FDA.reportPublic FDA data

Menopause

Manufacturer
Liddell Laboratories, Inc. | Apotheca Company
Effective date
2024-07-01
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:27:27

Label at a glance#

ProductMenopause
Active ingredientCHASTE TREE, ANGELICA SINENSIS ROOT, APIS MELLIFERA, AMERICAN GINSENG, ARNICA MONTANA WHOLE, BLACK COHOSH, GALIUM APARINE WHOLE, GLYCYRRHIZA GLABRA, SUS SCROFA OVARY, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG, VISCUM ALBUM FRUITING TOP
Label structure9 sections

Indications and uses

May temporarily relieve these symptoms associated with hormonal imbalance, which may accompany menopause: •mood swings •hot flashes •irritability •vaginal dryness •lack of sexual vitality ** **These statements are based upon traditional homeopathic practice.  They have not been reviewed by the Food and Drug Administration.

Dosage and administration

Adults only :  Spray twice under the tongue three times a day.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Agnus castus 3X, Angelica sinensis radix 3X, Apis mellifica 6X, Aralia quinquefolia 3X, Arnica montana 6X, Cimicifuga racemosa 3X, Galium aparine 3X, Glycyrrhiza glabra 3X, Oophorinum suis 30C, Sepia 30C, Thuja occidentalis 6X, Viscum album 3X.

USES:

OTC - PURPOSE SECTION

May temporarily relieve these symptoms associated with hormonal imbalance, which may accompany menopause:

•mood swings

•hot flashes

•irritability

•vaginal dryness

•lack of sexual vitality **

**These statements are based upon traditional homeopathic practice.  They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.

Keep out of reach of children.  In case of overdose, get medical help or call a Poison Control Center right away.

If pregnant or breast feeding, ask a doctor before using product.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Other information.  Store at room temperature.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  In case of overdose, get medical help or call a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults only:  Spray twice under the tongue three times a day.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve these symptoms associated with hormonal imbalance, which may accompany menopause:

•mood swings

•hot flashes

•irritability

•vaginal dryness

•lack of sexual vitality **

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Organic alcohol 20% v/v, Purified water.

QUESTIONS:

OTC - QUESTIONS SECTION

DIST. BY

LIDDELL LABORATORIES, INC.

201 APPLE BLVD.

WOODBINE, IA 51579

www.LIDDELL.NET

1-800-460-7733

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORAL SPRAYS

LIDDELL LABORATORIES
EST. 1994

07   MP

Menopause
with Black Cohosh

May relieve menopausal symptoms: hormonal imbalance, emotional fluctuations, hot flashes + irritability.

HOMEOPATHIC

DOCTOR FORMULATED

Readily absorbed. Safe. No known side effects. Easy to use.

1.0 FL OZ (30 ml)

Menopause CTNMenopause CTN

Menopause LBLMenopause LBL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0092-22024-07-01C16284748780-19d75b9d0-da7a-f424-e053-dadaa90a57ceDRUG FACTS:
50845-0092-22024-01-30C16284748780-19d75b9d0-da7a-f424-e053-dadaa90a57ceDRUG FACTS:
50845-0092-22021-12-16C16284748780-19d75b9d0-da7a-f424-e053-dadaa90a57ceDRUG FACTS:
50845-0092-22020-01-31C16284748780-19d75b9d0-da7a-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0092-1Menopause30 mL in 1 BOTTLE, SPRAYLIQUID307
50845-0092-2Menopause1 in 1 CARTONLIQUID17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0092MENOPAUSE (AGNUS CASTUS, ANGELICA SINENSIS RADIX, APIS MELLIFICA, ARALIA QUINQUEFOLIA, ARNICA MONTANA, CIMICIFUGA RACEMOSA, GALIUM APARINE, GLYCYRRHIZA GLABRA, OOPHORINUM SUIS, SEPIA, THUJA OCCIDENTALIS, VISCUM ALBUM) LIQUID [LIDDELL LABORATORIES, INC.]7Current NDC, Legacy NDC, 2 package rows20240702_3e17fa78-f5c2-47eb-9bb6-075ccffd01b6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMERICAN GINSENGACTIVE INGREDIENT8W75VCV53Q2
ANGELICA SINENSIS ROOTACTIVE INGREDIENTB66F4574UG2
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z2
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW2
BLACK COHOSHACTIVE INGREDIENTK73E24S6X92
CHASTE TREEACTIVE INGREDIENT433OSF3U8A2
GALIUM APARINEACTIVE INGREDIENTZ4B65614882
GLYCYRRHIZA GLABRAACTIVE INGREDIENT2788Z9758H2
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C22
SUS SCROFA OVARYACTIVE INGREDIENTS7YTV04R8O2
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93972
VISCUM ALBUM FRUITING TOPACTIVE INGREDIENTBK9092J5MP2
AMERICAN GINSENGACTIVE MOIETY8W75VCV53Q2
ANGELICA SINENSIS ROOTACTIVE MOIETYB66F4574UG2
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z2
ARNICA MONTANAACTIVE MOIETYO80TY208ZW2
BLACK COHOSHACTIVE MOIETYK73E24S6X92
CHASTE TREEACTIVE MOIETY433OSF3U8A2
GALIUM APARINEACTIVE MOIETYZ4B65614882
GLYCYRRHIZA GLABRAACTIVE MOIETY2788Z9758H2
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C22
SUS SCROFA OVARYACTIVE MOIETYS7YTV04R8O2
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93972
VISCUM ALBUM FRUITING TOPACTIVE MOIETYBK9092J5MP2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50845-009250845-0092-1, 50845-0092-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHASTE TREE433OSF3U8AACTIB
ANGELICA SINENSIS ROOTB66F4574UGACTIB
APIS MELLIFERA7S82P3R43ZACTIB
AMERICAN GINSENG8W75VCV53QACTIB
ARNICA MONTANA WHOLEO80TY208ZWACTIB
BLACK COHOSHK73E24S6X9ACTIB
GALIUM APARINE WHOLEZ4B6561488ACTIB
GLYCYRRHIZA GLABRA2788Z9758HACTIB
SUS SCROFA OVARYS7YTV04R8OACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
VISCUM ALBUM FRUITING TOPBK9092J5MPACTIB
WATER059QF0KO0RIACT
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 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
3 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
MenopauseAGNUS CASTUS, ANGELICA SINENSIS RADIX, APIS MELLIFICA, ARALIA QUINQUEFOLIA, ARNICA MONTANA, CIMICIFUGA RACEMOSA, GALIUM APARINE, GLYCYRRHIZA GLABRA, OOPHORINUM SUIS, SEPIA, THUJA OCCIDENTALIS, VISCUM ALBUMLiddell Laboratories, Inc.3e17fa78-f5c2-47eb-9bb6-075ccffd01b62024-07-01WarningsExact identifier
ndc (package): 50845-0092-2
ndc (package): 50845-0092-1
ndc (product): 50845-0092
ndc11 (package): 50845009202
ndc11 (package): 50845009201
spl id: 2f80d111-fe7c-419f-8bbb-ef7dfb1017d6
spl set id: 3e17fa78-f5c2-47eb-9bb6-075ccffd01b6

Reported adverse events (FAERS/openFDA)#

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