MedPath

Immune Support

DRUG FACTS:

Approved
Approval ID

8906ed6e-3a64-47c2-bc41-ae5101aff69d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Deseret Biologicals, Inc.

DUNS: 940741853

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Aconitum Napellus, Argentum Nitricum, Arnica Montana, Arsenicum Album, Astragalus Membranaceus, Baptisia Tinctoria, Bryonia (Alba), Calendula Officinalis, Cortisone Aceticum, Echinacea (Angustifolia), Eupatorium Perfoliatum, Euphorbium Officinarum, Gelsemium Sempervirens, Hepar Sulphuris Calcareum, Influenzinum (2023-2024), Lachesis Mutus, Mercurius Corrosivus, Phosphorus, Phytolacca Decandra, Pulsatilla (Pratensis), Pyrogenium, Rhus Tox, Sanguinaria Canadensis, Spleen (Suis), Sulphur, Thuja Occidentalis,

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43742-2246
Product Classification
G
Generic Name
Aconitum Napellus, Argentum Nitricum, Arnica Montana, Arsenicum Album, Astragalus Membranaceus, Baptisia Tinctoria, Bryonia (Alba), Calendula Officinalis, Cortisone Aceticum, Echinacea (Angustifolia), Eupatorium Perfoliatum, Euphorbium Officinarum, Gelsemium Sempervirens, Hepar Sulphuris Calcareum, Influenzinum (2023-2024), Lachesis Mutus, Mercurius Corrosivus, Phosphorus, Phytolacca Decandra, Pulsatilla (Pratensis), Pyrogenium, Rhus Tox, Sanguinaria Canadensis, Spleen (Suis), Sulphur, Thuja Occidentalis,
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (34)

ACONITUM NAPELLUS WHOLEActive
Quantity: 8 [hp_X] in 1 mL
Code: U0NQ8555JD
Classification: ACTIB
SILVER NITRATEActive
Quantity: 8 [hp_X] in 1 mL
Code: 95IT3W8JZE
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 8 [hp_X] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
ASTRAGALUS MONGHOLICUS ROOTActive
Quantity: 12 [hp_X] in 1 mL
Code: 922OP8YUPF
Classification: ACTIB
BAPTISIA TINCTORIA ROOTActive
Quantity: 4 [hp_X] in 1 mL
Code: 5EF0HWI5WU
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 8 [hp_X] in 1 mL
Code: T7J046YI2B
Classification: ACTIB
CORTISONE ACETATEActive
Quantity: 13 [hp_X] in 1 mL
Code: 883WKN7W8X
Classification: ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOPActive
Quantity: 6 [hp_X] in 1 mL
Code: 1W0775VX6E
Classification: ACTIB
EUPHORBIA RESINIFERA RESINActive
Quantity: 6 [hp_X] in 1 mL
Code: 1TI1O9028K
Classification: ACTIB
CALCIUM SULFIDEActive
Quantity: 16 [hp_X] in 1 mL
Code: 1MBW07J51Q
Classification: ACTIB
INFLUENZA A VIRUS WHOLEActive
Quantity: 12 [hp_C] in 1 mL
Code: R9HH0NDE2E
Classification: ACTIB
INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) WHOLEActive
Quantity: 12 [hp_C] in 1 mL
Code: PMY5J4Z7LS
Classification: ACTIB
MERCURIC CHLORIDEActive
Quantity: 8 [hp_X] in 1 mL
Code: 53GH7MZT1R
Classification: ACTIB
PHOSPHORUSActive
Quantity: 8 [hp_X] in 1 mL
Code: 27YLU75U4W
Classification: ACTIB
TOXICODENDRON PUBESCENS LEAFActive
Quantity: 8 [hp_X] in 1 mL
Code: 6IO182RP7A
Classification: ACTIB
SANGUINARIA CANADENSIS ROOTActive
Quantity: 4 [hp_X] in 1 mL
Code: N9288CD508
Classification: ACTIB
SUS SCROFA SPLEENActive
Quantity: 12 [hp_X] in 1 mL
Code: 92AMN5J79Y
Classification: ACTIB
SULFURActive
Quantity: 8 [hp_X] in 1 mL
Code: 70FD1KFU70
Classification: ACTIB
THUJA OCCIDENTALIS LEAFY TWIGActive
Quantity: 8 [hp_X] in 1 mL
Code: 1NT28V9397
Classification: ACTIB
SUS SCROFA THYMUSActive
Quantity: 12 [hp_X] in 1 mL
Code: 7B69B0BD62
Classification: ACTIB
ZINCActive
Quantity: 10 [hp_X] in 1 mL
Code: J41CSQ7QDS
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ARNICA MONTANA WHOLEActive
Quantity: 4 [hp_X] in 1 mL
Code: O80TY208ZW
Classification: ACTIB
CALENDULA OFFICINALIS FLOWERING TOPActive
Quantity: 6 [hp_X] in 1 mL
Code: 18E7415PXQ
Classification: ACTIB
ECHINACEA ANGUSTIFOLIA WHOLEActive
Quantity: 1 [hp_X] in 1 mL
Code: VB06AV5US8
Classification: ACTIB
GELSEMIUM SEMPERVIRENS ROOTActive
Quantity: 8 [hp_X] in 1 mL
Code: 639KR60Q1Q
Classification: ACTIB
INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 WHOLEActive
Quantity: 12 [hp_C] in 1 mL
Code: CYK5P89K8X
Classification: ACTIB
INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B WHOLEActive
Quantity: 12 [hp_C] in 1 mL
Code: PS2DCE2WVF
Classification: ACTIB
LACHESIS MUTA VENOMActive
Quantity: 10 [hp_X] in 1 mL
Code: VSW71SS07I
Classification: ACTIB
PHYTOLACCA AMERICANA ROOTActive
Quantity: 8 [hp_X] in 1 mL
Code: 11E6VI8VEG
Classification: ACTIB
PULSATILLA PRATENSIS WHOLEActive
Quantity: 8 [hp_X] in 1 mL
Code: 8E272251DI
Classification: ACTIB
RANCID BEEFActive
Quantity: 200 [hp_X] in 1 mL
Code: 29SUH5R3HU
Classification: ACTIB
VISCUM ALBUM FRUITING TOPActive
Quantity: 12 [hp_X] in 1 mL
Code: BK9092J5MP
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/17/2025

