FDA.reportPublic FDA data

Menopause

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:52

Label at a glance#

ProductMenopause
Active ingredientCROTALUS HORRIDUS HORRIDUS VENOM, STRYCHNOS IGNATII SEED, TURNERA DIFFUSA LEAFY TWIG, NITROGLYCERIN, CHAMAELIRIUM LUTEUM ROOT, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, NAJA NAJA VENOM, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PULSATILLA, SALIX NIGRA BARK, SANGUINARIA CANADENSIS ROOT, SEPIA OFFICINALIS JUICE, ECHINACEA, UNSPECIFIED, VALERIAN, MICRURUS CORALLINUS VENOM, CHASTE TREE FRUIT, ANGELICA SINENSIS ROOT, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, LYTTA VESICATORIA, CAULOPHYLLUM THALICTROIDES ROOT, BLACK COHOSH, CINCHONA OFFICINALIS BARK
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Adults, take 6 drops by mouth one to four times daily or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 11x, Valeriana officinalis 11x, Agnus castus 15x, Angelica sinensis radix 15x, Bryonia 15x, Cantharis 15x, Caulophyllum thalictroides 15x, Cimicifuga racemosa 15x, Cinchona officinalis 15x, Crotalus horridus 15x, Damiana 15x, Glonoinum 15x, Helonias dioica 15x, Ignatia amara 15x, Kali carbonicum 15x, Lachesis mutus 15x, Naja tripudians 15x, Phosphorus 15x, Pulsatilla 15x, Salix nigra 15x, Sanguinaria canadensis 15x, Sepia 15x, Arsenicum album 20x, Nux vomica 20x, Elaps corallinus 35x.

OTC - PURPOSE SECTION

Formulated for associated symptoms 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 alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

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

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. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4800-1Menopause30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4800MENOPAUSE (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.]2Current NDC, Legacy NDC, 1 package rows20201205_995f6b76-b98e-0d32-e053-2995a90a14fe.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-480055714-4800-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
TURNERA DIFFUSA LEAFY TWIGRQ2CFA7WWJACTIB
NITROGLYCERING59M7S0WS3ACTIB
CHAMAELIRIUM LUTEUM ROOTDQV54Y5H3UACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
NAJA NAJA VENOMZZ4AG7L7VMACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SALIX NIGRA BARKQU52J3A5B3ACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
VALERIANJWF5YAW3QWACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
MICRURUS CORALLINUS VENOMV0S6H36980ACTIB
CHASTE TREE FRUIT433OSF3U8AACTIB
ANGELICA SINENSIS ROOTB66F4574UGACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
BLACK COHOSHK73E24S6X9ACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB

Source Document#

Source XML

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
MenopauseELAPS 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, VALERIANANewton Laboratories, Inc.995f6b76-b98e-0d32-e053-2995a90a14fe2020-12-04WarningsExact identifier
ndc (package): 55714-4800-1
ndc (product): 55714-4800
ndc11 (package): 55714480001
spl id: b5aac7bb-52f7-7f8e-e053-2a95a90a1ae6
spl set id: 995f6b76-b98e-0d32-e053-2995a90a14fe

Reported adverse events (FAERS/openFDA)#

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