FDA.reportPublic FDA data

Bio Galium Phase

Manufacturer
Deseret Biologicals, Inc. | Apotheca Company
Effective date
2024-08-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:27:46

Label at a glance#

ProductBio Galium Phase
Active ingredientCALTHA PALUSTRIS, CLEMATIS RECTA FLOWERING TOP, GALIUM APARINE, HEDERA HELIX FLOWERING TWIG, JUNIPER BERRY, SEDUM ACRE, SEMPERVIVUM TECTORUM LEAF, THUJA OCCIDENTALIS LEAFY TWIG, URTICA URENS, ECHINACEA ANGUSTIFOLIA, SILVER, CALCIUM FLUORIDE, NITRIC ACID, PHOSPHORUS, CORTISONE ACETATE, GOLD, APIS MELLIFERA, ONONIS SPINOSA WHOLE, SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS
Label structure9 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Caltha Palustris 4X, Clematis Erecta 4X, Galium Aparine 4X, Hedera Helix 4X, Juniperus Communis 4X, Sedum Acre 4X, Sempervivum Tectorum 4X, Thuja Occidentalis 4X, Urtica Urens 4X, Echinacea (Angustifolia) 5X, Argentum Metallicum 8X, Calcarea Fluorica 8X, Nitricum Acidum 8X, Phosphorus 8X, Cortisone Aceticum 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Aurum Metallicum 10X, Apis Mellifica 12X, Ononis Spinosa 5C, Gaertner Bacillus (Bach) 30C.

HOMEOPATHIC INDICATIONS:

OTC - PURPOSE SECTION

For the temporary relief of symptoms related to illness and infections such as cold and flu.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

DIRECTONS:

DOSAGE & ADMINISTRATION SECTION

1-10 drops under the tongue, 2 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

HOMEOPATHIC INDICATIONS:

INDICATIONS & USAGE SECTION

For the temporary relief of symptoms related to illness and infections such as cold and flu.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DESBIO

NDC 43742-1602-1

HOMEOPATHIC

BIO GALIUM

PHASE

1 FL OZ (30 ml)

Bio Galium PhaseBio Galium Phase

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43742-160243742-1602-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALTHA PALUSTRIS6S9317F2UTACTIB
CLEMATIS RECTA FLOWERING TOP396421SP9FACTIB
GALIUM APARINEZ4B6561488ACTIB
HEDERA HELIX FLOWERING TWIG3D10KUA6BMACTIB
JUNIPER BERRYO84B5194RLACTIB
SEDUM ACRE2496VW6S9JACTIB
SEMPERVIVUM TECTORUM LEAF3DGJ7BUA01ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
URTICA URENSIHN2NQ5OF9ACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
SILVER3M4G523W1GACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
NITRIC ACID411VRN1TV4ACTIB
PHOSPHORUS27YLU75U4WACTIB
CORTISONE ACETATE883WKN7W8XACTIB
GOLD79Y1949PYOACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ONONIS SPINOSA WHOLERP8496915MACTIB
SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDISY3V16D4PV4ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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 (package): 43742-1602-1
ndc (product): 43742-1602
ndc11 (package): 43742160201
spl id: 5a1717ff-7c41-4f7b-ada7-45b5266f61fe
spl set id: 1fcc1842-0ec7-4ec6-ac7f-6880ff5358c5

Reported adverse events (FAERS/openFDA)#

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