PACKAGE LABEL DISPLAY:

DesBio

Immune Support

Homeopathic
NDC 43742-2246-1
1 FL OZ (30 ml)

Immune Support

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/17/2025

USES:

• For the temporary relief of symptoms including:

• cough • fever • headache • fatigue • coldness

• muscle pain • sore throat • ear congestion

• nose congestion • throat congestion

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/17/2025

ACTIVE INGREDIENTS:

Aconitum Napellus 8X, Argentum Nitricum 8X, Arnica Montana 4X, Arsenicum Album 8X, Astragalus Membranaceus 12X, Baptisia Tinctoria 4X, Bryonia (Alba) 8X, Calendula Officinalis 6X, Cortisone Aceticum 13X, Echinacea (Angustifolia) 1X, Eupatorium Perfoliatum 6X, Euphorbium Officinarum 6X, Gelsemium Sempervirens 8X, Hepar Sulphuris Calcareum 16X, Influenzinum 12C, Lachesis Mutus 10X, Mercurius Corrosivus 8X, Phosphorus 8X, Phytolacca Decandra 8X, Pulsatilla (Pratensis) 8X, Pyrogenium 200X, Rhus Tox 8X, Sanguinaria Canadensis 4X, Spleen (Suis) 12X, Sulphur 8X, Thuja Occidentalis 8X, Thymus (Suis) 12X, Viscum Album 12X, Zincum Metallicum 10X.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/17/2025

PURPOSE:

Aconitum Napellus - Cough, Argentum Nitricum - Fever, Arnica Montana - Headache, Arsenicum Album - Coldness, Astragalus Membranaceus – Muscle Pain, Baptisia Tinctoria – Sore Throat, Bryonia (Alba) – Ear Congestion, Calendula Officinalis – Muscle Pain, Cortisone Aceticum - Fatigue, Echinacea (Angustifolia) – Sore Throat, Eupatorium Perfoliatum - Cough, Euphorbium Officinarum - Fever, Gelsemium Sempervirens - Headache, Hepar Sulphuris Calcareum - Fatigue, Influenzinum - Coldness, Lachesis Mutus – Muscle Pain, Mercurius Corrosivus – Sore Throat, Phosphorus – Ear Congestion, Phytolacca Decandra – Nose Congestion, Pulsatilla (Pratensis) – Throat Congestion, Pyrogenium - Cough, Rhus Tox - Fatigue, Sanguinaria Canadensis - Fever, Spleen (Suis) - Fever, Sulphur – Nasal Congestion, Thuja Occidentalis – Coldness, Thymus (Suis) - Fever, Viscum Album – Sore Throat, Zincum Metallicum – Throat Congestion

WARNINGS SECTION

LOINC: 34071-1Updated: 1/17/2025

WARNINGS:

If pregnant or breastfeeding, ask a health professional before use.

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

Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/17/2025

KEEP OUT OF REACH OF CHILDREN:

In case of overdose, contact a physician or Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/17/2025

DIRECTIONS:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/17/2025

INACTIVE INGREDIENTS:

Demineralized water, 25% ethanol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/17/2025

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.
469 W. Parkland Drive
Sandy, UT 84070

www.desbio.com

800-827-8204

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Immune Support - FDA Drug Approval Details