FDA.reportPublic FDA data

UNDA 210

Product NDC
62106-1154
11-digit product format
621061154
Labeler code
62106
Product ID
62106-1154_c7335cbe-8359-b482-e053-2a95a90a24ac
Type
HUMAN OTC DRUG
Nonproprietary name
Boldo Leaf, Crataegus, Lactuca virosa, Passiflora incarnata, Valeriana officinalis
Dosage form
LIQUID
Route
ORAL
Labeler
Seroyal USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-09-22
Substance
CRATAEGUS FRUIT; LACTUCA VIROSA; PASSIFLORA INCARNATA FLOWERING TOP; PEUMUS BOLDUS LEAF; VALERIAN
Active strength
4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
UNDA 210
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CRATAEGUS FRUIT4 [hp_X]/20mL
LACTUCA VIROSA4 [hp_X]/20mL
PASSIFLORA INCARNATA FLOWERING TOP4 [hp_X]/20mL
PEUMUS BOLDUS LEAF4 [hp_X]/20mL
VALERIAN4 [hp_X]/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR0519OZO3K, 789U1901C5, 70FD1KFU70, Q4EWM09M3O, O3B55K4YKI, Q21UUL2105, 79Y1949PYO, JWF5YAW3QW, 6D74QW4H67, CLF5YFS11O

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
62106-1154-8UNDA 21020 mL in 1 BOTTLE, GLASSLIQUID206
62106-1154-8UNDA 2101 in 1 CARTONLIQUID16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKIUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
COPPERACTIVE INGREDIENT789U1901C5UNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
CRATAEGUS FRUITACTIVE INGREDIENTQ21UUL2105UNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
GELSEMIUM SEMPERVIRENS WHOLEACTIVE INGREDIENTR0519OZO3KUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
GOLDACTIVE INGREDIENT79Y1949PYOUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
LACTUCA VIROSAACTIVE INGREDIENT6D74QW4H67UNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11OUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
PEUMUS BOLDUS LEAFACTIVE INGREDIENTQ4EWM09M3OUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
SULFURACTIVE INGREDIENT70FD1KFU70UNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
VALERIANACTIVE INGREDIENTJWF5YAW3QWUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
COPPERACTIVE MOIETY789U1901C5UNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
CRATAEGUS FRUITACTIVE MOIETYQ21UUL2105UNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
GELSEMIUM SEMPERVIRENS WHOLEACTIVE MOIETYR0519OZO3KUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
GOLDACTIVE MOIETY79Y1949PYOUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
LACTUCA VIROSAACTIVE MOIETY6D74QW4H67UNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11OUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
PEUMUS BOLDUS LEAFACTIVE MOIETYQ4EWM09M3OUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
SULFURACTIVE MOIETY70FD1KFU70UNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
VALERIANACTIVE MOIETYJWF5YAW3QWUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2
WATERINACTIVE INGREDIENT059QF0KO0RUNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1154UNDA 210 (BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID UNDA 202 (AURUM METALLICUM, CALCAREA FLUORICA, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, SULPHUR) LIQUID [SEROYAL USA]6Current NDC, Legacy NDC, 2 package rows20210717_205b68ed-ff41-3559-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62106-1154-8621061154081 BOTTLE, GLASS in 1 CARTON (62106-1154-8) / 20 mL in 1 BOTTLE, GLASS2015-09-220000-00-00NoNoCurrent