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12 Male Reproductive

12 Male Reproductive

Approved
Approval ID

e888278a-e7ef-4b42-b0b7-63afaff45b1c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 10, 2025

Manufacturers
FDA

Apotheca Company

DUNS: 844330915

Products 1

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

Chimaphila umbellata, Pituitary, Sabal serrulata, Uva-ursi, Gelsemium sempervirens, Sarsaparilla, Kali phosphoricum, Phosphoricum acidum, Zincum metallicum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57520-0494
Product Classification
G
Generic Name
Chimaphila umbellata, Pituitary, Sabal serrulata, Uva-ursi, Gelsemium sempervirens, Sarsaparilla, Kali phosphoricum, Phosphoricum acidum, Zincum metallicum
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2025
FDA Product Classification

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
GELSEMIUM SEMPERVIRENS ROOTActive
Quantity: 30 [hp_C] in 1 mL
Code: 639KR60Q1Q
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ZINCActive
Quantity: 1 [hp_M] in 1 mL
Code: J41CSQ7QDS
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/9/2025

Dr. Theresa Dale's

Homeopathic

Neuro0Emotional Remedies

#12 MALE REPRODUCTIVE PITUITARY/TESTES/PROSTATE

Unresponsive

1 fl oz (30 ml)

12 Male Reproductive

12 Male Reproductive

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/9/2025

INDICATIONS:

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/18/2010

ACTIVE INGREDIENTS: Chimaphila umbellata 3X, Pituitary 3C, Sabal serrulata 6C, Uva-ursi 6C, Gelsemium sempervirens 30C, Sarsaparilla 30C, Kali phosphoricum 1M, Phosphoricum acidum 1M, Zincum metallicum 1M.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/9/2025

INDICATIONS: For the temporary relief of emotionlessness, denial, numbness and unresponsiveness.

WARNINGS SECTION

LOINC: 34071-1Updated: 6/9/2025

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: 6/9/2025

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: 6/18/2010

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: 6/9/2025

INACTIVE INGREDIENTS:

Demineralized water, 25% Alcohol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/18/2010

MFG. FOR:

Theresa Dale, N.D.

1237 S. Victoria Ave.

Oxnard, CA 93035

1-868-962-6484

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12 Male Reproductive - FDA Drug Approval Details