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DRUG FACTS:

Approved
Approval ID

284327cc-2d06-4f75-a296-52c34f149693

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.

Argentum Nitricum, Aspergillus Niger, Candida Albicans, Euphorbium Officinarum, Gallicum Acidum, Hepar Sulphuris Calcareum, Influenzinum (2023-2024), Luffa Operculata, Mercurius Iodatus Ruber, Mucor Racemosus, Mutabile Bacillus (Bach), Pulsatilla (Pratensis), Sinusitisinum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43742-2142
Product Classification
G
Generic Name
Argentum Nitricum, Aspergillus Niger, Candida Albicans, Euphorbium Officinarum, Gallicum Acidum, Hepar Sulphuris Calcareum, Influenzinum (2023-2024), Luffa Operculata, Mercurius Iodatus Ruber, Mucor Racemosus, Mutabile Bacillus (Bach), Pulsatilla (Pratensis), Sinusitisinum
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (18)

SILVER NITRATEActive
Quantity: 10 [hp_X] in 1 mL
Code: 95IT3W8JZE
Classification: ACTIB
ASPERGILLUS NIGER VAR. NIGERActive
Quantity: 10 [hp_C] in 1 mL
Code: 9IOA40ANG6
Classification: ACTIB
CANDIDA ALBICANSActive
Quantity: 10 [hp_C] in 1 mL
Code: 4D7G21HDBC
Classification: ACTIB
EUPHORBIA RESINIFERA RESINActive
Quantity: 6 [hp_X] in 1 mL
Code: 1TI1O9028K
Classification: ACTIB
GALLIC ACID MONOHYDRATEActive
Quantity: 10 [hp_C] in 1 mL
Code: 48339473OT
Classification: ACTIB
CALCIUM SULFIDEActive
Quantity: 10 [hp_X] in 1 mL
Code: 1MBW07J51Q
Classification: ACTIB
INFLUENZA A VIRUS WHOLEActive
Quantity: 12 [hp_C] in 1 mL
Code: R9HH0NDE2E
Classification: ACTIM
INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) WHOLEActive
Quantity: 12 [hp_C] in 1 mL
Code: PMY5J4Z7LS
Classification: ACTIB
LUFFA OPERCULATA FRUITActive
Quantity: 6 [hp_X] in 1 mL
Code: C4MO6809HU
Classification: ACTIB
MERCURIC IODIDEActive
Quantity: 8 [hp_X] in 1 mL
Code: R03O05RB0P
Classification: ACTIB
MUCOR RACEMOSUSActive
Quantity: 10 [hp_C] in 1 mL
Code: 17RH99LQ7G
Classification: ACTIB
ESCHERICHIA COLIActive
Quantity: 30 [hp_C] in 1 mL
Code: 514B9K0L10
Classification: ACTIB
SINUSITISINUMActive
Quantity: 17 [hp_X] in 1 mL
Code: B575563DM5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B WHOLEActive
Quantity: 12 [hp_C] in 1 mL
Code: PS2DCE2WVF
Classification: ACTIB
INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 WHOLEActive
Quantity: 12 [hp_C] in 1 mL
Code: CYK5P89K8X
Classification: ACTIB
PULSATILLA PRATENSIS WHOLEActive
Quantity: 4 [hp_X] in 1 mL
Code: 8E272251DI
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/13/2024

PACKAGE LABEL DISPLAY:

DesBio

ENT Support

Homeopathic

NDC 43742-2142-1

1 FL OZ (30ml)

ENT Support

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/13/2024

USES:

• For the temporary relief of symptoms including:

• ear pain • sinus pain • throat pain • sinus congestion

• nasal congestion • cough • ear mucus • sneezing

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: 3/13/2024

ACTIVE INGREDIENTS:

Argentum Nitricum 10X, Aspergillus Niger 10C, 15C, 30C, 200C, Candida Albicans 10C, 15C, 30C, 200C, Euphorbium Officinarum 6X, Gallicum Acidum 10C, 15C, 30C, 200C, Hepar Sulphuris Calcareum 10X, Influenzinum 12C, Luffa Operculata 6X, Mercurius Iodatus Ruber 8X, Mucor Racemosus 10C, 15C, 30C, 200C, Mutabile Bacillus (Bach) 30C, Pulsatilla (Pratensis) 4X, Sinusitisinum 17X.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/13/2024

PURPOSE:

Argentum Nitricum – Ear Pain, Aspergillus Niger – Sinus Pain, Candida Albicans – Throat Pain, Euphorbium Officinarum – Sinus Congestion, Gallicum Acidum - Cough, Hepar Sulphuris Calcareum – Nasal Congestion, Influenzinum - Sneezing, Luffa Operculata – Ear Mucus, Mercurius Iodatus Ruber – Sinus Pain, Mucor Racemosus – Sinus Congestion, Mutabile Bacillus (Bach) – Nasal Congestion, Pulsatilla (Pratensis) – Sinus Congestion, Sinusitisinum – Nasal Congestion

WARNINGS SECTION

LOINC: 34071-1Updated: 3/13/2024

WARNINGS:

**If pregnant or breast-feeding,**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.

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.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 3/13/2024

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: 3/13/2024

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: 3/13/2024

INACTIVE INGREDIENTS:

Demineralized water, 25% ethanol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/13/2024

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.com

800-827-8204

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ENT Support - FDA Drug Approval Details