12 Male Reproductive

Manufacturer: Apotheca Company
Effective date: 2025-06-10
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 20:37:05

Label at a glance#

Product12 Male Reproductive

Active ingredientCHIMAPHILA UMBELLATA WHOLE, SUS SCROFA PITUITARY GLAND, POSTERIOR, SAW PALMETTO, ARCTOSTAPHYLOS UVA-URSI LEAF, GELSEMIUM SEMPERVIRENS ROOT, SMILAX ORNATA ROOT, POTASSIUM PHOSPHATE, DIBASIC, PHOSPHORIC ACID, ZINC

Label structure9 sections

Contacts and useful links#

PhoneLabel contact1-868-962-6484

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

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

WARNINGS SECTION

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.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 25% Alcohol

OTC - QUESTIONS SECTION

MFG. FOR:

Theresa Dale, N.D.

1237 S. Victoria Ave.

Oxnard, CA 93035

1-868-962-6484

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Theresa Dale's

Homeopathic

Neuro0Emotional Remedies

#12 MALE REPRODUCTIVE PITUITARY/TESTES/PROSTATE

Unresponsive

1 fl oz (30 ml)

12 Male Reproductive

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57520-0494-1	2025-06-10	C162847	48780-1	9d75b9d0-2a25-f424-e053-dadaa90a57ce	12 Male Reproductive
57520-0494-1	2020-01-31	C162847	48780-1	9d75b9d0-2a25-f424-e053-dadaa90a57ce	12 Male Reproductive

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ARCTOSTAPHYLOS UVA-URSI LEAF	ACTIVE INGREDIENT	3M5V3D1X36	1
CHIMAPHILA UMBELLATA	ACTIVE INGREDIENT	WCK21A9W9J	1
GELSEMIUM SEMPERVIRENS ROOT	ACTIVE INGREDIENT	639KR60Q1Q	1
PHOSPHORIC ACID	ACTIVE INGREDIENT	E4GA8884NN	1
POTASSIUM PHOSPHATE, DIBASIC	ACTIVE INGREDIENT	CI71S98N1Z	1
SARSAPARILLA	ACTIVE INGREDIENT	2H1576D5WG	1
SAW PALMETTO	ACTIVE INGREDIENT	J7WWH9M8QS	1
SUS SCROFA PITUITARY GLAND	ACTIVE INGREDIENT	E8S87O660T	1
ZINC	ACTIVE INGREDIENT	J41CSQ7QDS	1
ARCTOSTAPHYLOS UVA-URSI LEAF	ACTIVE MOIETY	3M5V3D1X36	1
CHIMAPHILA UMBELLATA	ACTIVE MOIETY	WCK21A9W9J	1
GELSEMIUM SEMPERVIRENS ROOT	ACTIVE MOIETY	639KR60Q1Q	1
PHOSPHORIC ACID	ACTIVE MOIETY	E4GA8884NN	1
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	1
SARSAPARILLA	ACTIVE MOIETY	2H1576D5WG	1
SAW PALMETTO	ACTIVE MOIETY	J7WWH9M8QS	1
SUS SCROFA PITUITARY GLAND	ACTIVE MOIETY	E8S87O660T	1
ZINC	ACTIVE MOIETY	J41CSQ7QDS	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

12 Male Reproductive
Chimaphila umbellata, Pituitary, Sabal serrulata, Uva-ursi, Gelsemium sempervirens, Sarsaparilla, Kali phosphoricum, Phosphoricum acidum, Zincum metallicum
CHIMAPHILA UMBELLATA WHOLE
CHIMAPHILA UMBELLATA
SUS SCROFA PITUITARY GLAND, POSTERIOR
SAW PALMETTO
ARCTOSTAPHYLOS UVA-URSI LEAF
GELSEMIUM SEMPERVIRENS ROOT
SMILAX ORNATA ROOT
SARSAPARILLA
POTASSIUM PHOSPHATE, DIBASIC
POTASSIUM CATION
PHOSPHORIC ACID
WATER
ALCOHOL
ZINC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57520-0494	57520-0494-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CHIMAPHILA UMBELLATA WHOLE	WCK21A9W9J	ACTIB
SUS SCROFA PITUITARY GLAND, POSTERIOR	E8S87O660T	ACTIB
SAW PALMETTO	J7WWH9M8QS	ACTIB
ARCTOSTAPHYLOS UVA-URSI LEAF	3M5V3D1X36	ACTIB
GELSEMIUM SEMPERVIRENS ROOT	639KR60Q1Q	ACTIB
SMILAX ORNATA ROOT	2H1576D5WG	ACTIB
POTASSIUM PHOSPHATE, DIBASIC	CI71S98N1Z	ACTIB
PHOSPHORIC ACID	E4GA8884NN	ACTIB
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
ZINC	J41CSQ7QDS	ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9a9dadb7-1f1f-4ae1-9069-bb37dcd4af87			e888278a-e7ef-4b42-b0b7-63afaff45b1c	2025-06-10	Warnings	Exact identifier spl id: 9a9dadb7-1f1f-4ae1-9069-bb37dcd4af87 spl set id: e888278a-e7ef-4b42-b0b7-63afaff45b1c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.