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FDA Approval

MYCCombination

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Deseret Biologicals, Inc.
DUNS: 940741853
Effective Date
May 27, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Onion(6 [hp_X] in 1 mL)
Sodium sulfate(6 [hp_X] in 1 mL)
Potassium carbonate(8 [hp_X] in 1 mL)
sanguinaria canadensis root(8 [hp_X] in 1 mL)
amanita muscaria fruiting body(12 [hp_X] in 1 mL)
Antimony potassium tartrate(12 [hp_X] in 1 mL)
arsenic triiodide(12 [hp_X] in 1 mL)
Phenol(12 [hp_X] in 1 mL)
cinchona officinalis bark(12 [hp_X] in 1 mL)
Iron(12 [hp_X] in 1 mL)
Sulfuric acid(12 [hp_X] in 1 mL)
thuja occidentalis leafy twig(12 [hp_X] in 1 mL)
Ammonium carbonate(12 [hp_X] in 1 mL)
Aspergillus niger var. niger(15 [hp_X] in 1 mL)
blatta orientalis(9 [hp_C] in 1 mL)
mephitis mephitis anal gland fluid(12 [hp_C] in 1 mL)
Purple pitcher plant(12 [hp_X] in 1 mL)
Echinacea angustifolia root(6 [hp_X] in 1 mL)
Phytolacca americana Extract(12 [hp_X] in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Apotheca Company

844330915

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Apotheca Company

Deseret Biologicals, Inc.

Apotheca Company

844330915

Products1

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

MYCCombination

Product Details

NDC Product Code
43742-2108
Route of Administration
ORAL
Effective Date
May 27, 2025
OnionActive
Code: 492225Q21HClass: ACTIBQuantity: 6 [hp_X] in 1 mL
Sodium sulfateActive
Code: 0YPR65R21JClass: ACTIBQuantity: 6 [hp_X] in 1 mL
Potassium carbonateActive
Code: BQN1B9B9HAClass: ACTIBQuantity: 8 [hp_X] in 1 mL
sanguinaria canadensis rootActive
Code: N9288CD508Class: ACTIBQuantity: 8 [hp_X] in 1 mL
amanita muscaria fruiting bodyActive
Code: DIF093I037Class: ACTIBQuantity: 12 [hp_X] in 1 mL
Antimony potassium tartrateActive
Code: DL6OZ476V3Class: ACTIBQuantity: 12 [hp_X] in 1 mL
arsenic triiodideActive
Code: 3029988O2TClass: ACTIMQuantity: 12 [hp_X] in 1 mL
PhenolActive
Code: 339NCG44TVClass: ACTIBQuantity: 12 [hp_X] in 1 mL
cinchona officinalis barkActive
Code: S003A158SBClass: ACTIBQuantity: 12 [hp_X] in 1 mL
IronActive
Code: E1UOL152H7Class: ACTIBQuantity: 12 [hp_X] in 1 mL
Sulfuric acidActive
Code: O40UQP6WCFClass: ACTIBQuantity: 12 [hp_X] in 1 mL
thuja occidentalis leafy twigActive
Code: 1NT28V9397Class: ACTIBQuantity: 12 [hp_X] in 1 mL
Ammonium carbonateActive
Code: NJ5VT0FKLJClass: ACTIBQuantity: 12 [hp_X] in 1 mL
Aspergillus niger var. nigerActive
Code: 9IOA40ANG6Class: ACTIBQuantity: 15 [hp_X] in 1 mL
blatta orientalisActive
Code: 535787266DClass: ACTIBQuantity: 9 [hp_C] in 1 mL
mephitis mephitis anal gland fluidActive
Code: 3BN57UN4USClass: ACTIBQuantity: 12 [hp_C] in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
Purple pitcher plantActive
Code: 01G9XEA93NClass: ACTIBQuantity: 12 [hp_X] in 1 mL
Echinacea angustifolia rootActive
Code: VB06AV5US8Class: ACTIBQuantity: 6 [hp_X] in 1 mL
Phytolacca americana ExtractActive
Code: 11E6VI8VEGClass: ACTIBQuantity: 12 [hp_X] in 1 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL DISPLAY:

DesBio

MYC: Combination

Homeopathic
NDC 43742-2108-1
1 FL OZ (30 ml)

MYC: Combination

INDICATIONS & USAGE SECTION

USES:

• For the temporary relief of symptoms including:

• wheezing • cough • burning throat

• headache • fatigue • joint pain

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

DOSAGE & ADMINISTRATION SECTION

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.

WARNINGS SECTION

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 - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

Agaricus Muscarius 12X, Allium Cepa 6X, Ammonium Carbonicum 12X, 24X, 30X, Antimonium Tartaricum 12X, Arsenicum Iodatum 12X, Aspergillus Niger 15X, 30X, 60X, 100X, 200X, Blatta Orientalis 9C, 12C, 30C, Carbolicum Acidum 12X, Cinchona Officinalis 12X, Echinacea (Angustifolia) 6X, Ferrum Metallicum 12X, Kali Carbonicum 8X, Mephitis Mephitica 12C, Natrum Sulphuricum 6X, 12X, 30X, Phytolacca Decandra 12X, Sanguinaria Canadensis 8X, Secale Cornutum 12X, Sulphuricum Acidum 12X, Thuja Occidentalis 12X.

OTC - PURPOSE SECTION

PURPOSE:

Agaricus Muscarius - Wheezing, Allium Cepa - Cough, Ammonium Carbonicum – Burning Throat, Antimonium Tartaricum - Headache, Arsenicum Iodatum - Fatigue, Aspergillus Niger - Fatigue, Blatta Orientalis - Cough, Carbolicum Acidum - Wheezing, Cinchona Officinalis – Burning Throat, Echinacea (Angustifolia) - Headache, Ferrum Metallicum – Joint Pain, Kali Carbonicum – Joint Pain, Mephitis Mephitica - Cough, Natrum Sulphuricum - Wheezing, Phytolacca Decandra – Burning Throat, Sanguinaria Canadensis - Headache, Secale Cornutum - Fatigue, Sulphuricum Acidum – Joint Pain, Thuja Occidentalis - Cough

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.

OTC - QUESTIONS SECTION

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.com

800-827-8204

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

Demineralized water, 25% ethanol

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