FDA.reportPublic FDA data

UNDA 240

Product NDC
62106-1161
11-digit product format
621061161
Labeler code
62106
Product ID
62106-1161_ed11e5b0-cdb0-1f9a-e053-2995a90a0f16
Type
HUMAN OTC DRUG
Nonproprietary name
Equisetum arvense, Gentiana lutea, Salvia officinalis, Saxifraga granulata, Spiraea ulmaria
Dosage form
LIQUID
Route
ORAL
Labeler
Seroyal USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-12-14
Substance
FILIPENDULA ULMARIA ROOT; SAGE; GENTIANA LUTEA ROOT; SAXIFRAGA GRANULATA FLOWERING TOP; EQUISETUM ARVENSE BRANCH
Active strength
6; 6; 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
UNDA 240
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILIPENDULA ULMARIA ROOT6 [hp_X]/20mL
SAGE6 [hp_X]/20mL
GENTIANA LUTEA ROOT6 [hp_X]/20mL
SAXIFRAGA GRANULATA FLOWERING TOP6 [hp_X]/20mL
EQUISETUM ARVENSE BRANCH6 [hp_X]/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
997724QNDSInternal UNII lookup
065C5D077JInternal UNII lookup
S72O3284MSInternal UNII lookup
G5005J3X2BInternal UNII lookup
1L0VKZ185EInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43a3d9da-f7e9-2257-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1161-8UNDA 2401 in 1 CARTONLIQUID13
62106-1161-8UNDA 24020 mL in 1 BOTTLE, GLASSLIQUID203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1161UNDA 240 (EQUISETUM ARVENSE, GENTIANA LUTEA, SALVIA OFFICINALIS, SAXIFRAGA GRANULATA, SPIRAEA ULMARIA) LIQUID [SEROYAL USA]3Current NDC, Legacy NDC, 2 package rows20221110_43a3d9da-f7e9-2257-e054-00144ff8d46c.zip

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 240EQUISETUM ARVENSE, GENTIANA LUTEA, SALVIA OFFICINALIS, SAXIFRAGA GRANULATA, SPIRAEA ULMARIASeroyal USA43a3d9da-f7e9-2257-e054-00144ff8d46c2022-11-09WarningsExact identifier
ndc (product): 62106-1161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62106-1161-8621061161081 BOTTLE, GLASS in 1 CARTON (62106-1161-8) / 20 mL in 1 BOTTLE, GLASS2016-12-140000-00-00NoNoCurrent