FDA.reportPublic FDA data

Libido

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:49

Label at a glance#

ProductLibido
Active ingredientChaste Tree, American Ginseng, Barium Carbonate, Berberis Vulgaris Root Bark, Bryonia Alba Root, Dieffenbachia Seguine, Lytta Vesicatoria, Causticum, Chelidonium Majus, Cinchona Officinalis Bark, Conium Maculatum Flowering Top, Gaultheria Procumbens Top, Graphite, Potassium Carbonate, Lycopodium Clavatum Spore, Strychnos Nux-vomica Seed, Onosmodium Virginianum Whole, Phosphorus, Saw Palmetto, Selenium, Sepia Officinalis Juice, Silicon Dioxide, Delphinium Staphisagria Seed, Goldenseal, Thuja Occidentalis Leafy Twig
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Libido  Formulated for symptoms associated with libido imbalance such as decreased desire, dryness, impotence, anxiety and hypersexuality.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.   Adults, take 6 drops orally one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Agnus 15x, Aralia quinquefolia 15x, Baryta carb. 15x, Berber. vulg. 15x, Bryonia 15x, Caladium seguinum 15x, Cantharis 15x, Causticum 15x, Chelidonium majus 15x, Cinchona 15x, Conium 15x, Gaultheria procumbens 15x, Graphites 15x, Kali carb. 15x, Lycopodium 15x, Nux vom. 15x, Onosmodium virginianum 15x, Phosphorus 15x, Sabal 15x, Selenium 15x, Sepia 15x, Silicea 15x, Staphysag. 15x, Hydrastis 3x, Thuja occ. 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with libido imbalance such as decreased desire, dryness, impotence, anxiety and hypersexuality.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children. 

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2264-02020-01-31C16284748780-19d75b9d0-3eb6-f424-e053-dadaa90a57ceLibido
55714-2264-12020-01-31C16284748780-19d75b9d0-3eb6-f424-e053-dadaa90a57ceLibido
55714-2264-22020-01-31C16284748780-19d75b9d0-3eb6-f424-e053-dadaa90a57ceLibido

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2264-0Libido.5 mL in 1 BOTTLE, GLASSLIQUID.52
55714-2264-1Libido29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-2264-2Libido59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2264LIBIDO (AGNUS, ARALIA QUINQUEFOLIA, BARYTA CARB., BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA, CONIUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARB., LYCOPODIUM, NUX VOM., ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL, SELENIUM, SEPIA, SILICEA, STAPHYSAG., HYDRASTIS, THUJA OCC) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 3 package rows20130806_dbb07e71-50aa-5213-0db4-7dd21e1bd7f4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
American GinsengACTIVE INGREDIENT8W75VCV53Q2
Barium CarbonateACTIVE INGREDIENT6P669D8HQ82
Berberis Vulgaris Root BarkACTIVE INGREDIENT1TH8Q20J0U2
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
CausticumACTIVE INGREDIENTDD5FO1WKFU2
Chaste TreeACTIVE INGREDIENT433OSF3U8A2
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN2
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB2
Conium Maculatum Flowering TopACTIVE INGREDIENTQ28R5GF3712
Delphinium Staphisagria SeedACTIVE INGREDIENT00543AP1JV2
Dieffenbachia SeguineACTIVE INGREDIENT01800C6E6B2
Gaultheria Procumbens TopACTIVE INGREDIENT830295X9632
GoldensealACTIVE INGREDIENTZW3Z11D0JV2
GraphiteACTIVE INGREDIENT4QQN74LH4O2
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4792
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT2
Onosmodium Virginianum WholeACTIVE INGREDIENT604NK4250S2
PhosphorusACTIVE INGREDIENT27YLU75U4W2
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA2
Saw PalmettoACTIVE INGREDIENTJ7WWH9M8QS2
SeleniumACTIVE INGREDIENTH6241UJ22B2
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C22
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU42
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
Thuja Occidentalis Leafy TwigACTIVE INGREDIENT1NT28V93972
American GinsengACTIVE MOIETY8W75VCV53Q2
Barium CationACTIVE MOIETYV645272HLN2
Berberis Vulgaris Root BarkACTIVE MOIETY1TH8Q20J0U2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Carbonate IonACTIVE MOIETY7UJQ5OPE7D2
CausticumACTIVE MOIETYDD5FO1WKFU2
Chaste TreeACTIVE MOIETY433OSF3U8A2
Chelidonium MajusACTIVE MOIETY7E889U5RNN2
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB2
Conium Maculatum Flowering TopACTIVE MOIETYQ28R5GF3712
Delphinium Staphisagria SeedACTIVE MOIETY00543AP1JV2
Dieffenbachia SeguineACTIVE MOIETY01800C6E6B2
Gaultheria Procumbens TopACTIVE MOIETY830295X9632
GoldensealACTIVE MOIETYZW3Z11D0JV2
GraphiteACTIVE MOIETY4QQN74LH4O2
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4792
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT2
Onosmodium Virginianum WholeACTIVE MOIETY604NK4250S2
PhosphorusACTIVE MOIETY27YLU75U4W2
Saw PalmettoACTIVE MOIETYJ7WWH9M8QS2
SeleniumACTIVE MOIETYH6241UJ22B2
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C22
Silicon DioxideACTIVE MOIETYETJ7Z6XBU42
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
Thuja Occidentalis Leafy TwigACTIVE MOIETY1NT28V93972
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-226455714-2264-1, 55714-2264-2, 55714-2264-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
Chaste Tree433OSF3U8AACTIB
American Ginseng8W75VCV53QACTIB
Barium Carbonate6P669D8HQ8ACTIB
Berberis Vulgaris Root Bark1TH8Q20J0UACTIB
Bryonia Alba RootT7J046YI2BACTIB
Dieffenbachia Seguine01800C6E6BACTIB
Lytta Vesicatoria3Q034RO3BTACTIB
CausticumDD5FO1WKFUACTIB
Chelidonium Majus7E889U5RNNACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Conium Maculatum Flowering TopQ28R5GF371ACTIB
Gaultheria Procumbens Top830295X963ACTIB
Graphite4QQN74LH4OACTIB
Potassium CarbonateBQN1B9B9HAACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Onosmodium Virginianum Whole604NK4250SACTIB
Phosphorus27YLU75U4WACTIB
Saw PalmettoJ7WWH9M8QSACTIB
SeleniumH6241UJ22BACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
Delphinium Staphisagria Seed00543AP1JVACTIB
GoldensealZW3Z11D0JVACTIB
Thuja Occidentalis Leafy Twig1NT28V9397ACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

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 ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
196a99e0-7404-edd7-13ba-d764e4c74eeedbb07e71-50aa-5213-0db4-7dd21e1bd7f42011-03-01WarningsExact identifier
spl id: 196a99e0-7404-edd7-13ba-d764e4c74eee
spl set id: dbb07e71-50aa-5213-0db4-7dd21e1bd7f4

Reported adverse events (FAERS/openFDA)#

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