FDA.reportPublic FDA data

B HP

Product NDC
44911-0620
11-digit product format
449110620
Labeler code
44911
Product ID
44911-0620_dff4cf54-e2fd-4103-b111-36406fcd5de6
Type
HUMAN OTC DRUG
Nonproprietary name
Apis Mellifica, Arsenicum Album, Belladonna, Chamomilla, Echinacea (Angustifolia), Lachesis Mutus, Mercurius Solubilis, Pulsatilla (Vulgaris), Pyrogenium, Rhus Tox, Silicea
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-04-15
Marketing end
2027-06-15
Substance
APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA WHOLE; LACHESIS MUTA VENOM; MATRICARIA CHAMOMILLA WHOLE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS WHOLE; RANCID BEEF; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF
Active strength
30; 30; 30; 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; [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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
B HP

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA30 [hp_X]/mL
ARSENIC TRIOXIDE30 [hp_X]/mL
ATROPA BELLADONNA30 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE30 [hp_X]/mL
LACHESIS MUTA VENOM30 [hp_X]/mL
MATRICARIA CHAMOMILLA WHOLE30 [hp_X]/mL
MERCURIUS SOLUBILIS30 [hp_X]/mL
PULSATILLA VULGARIS WHOLE30 [hp_X]/mL
RANCID BEEF30 [hp_X]/mL
SILICON DIOXIDE30 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S82P3R43Z, S7V92P67HO, WQZ3G9PF0H, VB06AV5US8, VSW71SS07I, G0R4UBI2ZZ, 324Y4038G2, I76KB35JEV, 29SUH5R3HU, ETJ7Z6XBU4, 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
44911-0620-12024-05-08C16284748780-1f386c64a-26a5-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0620-12023-01-30C16284748780-1f386c64a-26a5-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0620-1B HP60 mL in 1 BOTTLE, DROPPERLIQUID603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0620B HP (APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEA) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240509_a1b42f4b-4029-4008-b950-a7725f34b43d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0620-14491106200160 mL in 1 BOTTLE, DROPPER (44911-0620-1) 60 ml2021-04-152027-06-15NoNoCurrent