Genstat

Product NDC
44911-0520
11-digit product format
449110520
Labeler code
44911
Product ID
44911-0520_aacaa774-0e0d-49da-85f0-023aeb49f339
Type
HUMAN OTC DRUG
Nonproprietary name
Aesculus Hippocastanum, Equisetum Hyemale, Fumaria Officinalis, Hydrocotyle Asiatica, Oleum Olea Europaea, Passiflora Incarnata, Ribes Nigrum, Solidago Virgaurea, Ononis Spinosa
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-10-25
Substance
CENTELLA ASIATICA WHOLE; EQUISETUM HYEMALE WHOLE; FUMARIA OFFICINALIS FLOWERING TOP; HORSE CHESTNUT; OLIVE OIL; ONONIS SPINOSA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; RIBES NIGRUM LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength
6; 6; 6; 6; 6; 14; 6; 7; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Lipid Emulsion [EPC], Lipids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HORSE CHESTNUT6 [hp_X]/mL
EQUISETUM HYEMALE WHOLE6 [hp_X]/mL
FUMARIA OFFICINALIS FLOWERING TOP6 [hp_X]/mL
CENTELLA ASIATICA WHOLE6 [hp_X]/mL
OLIVE OIL6 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP14 [hp_C]/mL
RIBES NIGRUM LEAF6 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP7 [hp_X]/mL
ONONIS SPINOSA WHOLE6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3C18L6RJAZInternal UNII lookup
59677RXH25Internal UNII lookup
VH659J61ZLInternal UNII lookup
7M867G6T1UInternal UNII lookup
6UYK2W1W1EInternal UNII lookup
CLF5YFS11OInternal UNII lookup
Z46FSZ2M25Internal UNII lookup
5405K23S50Internal UNII lookup
RP8496915MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
492f311e-f4b5-442d-adc3-d022e58b185eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-07-12Drug Facts:
2023-01-30Drug Facts:
2021-05-25Drug Facts:
2021-01-29Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0520-1Genstat120 mL in 1 BOTTLE, DROPPERLIQUID1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0520GENSTAT (AESCULUS HIPPOCASTANUM, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, HYDROCOTYLE ASIATICA, OLEUM OLEA EUROPAEA, PASSIFLORA INCARNATA, RIBES NIGRUM, SOLIDAGO VIRGAUREA, ONONIS SPINOSA) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20230713_492f311e-f4b5-442d-adc3-d022e58b185e.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
GenstatAESCULUS HIPPOCASTANUM, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, HYDROCOTYLE ASIATICA, OLEUM OLEA EUROPAEA, PASSIFLORA INCARNATA, RIBES NIGRUM, SOLIDAGO VIRGAUREA, ONONIS SPINOSAEnergique, Inc.492f311e-f4b5-442d-adc3-d022e58b185e2023-07-12WarningsExact identifier
ndc (product): 44911-0520

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0520-144911052001120 mL in 1 BOTTLE, DROPPER (44911-0520-1) 120 ml2019-10-250000-00-00NoNoCurrent