MedPath

Libido

Libido 2476P

Approved
Approval ID

9c348fa7-1d68-4975-e053-2995a90a0ca6

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

Newton Laboratories, Inc.

DUNS: 788793610

Products 1

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

Hydrastis canadensis, Thuja occidentalis, Agnus castus, Aralia quinquefolia, Baryta carbonica, Berberis vulgaris, Bryonia, Caladium seguinum, Cantharis, Causticum, Chelidonium majus, Cinchona officinalis, Conium maculatum, Gaultheria procumbens, Graphites, Kali carbonicum, Lycopodium clavatum, Nux vomica, Onosmodium virginianum, Phosphorus, Sabal serrulata, Selenium metallicum, Sepia, Silicea, Staphysagria

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55714-2476
Product Classification
G
Generic Name
Hydrastis canadensis, Thuja occidentalis, Agnus castus, Aralia quinquefolia, Baryta carbonica, Berberis vulgaris, Bryonia, Caladium seguinum, Cantharis, Causticum, Chelidonium majus, Cinchona officinalis, Conium maculatum, Gaultheria procumbens, Graphites, Kali carbonicum, Lycopodium clavatum, Nux vomica, Onosmodium virginianum, Phosphorus, Sabal serrulata, Selenium metallicum, Sepia, Silicea, Staphysagria
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (26)

SEPIA OFFICINALIS JUICEActive
Quantity: 15 [hp_X] in 1 g
Code: QDL83WN8C2
Classification: ACTIB
DELPHINIUM STAPHISAGRIA SEEDActive
Quantity: 15 [hp_X] in 1 g
Code: 00543AP1JV
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GOLDENSEALActive
Quantity: 6 [hp_X] in 1 g
Code: ZW3Z11D0JV
Classification: ACTIB
CHASTE TREE FRUITActive
Quantity: 15 [hp_X] in 1 g
Code: 433OSF3U8A
Classification: ACTIB
AMERICAN GINSENGActive
Quantity: 15 [hp_X] in 1 g
Code: 8W75VCV53Q
Classification: ACTIB
BARIUM CARBONATEActive
Quantity: 15 [hp_X] in 1 g
Code: 6P669D8HQ8
Classification: ACTIB
LYTTA VESICATORIAActive
Quantity: 15 [hp_X] in 1 g
Code: 3Q034RO3BT
Classification: ACTIB
BERBERIS VULGARIS ROOT BARKActive
Quantity: 15 [hp_X] in 1 g
Code: 1TH8Q20J0U
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 15 [hp_X] in 1 g
Code: T7J046YI2B
Classification: ACTIB
DIEFFENBACHIA SEGUINEActive
Quantity: 15 [hp_X] in 1 g
Code: 01800C6E6B
Classification: ACTIB
CAUSTICUMActive
Quantity: 15 [hp_X] in 1 g
Code: DD5FO1WKFU
Classification: ACTIB
CHELIDONIUM MAJUSActive
Quantity: 15 [hp_X] in 1 g
Code: 7E889U5RNN
Classification: ACTIB
CINCHONA OFFICINALIS BARKActive
Quantity: 15 [hp_X] in 1 g
Code: S003A158SB
Classification: ACTIB
CONIUM MACULATUM FLOWERING TOPActive
Quantity: 15 [hp_X] in 1 g
Code: Q28R5GF371
Classification: ACTIB
GAULTHERIA PROCUMBENS TOPActive
Quantity: 15 [hp_X] in 1 g
Code: 830295X963
Classification: ACTIB
GRAPHITEActive
Quantity: 15 [hp_X] in 1 g
Code: 4QQN74LH4O
Classification: ACTIB
POTASSIUM CARBONATEActive
Quantity: 15 [hp_X] in 1 g
Code: BQN1B9B9HA
Classification: ACTIB
LYCOPODIUM CLAVATUM SPOREActive
Quantity: 15 [hp_X] in 1 g
Code: C88X29Y479
Classification: ACTIB
STRYCHNOS NUX-VOMICA SEEDActive
Quantity: 15 [hp_X] in 1 g
Code: 269XH13919
Classification: ACTIB
ONOSMODIUM VIRGINIANUMActive
Quantity: 15 [hp_X] in 1 g
Code: 604NK4250S
Classification: ACTIB
PHOSPHORUSActive
Quantity: 15 [hp_X] in 1 g
Code: 27YLU75U4W
Classification: ACTIB
SAW PALMETTOActive
Quantity: 15 [hp_X] in 1 g
Code: J7WWH9M8QS
Classification: ACTIB
SELENIUMActive
Quantity: 15 [hp_X] in 1 g
Code: H6241UJ22B
Classification: ACTIB
THUJA OCCIDENTALIS LEAFY TWIGActive
Quantity: 6 [hp_X] in 1 g
Code: 1NT28V9397
Classification: ACTIB
SILICON DIOXIDEActive
Quantity: 15 [hp_X] in 1 g
Code: ETJ7Z6XBU4
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

PACKAGE LABEL

Package label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/19/2025

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as decreased desire, dryness, anxiety and hypersexuality.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2019

DOSAGE & ADMINISTRATION SECTION

**Directions:**Adults, take 6 pellets by mouth one to four times daily or as directed by a health professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2019

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Hydrastis canadensis 6x, Thuja occidentalis 6x, Agnus castus 15x, Aralia quinquefolia 15x, Baryta carbonica 15x, Berberis vulgaris 15x, Bryonia 15x, Caladium seguinum 15x, Cantharis 15x, Causticum 15x, Chelidonium majus 15x, Cinchona officinalis 15x, Conium maculatum 15x, Gaultheria procumbens 15x, Graphites 15x, Kali carbonicum 15x, Lycopodium clavatum 15x, Nux vomica 15x, Onosmodium virginianum 15x, Phosphorus 15x, Sabal serrulata 15x, Selenium metallicum 15x, Sepia 15x, Silicea 15x, Staphysagria 15x.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/19/2025

OTC - PURPOSE SECTION

Formulated for associated symptoms such as decreased desire, dryness, anxiety and hypersexuality.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2019

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/1/2019

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2019

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. Ifpregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 1/1/2019

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ifpregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2019

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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