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 13BOLDO LEAF, RICINUS COMMUNIS SEED, COMBRETUM RAIMBAULTII LEAF, JATEORHIZA PALMATA ROOT, ARGENTUM METALLICUMSeroyal USA0a6be318-a469-385b-e054-00144ff8d46c2022-11-08WarningsExact identifier
ndc (package): 62106-1112-8
ndc (product): 62106-1112
ndc11 (package): 62106111208
spl id: ecfac63b-c330-06d2-e053-2995a90aecba
spl set id: 0a6be318-a469-385b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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