Bio Galium Phase

Product NDC
43742-1602
11-digit product format
437421602
Labeler code
43742
Product ID
43742-1602_5a1717ff-7c41-4f7b-ada7-45b5266f61fe
Type
HUMAN OTC DRUG
Nonproprietary name
Caltha Palustris, Clematis Erecta, Galium Aparine, Hedera Helix, Juniperus Communis, Sedum Acre, Sempervivum Tectorum, Thuja Occidentalis, Urtica Urens, Echinacea (Angustifolia), Argentum Metallicum, Calcarea Fluorica, Nitricum Acidum, Phosphorus, Cortisone Aceticum, Aurum Metallicum, Apis Mellifica, Ononis Spinosa, Gaertner Bacillus (Bach)
Dosage form
LIQUID
Route
ORAL
Labeler
Deseret Biologicals, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-10-30
Marketing end
2028-12-23
Substance
APIS MELLIFERA; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; CORTISONE ACETATE; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; GOLD; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; NITRIC ACID; ONONIS SPINOSA WHOLE; PHOSPHORUS; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS
Active strength
12; 8; 4; 4; 8; 5; 4; 10; 4; 4; 8; 5; 8; 30; 4; 4; 8; 4; 4 [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; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bio Galium Phase

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALTHA PALUSTRIS12 [hp_X]/mL
CLEMATIS RECTA FLOWERING TOP8 [hp_X]/mL
GALIUM APARINE4 [hp_X]/mL
HEDERA HELIX FLOWERING TWIG4 [hp_X]/mL
JUNIPER BERRY8 [hp_X]/mL
SEDUM ACRE5 [hp_X]/mL
SEMPERVIVUM TECTORUM LEAF4 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG10 [hp_X]/mL
URTICA URENS4 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA4 [hp_X]/mL
SILVER8 [hp_X]/mL
CALCIUM FLUORIDE5 [hp_C]/mL
NITRIC ACID8 [hp_X]/mL
PHOSPHORUS30 [hp_C]/mL
CORTISONE ACETATE4 [hp_X]/mL
GOLD4 [hp_X]/mL
APIS MELLIFERA8 [hp_X]/mL
ONONIS SPINOSA WHOLE4 [hp_X]/mL
SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS4 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 19 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6S9317F2UTInternal UNII lookup
396421SP9FInternal UNII lookup
Z4B6561488Internal UNII lookup
3D10KUA6BMInternal UNII lookup
O84B5194RLInternal UNII lookup
2496VW6S9JInternal UNII lookup
3DGJ7BUA01Internal UNII lookup
1NT28V9397Internal UNII lookup
IHN2NQ5OF9Internal UNII lookup
VB06AV5US8Internal UNII lookup
3M4G523W1GInternal UNII lookup
O3B55K4YKIInternal UNII lookup
411VRN1TV4Internal UNII lookup
27YLU75U4WInternal UNII lookup
883WKN7W8XInternal UNII lookup
79Y1949PYOInternal UNII lookup
7S82P3R43ZInternal UNII lookup
RP8496915MInternal UNII lookup
Y3V16D4PV4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1fcc1842-0ec7-4ec6-ac7f-6880ff5358c5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfd9c37-f773-6e9a-5f6b-6f5701d62adcProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43742-1602-1Bio Galium Phase30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43742-1602BIO GALIUM PHASE (CALTHA PALUSTRIS, CLEMATIS ERECTA, GALIUM APARINE, HEDERA HELIX, JUNIPERUS COMMUNIS, SEDUM ACRE, SEMPERVIVUM TECTORUM, THUJA OCCIDENTALIS, URTICA URENS, ECHINACEA (ANGUSTIFOLIA), ARGENTUM METALLICUM, CALCAREA FLUORICA, NITRICUM ACIDUM, PHOSPHORUS, CORTISONE ACETICUM, AURUM METALLICUM, APIS MELLIFICA, ONONIS SPINOSA, GAERTNER BACILLUS (BACH)) LIQUID [DESERET BIOLOGICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20240816_1fcc1842-0ec7-4ec6-ac7f-6880ff5358c5.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
Bio Galium PhaseCALTHA PALUSTRIS, CLEMATIS ERECTA, GALIUM APARINE, HEDERA HELIX, JUNIPERUS COMMUNIS, SEDUM ACRE, SEMPERVIVUM TECTORUM, THUJA OCCIDENTALIS, URTICA URENS, ECHINACEA (ANGUSTIFOLIA), ARGENTUM METALLICUM, CALCAREA FLUORICA, NITRICUM ACIDUM, PHOSPHORUS, CORTISONE ACETICUM, AURUM METALLICUM, APIS MELLIFICA, ONONIS SPINOSA, GAERTNER BACILLUS (BACH)Deseret Biologicals, Inc.1fcc1842-0ec7-4ec6-ac7f-6880ff5358c52024-08-15WarningsExact identifier
ndc (product): 43742-1602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43742-1602-14374216020130 mL in 1 BOTTLE, DROPPER (43742-1602-1) 30 ml2019-10-302028-12-23NoNoCurrent