MedPath

12 Male Reproductive

DRUG FACTS:

Approved
Approval ID

174077b1-c5af-49dc-aa24-f64adc2b94fa

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 28, 2025

Manufacturers
FDA

The Wellness Center

DUNS: 832363993

Products 1

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

Chimaphila Umbellata, Pituitaria Glandula (Suis), Sabal Serrulata, Uva-Ursi, Gelsemium Sempervirens, Sarsaparilla (Smilax Regelii)

PRODUCT DETAILS

NDC Product Code50181-0030
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateMay 28, 2025
Generic NameChimaphila Umbellata, Pituitaria Glandula (Suis), Sabal Serrulata, Uva-Ursi, Gelsemium Sempervirens, Sarsaparilla (Smilax Regelii)

INGREDIENTS (11)

CHIMAPHILA UMBELLATA WHOLEActive
Quantity: 3 [hp_X] in 1 mL
Code: WCK21A9W9J
Classification: ACTIB
SUS SCROFA PITUITARY GLAND, POSTERIORActive
Quantity: 3 [hp_C] in 1 mL
Code: E8S87O660T
Classification: ACTIB
SAW PALMETTOActive
Quantity: 6 [hp_C] in 1 mL
Code: J7WWH9M8QS
Classification: ACTIB
ARCTOSTAPHYLOS UVA-URSI LEAFActive
Quantity: 6 [hp_C] in 1 mL
Code: 3M5V3D1X36
Classification: ACTIB
SMILAX ORNATA ROOTActive
Quantity: 30 [hp_C] in 1 mL
Code: 2H1576D5WG
Classification: ACTIB
POTASSIUM PHOSPHATE, DIBASICActive
Quantity: 1 [hp_M] in 1 mL
Code: CI71S98N1Z
Classification: ACTIB
PHOSPHORIC ACIDActive
Quantity: 1 [hp_M] in 1 mL
Code: E4GA8884NN
Classification: ACTIB
ZINCActive
Quantity: 1 [hp_M] in 1 mL
Code: J41CSQ7QDS
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GELSEMIUM SEMPERVIRENS ROOTActive
Quantity: 30 [hp_C] in 1 mL
Code: 639KR60Q1Q
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/28/2025

PACKAGE DISPLAY LABEL:

Dr. Therese Dale's

NDC 50181-0030-1

HOMEOPATHIC

​N​euro-​E​motional​R​emedies

#12 MALE REPRODUCTIVE

1 fl oz (30 mL)

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INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/4/2013

INDICATIONS:

For the temporary relif of emotionlessness, denial, numbness, and unresponsiveness.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/4/2013

QUESTIONS:

MFD FOR:

The Wellness Center for Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

1-866-962-6484

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/4/2013

ACTIVE INGREDIENTS:

Chimaphila Umbellata 3X, Pituitaria Glandula (Suis) 3C, Sabal Serrulata 6C, Uva-Ursi 6C, Gelsemium Sempervirens 30C, Sarsaparilla (Smilax Regelii) 30C, Kali Phosphoricum 1M, Phosphoricum Acidum 1M, Zincum Metallicum 1M.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/4/2013

INDICATIONS:

For the temporary relif of emotionlessness, denial, numbness, and unresponsiveness.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/4/2013

WARNINGS:

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

**​Keep out of reach of children.**​ In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/4/2013

KEEP OUT OF REACH OF CHILDREN:

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/4/2013

DIRECTIONS:

Feel the emotion fully, breathe deeply-connecting breaths. Put 5 drops under tongue to release emotion. Continue 5 drops 2x daily as needed. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/4/2013

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

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12 Male Reproductive - FDA Drug Approval Details