FDA.reportPublic FDA data

Unda 11

Manufacturer
Seroyal USA | SAN’UP
Effective date
2022-11-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:18:23

Label at a glance#

ProductUnda 11
Active ingredientVERBENA OFFICINALIS, COPPER, ASPARAGUS, GLECHOMA HEDERACEA, ARCTOSTAPHYLOS UVA-URSI LEAF, MENTHA PIPERITA, ACHILLEA MILLEFOLIUM, THYMUS SERPYLLUM, SAFFRON, ROSMARINUS OFFICINALIS FLOWERING TOP
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Each drop contains:
Asparagus officinalis (Asparagus) Shoot 4X
Crocus sativus (Saffron) Dried Stigma 4X
Cuprum metallicum (Copper) 12X
Glechoma hederacea (Ground-ivy) Aerial Parts 4X
Mentha piperita Aerial Parts 4X
Millefolium (Yarrow) Aerial Parts 4X
Rosmarinus officinalis (Rosemary) Leaf 4X
Thymus serpyllum (Wild thyme) Aerial Parts 4X
Uva-ursi (Bearberry) Leaf 4X
Verbena officinalis (Common vervain) Aerial Parts 4X

OTC - PURPOSE SECTION

Uses

For the temporary relief of minor pain
associated with

headaches

joints

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.

OTHER SAFETY INFORMATION

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

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 minor pain
associated with
headaches

joints

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

62106-111062106-1110

NDC 62106-1110-8

UNDA

numbered compounds

UNDA 11

Homeopathic Preparation

For the temporary relief of minor pain
associated with headaches and joints.

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1110-8Unda 1120 mL in 1 BOTTLE, GLASSLIQUID205
62106-1110-8Unda 111 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1110UNDA 11 (ASPARAGUS OFFICINALIS YOUNG SHOOT, MENTHA PIPERITA WHOLE PLANT, MILLEFOLIUM WHOLE PLANT,THYMUS SERPYLLUM WHOLE PLANT, CROCUS SATIVUS DRIED STIGMA, ROSMARINUS OFFICINALIS FLOWERING TWIGS, GLECHOMA HEDERACEA WHOLE PLANT, VERBENA OFFICINALIS WHOLE PLANT, UVA-URSI LEAF, CUPRUM METALLICUM) LIQUID [SEROYAL USA]5Current NDC, Legacy NDC, 2 package rows20221109_0fd85527-b04b-3f4a-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACHILLEA MILLEFOLIUMACTIVE INGREDIENT2FXJ6SW4PK1
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE INGREDIENT3M5V3D1X361
ASPARAGUSACTIVE INGREDIENTZ1EJP3037Z1
COPPERACTIVE INGREDIENT789U1901C51
GLECHOMA HEDERACEAACTIVE INGREDIENTL6O7WQK9121
MENTHA PIPERITAACTIVE INGREDIENT79M2M2UDA91
ROSMARINUS OFFICINALIS FLOWERING TOPACTIVE INGREDIENT8JM482TI791
SAFFRONACTIVE INGREDIENTE849G4X5YJ1
THYMUS SERPYLLUMACTIVE INGREDIENT86H4S6K51N1
VERBENA OFFICINALISACTIVE INGREDIENTQT8A71T9BM1
ACHILLEA MILLEFOLIUMACTIVE MOIETY2FXJ6SW4PK1
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE MOIETY3M5V3D1X361
ASPARAGUSACTIVE MOIETYZ1EJP3037Z1
COPPERACTIVE MOIETY789U1901C51
GLECHOMA HEDERACEAACTIVE MOIETYL6O7WQK9121
MENTHA PIPERITAACTIVE MOIETY79M2M2UDA91
ROSMARINUS OFFICINALIS FLOWERING TOPACTIVE MOIETY8JM482TI791
SAFFRONACTIVE MOIETYE849G4X5YJ1
THYMUS SERPYLLUMACTIVE MOIETY86H4S6K51N1
VERBENA OFFICINALISACTIVE MOIETYQT8A71T9BM1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62106-111062106-1110-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
VERBENA OFFICINALISQT8A71T9BMACTIB
COPPER789U1901C5ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ASPARAGUSZ1EJP3037ZACTIB
GLECHOMA HEDERACEAL6O7WQK912ACTIB
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36ACTIB
MENTHA PIPERITA79M2M2UDA9ACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
THYMUS SERPYLLUM86H4S6K51NACTIB
SAFFRONE849G4X5YJACTIB
ROSMARINUS OFFICINALIS FLOWERING TOP8JM482TI79ACTIB

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 11ASPARAGUS OFFICINALIS YOUNG SHOOT, MENTHA PIPERITA WHOLE PLANT, MILLEFOLIUM WHOLE PLANT,THYMUS SERPYLLUM WHOLE PLANT, CROCUS SATIVUS DRIED STIGMA, ROSMARINUS OFFICINALIS FLOWERING TWIGS, GLECHOMA HEDERACEA WHOLE PLANT, VERBENA OFFICINALIS WHOLE PLANT, UVA-URSI LEAF, CUPRUM METALLICUMSeroyal USA0fd85527-b04b-3f4a-e054-00144ff8d46c2022-11-08WarningsExact identifier
ndc (package): 62106-1110-8
ndc (product): 62106-1110
ndc11 (package): 62106111008
spl id: ecfa9109-e935-ad4e-e053-2a95a90a372b
spl set id: 0fd85527-b04b-3f4a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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