FDA.reportPublic FDA data

Edema

Product NDC
44911-0244
11-digit product format
449110244
Labeler code
44911
Product ID
44911-0244_17afcc81-d97c-4321-b373-0d2561827269
Type
HUMAN OTC DRUG
Nonproprietary name
Apis Mellifica, Apocynum Cannabinum, Arsenicum Album, Digitalis Purpurea, Lycopodium Clavatum, Rhus Tox, Sambucus Nigra, Strophanthus Hispidus
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-08-24
Substance
APIS MELLIFERA; APOCYNUM CANNABINUM ROOT; ARSENIC TRIOXIDE; DIGITALIS; LYCOPODIUM CLAVATUM SPORE; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; TOXICODENDRON PUBESCENS LEAF
Active strength
30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Edema
Brand name suffix
HP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA30 [hp_X]/mL
APOCYNUM CANNABINUM ROOT30 [hp_X]/mL
ARSENIC TRIOXIDE30 [hp_X]/mL
DIGITALIS30 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE30 [hp_X]/mL
SAMBUCUS NIGRA FLOWERING TOP30 [hp_X]/mL
STROPHANTHUS HISPIDUS SEED30 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S82P3R43Z, 2F92409L9Z, S7V92P67HO, F1T8QT9U8B, C88X29Y479, CT03BSA18U, MO892VI77K, 6IO182RP7A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0244-12024-10-24C16284748780-11030e365-0b8d-111a-e063-dadaa90a10e2DRUG FACTS:
44911-0244-12024-01-30C16284748780-11030e365-0b8d-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0244-1EdemaHP30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43ZEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
APOCYNUM CANNABINUM ROOTACTIVE INGREDIENT2F92409L9ZEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HOEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
DIGITALISACTIVE INGREDIENTF1T8QT9U8BEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y479EDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
SAMBUCUS NIGRA FLOWERING TOPACTIVE INGREDIENTCT03BSA18UEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
STROPHANTHUS HISPIDUS SEEDACTIVE INGREDIENTMO892VI77KEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7AEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
APIS MELLIFERAACTIVE MOIETY7S82P3R43ZEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
APOCYNUM CANNABINUM ROOTACTIVE MOIETY2F92409L9ZEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AVEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
DIGITALISACTIVE MOIETYF1T8QT9U8BEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y479EDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
SAMBUCUS NIGRA FLOWERING TOPACTIVE MOIETYCT03BSA18UEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
STROPHANTHUS HISPIDUS SEEDACTIVE MOIETYMO892VI77KEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7AEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MEDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0REDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0244EDEMA HP (APIS MELLIFICA, APOCYNUM CANNABINUM, ARSENICUM ALBUM, DIGITALIS PURPUREA, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [ENERGIQUE, INC.]4Current NDC, Legacy NDC, 1 package rows20241027_87cb554e-3961-449a-a4af-a572662477b2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0244-14491102440130 mL in 1 BOTTLE, DROPPER (44911-0244-1) 30 ml2015-08-240000-00-00NoNoCurrent