FDA.reportPublic FDA data

Menopause

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 02:04:45

Label at a glance#

ProductMenopause
Active ingredientMicrurus Corallinus Venom, Chaste Tree, Angelica Sinensis Root, Arsenic Trioxide, Bryonia Alba Root, Lytta Vesicatoria, Caulophyllum Thalictroides Root, Black Cohosh, Cinchona Officinalis Bark, Crotalus Horridus Horridus Venom, Turnera Diffusa Leafy Twig, Nitroglycerin, Chamaelirium Luteum Root, Strychnos Ignatii Seed, Potassium Carbonate, Lachesis Muta Venom, Naja Naja Venom, Strychnos Nux-vomica Seed, Phosphorus, Pulsatilla Vulgaris, Salix Nigra Bark, Sanguinaria Canadensis Root, Sepia Officinalis Juice, Echinacea, Unspecified, Valerian
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Menopause  Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

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

Elaps corallinus 30x, Agnus 10x, Angelica sinensis radix 10x, Arsenicum alb. 10x, Bryonia 10x, Cantharis 10x, Caulophyllum 10x, Cimicifuga 10x, Cinchona 10x, Crotalus horridus 10x, Damiana 10x, Glonoinum 10x, Helonias dioica 10x, Ignatia 10x, Kali carb. 10x, Lachesis 10x, Naja 10x, Nux vom.10x, Phosphorus 10x, Pulsatilla 10x, Salix nigra 10x, Sanguinaria 10x, Sepia 10x, Echinacea 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

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
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2234-02020-01-31C16284748780-19d75b9cf-e777-f424-e053-dadaa90a57ceMenopause
55714-2234-12020-01-31C16284748780-19d75b9cf-e777-f424-e053-dadaa90a57ceMenopause
55714-2234-22020-01-31C16284748780-19d75b9cf-e777-f424-e053-dadaa90a57ceMenopause

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2234-0Menopause.5 mL in 1 BOTTLE, GLASSLIQUID.52
55714-2234-1Menopause29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-2234-2Menopause59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2234MENOPAUSE (ELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANA) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 3 package rows20130730_b6d4e669-866c-97e7-40a2-f970d6676b12.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Angelica Sinensis RootACTIVE INGREDIENTB66F4574UG2
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Black CohoshACTIVE INGREDIENTK73E24S6X92
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Caulophyllum Thalictroides RootACTIVE INGREDIENTJTJ6HH6YEH2
Chamaelirium Luteum RootACTIVE INGREDIENTDQV54Y5H3U2
Chaste TreeACTIVE INGREDIENT433OSF3U8A2
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB2
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9562
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I2
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT2
Micrurus Corallinus VenomACTIVE INGREDIENTV0S6H369802
Naja Naja VenomACTIVE INGREDIENTZZ4AG7L7VM2
NitroglycerinACTIVE INGREDIENTG59M7S0WS32
PhosphorusACTIVE INGREDIENT27YLU75U4W2
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA2
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV2
Salix Nigra BarkACTIVE INGREDIENTQU52J3A5B32
Sanguinaria Canadensis RootACTIVE INGREDIENTN9288CD5082
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C22
Strychnos Ignatii SeedACTIVE INGREDIENT1NM3M2487K2
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
Turnera Diffusa Leafy TwigACTIVE INGREDIENTRQ2CFA7WWJ2
ValerianACTIVE INGREDIENTJWF5YAW3QW2
Angelica Sinensis RootACTIVE MOIETYB66F4574UG2
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Black CohoshACTIVE MOIETYK73E24S6X92
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Carbonate IonACTIVE MOIETY7UJQ5OPE7D2
Caulophyllum Thalictroides RootACTIVE MOIETYJTJ6HH6YEH2
Chamaelirium Luteum RootACTIVE MOIETYDQV54Y5H3U2
Chaste TreeACTIVE MOIETY433OSF3U8A2
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB2
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9562
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I2
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT2
Micrurus Corallinus VenomACTIVE MOIETYV0S6H369802
Naja Naja VenomACTIVE MOIETYZZ4AG7L7VM2
NitroglycerinACTIVE MOIETYG59M7S0WS32
PhosphorusACTIVE MOIETY27YLU75U4W2
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV2
Salix Nigra BarkACTIVE MOIETYQU52J3A5B32
Sanguinaria Canadensis RootACTIVE MOIETYN9288CD5082
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C22
Strychnos Ignatii SeedACTIVE MOIETY1NM3M2487K2
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
Turnera Diffusa Leafy TwigACTIVE MOIETYRQ2CFA7WWJ2
ValerianACTIVE MOIETYJWF5YAW3QW2
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
55714-223455714-2234-1, 55714-2234-2, 55714-2234-0

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
Micrurus Corallinus VenomV0S6H36980ACTIB
Chaste Tree433OSF3U8AACTIB
Angelica Sinensis RootB66F4574UGACTIB
Arsenic TrioxideS7V92P67HOACTIB
Bryonia Alba RootT7J046YI2BACTIB
Lytta Vesicatoria3Q034RO3BTACTIB
Caulophyllum Thalictroides RootJTJ6HH6YEHACTIB
Black CohoshK73E24S6X9ACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Crotalus Horridus Horridus VenomYHA2XLJ956ACTIB
Turnera Diffusa Leafy TwigRQ2CFA7WWJACTIB
NitroglycerinG59M7S0WS3ACTIB
Chamaelirium Luteum RootDQV54Y5H3UACTIB
Strychnos Ignatii Seed1NM3M2487KACTIB
Potassium CarbonateBQN1B9B9HAACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Naja Naja VenomZZ4AG7L7VMACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Phosphorus27YLU75U4WACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Salix Nigra BarkQU52J3A5B3ACTIB
Sanguinaria Canadensis RootN9288CD508ACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
ValerianJWF5YAW3QWACTIB
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
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact 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
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact 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
e61c2a0b-f1ff-3747-81a2-21bb534af2a0b6d4e669-866c-97e7-40a2-f970d6676b122011-03-01WarningsExact identifier
spl id: e61c2a0b-f1ff-3747-81a2-21bb534af2a0
spl set id: b6d4e669-866c-97e7-40a2-f970d6676b12

Reported adverse events (FAERS/openFDA)#

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