MedPath

Heart Small Intestine Meridian Opener

DRUG FACTS:

Approved
Approval ID

5b693acf-acfd-42d9-b7ac-7c7b5923ed61

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.

Arsenicum Album, Aurum Metallicum, Belladonna, Cactus Grandiflorus, Cinchona Officinalis, Digitalis Purpurea, Kali Carbonicum, Lithium Carbonicum, Lycopodium Clavatum, Mercurius Solubilis, Naja Tripudians, Nux Vomica, Phosphorus, Pulsatilla (Pratensis), Pyrogenium, Spigelia Anthelmia

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43742-1573
Product Classification
G
Generic Name
Arsenicum Album, Aurum Metallicum, Belladonna, Cactus Grandiflorus, Cinchona Officinalis, Digitalis Purpurea, Kali Carbonicum, Lithium Carbonicum, Lycopodium Clavatum, Mercurius Solubilis, Naja Tripudians, Nux Vomica, Phosphorus, Pulsatilla (Pratensis), Pyrogenium, Spigelia Anthelmia
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (18)

ARSENIC TRIOXIDEActive
Quantity: 30 [hp_C] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
GOLDActive
Quantity: 30 [hp_C] in 1 mL
Code: 79Y1949PYO
Classification: ACTIB
ATROPA BELLADONNAActive
Quantity: 30 [hp_C] in 1 mL
Code: WQZ3G9PF0H
Classification: ACTIB
SELENICEREUS GRANDIFLORUS STEMActive
Quantity: 30 [hp_C] in 1 mL
Code: 7114SV0MYK
Classification: ACTIB
CINCHONA OFFICINALIS BARKActive
Quantity: 30 [hp_C] in 1 mL
Code: S003A158SB
Classification: ACTIB
DIGITALISActive
Quantity: 30 [hp_C] in 1 mL
Code: F1T8QT9U8B
Classification: ACTIB
POTASSIUM CARBONATEActive
Quantity: 30 [hp_C] in 1 mL
Code: BQN1B9B9HA
Classification: ACTIB
LITHIUM CARBONATEActive
Quantity: 30 [hp_C] in 1 mL
Code: 2BMD2GNA4V
Classification: ACTIB
LYCOPODIUM CLAVATUM SPOREActive
Quantity: 30 [hp_C] in 1 mL
Code: C88X29Y479
Classification: ACTIB
MERCURIUS SOLUBILISActive
Quantity: 30 [hp_C] in 1 mL
Code: 324Y4038G2
Classification: ACTIB
PHOSPHORUSActive
Quantity: 30 [hp_C] in 1 mL
Code: 27YLU75U4W
Classification: ACTIB
SPIGELIA ANTHELMIA WHOLEActive
Quantity: 30 [hp_C] in 1 mL
Code: WYT05213GE
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
NAJA NAJA VENOMActive
Quantity: 30 [hp_C] in 1 mL
Code: ZZ4AG7L7VM
Classification: ACTIB
STRYCHNOS NUX-VOMICA SEEDActive
Quantity: 30 [hp_C] in 1 mL
Code: 269XH13919
Classification: ACTIB
PULSATILLA PRATENSIS WHOLEActive
Quantity: 30 [hp_C] in 1 mL
Code: 8E272251DI
Classification: ACTIB
RANCID BEEFActive
Quantity: 30 [hp_C] in 1 mL
Code: 29SUH5R3HU
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/27/2024

PACKAGE LABEL DISPLAY:

Des****Bio

Heart Small Intestine

Meridian Opener

Homeopathic

NDC 43742-1573-1

1 FL OZ (30 ml)

Heart Small Intestine  Meridian Opener

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/27/2024

USES:

• For the temporary relief of symptoms including:

• tremor • night sweat • nausea • abdominal soreness

• sore bowels • flatus • belching • worse sight and smell of food

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: 3/27/2024

ACTIVE INGREDIENTS:

Arsenicum Album 30C, Aurum Metallicum 30C, Cactus Grandiflorus 30C, Cinchona Officinalis 30C, Digitalis Purpurea 30C, Kali Carbonicum 30C, Lithium Carbonicum 30C, Lycopodium Clavatum 30C, Mercurius Solubilis 30C, Naja Tripudians 30C, Nux Vomica 30C, Phosphorus 30C, Pulsatilla (Pratensis) 30C, Pyrogenium 30C, Spigelia Anthelmia 30C.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/27/2024

PURPOSE:

Arsenicum Album - Tremor, Aurum Metallicum – Night Sweat, Cactus Grandiflorus – Abdominal Soreness, Cinchona Officinalis – Worse Sight and Smell of Food, Digitalis Purpurea - Flatus, Kali Carbonicum - Nausea, Lithium Carbonicum – Sore Bowels, Lycopodium Clavatum - Belching, Mercurius Solubilis - Tremor, Naja Tripudians - Belching, Nux Vomica – Abdominal Soreness, Phosphorus – Sore Bowels, Pulsatilla (Pratensis) - Flatus, Pyrogenium – Abdominal Soreness, Spigelia Anthelmia - Nausea

WARNINGS SECTION

LOINC: 34071-1Updated: 3/27/2024

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.

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: 3/27/2024

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: 3/27/2024

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: 3/27/2024

INACTIVE INGREDIENTS:

Demineralized water, 25% ethanol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/27/2024

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.co

800-827-8204

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Heart Small Intestine Meridian Opener - FDA Drug Approval Details