FDA.reportPublic FDA data

Menopause HP

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:36:03

Label at a glance#

ProductMenopause HP
Active ingredientATROPA BELLADONNA, LACHESIS MUTA VENOM, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS WHOLE, CLAVICEPS PURPUREA SCLEROTIUM, SEPIA OFFICINALIS JUICE, USTILAGO MAYDIS
Label structure9 sections

Indications and uses

For temporary relief of mood swings, flushes of heat and physical weakness due to menopause.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Belladonna 30X, Lachesis Mutus 30X, Nux Vomica 30X, Pulsatilla 30X, Secale Cornutum 30X, Sepia 30X, Ustilago Maidis 30X.

PURPOSE:

OTC - PURPOSE SECTION

Belladonna - fever,** Lachesis Mutus - headache,** Nux Vomica - stomach cramps,** Pulsatilla - PMS,** Secale Cornutum - painful menstruation,** Sepia - irregular menses,** Ustilago Maidis - heavy menstruation**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

For temporary relief of mood swings, flushes of heat and physical weakness due to menopause.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

​If pregnant or breast-feeding,​ ask a health care professional before use.

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

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BIOActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

MENOPAUSE HP

HOMEOPATHIC

1 fl. oz. (30 mL)

MENOPAUSE HPMENOPAUSE HP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130210184340759GTIN-13: 0210184340759
EAN-13: 0210184340759
GTIN-12: 210184340759
UPC-A: 210184340759
GTIN storage (14 digits): 00210184340759		BANI0183 Menopause-HP 6-10-25.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0203-1Menopause HP30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
CLAVICEPS PURPUREA SCLEROTIUMACTIVE INGREDIENT01G9XEA93N1
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07I1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
USTILAGO MAYDISACTIVE INGREDIENT4K7Z7K7SWG1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
CLAVICEPS PURPUREA SCLEROTIUMACTIVE MOIETY01G9XEA93N1
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07I1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
USTILAGO MAYDISACTIVE MOIETY4K7Z7K7SWG1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-020343857-0203-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
USTILAGO MAYDIS4K7Z7K7SWGACTIB
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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 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
Menopause HPBELLADONNA, LACHESIS MUTUS, NUX VOMICA, PULSATILLA (VULGARIS), SECALE CORNUTUM, SEPIA, USTILAGO MAIDISBioActive Nutritional, Inc.0f0aea3f-95d2-4a81-8180-cf675eeb7f622025-12-17WarningsExact identifier
ndc (package): 43857-0203-1
ndc (product): 43857-0203
ndc11 (package): 43857020301
spl id: 8900dc93-f5c1-4fd5-b4f9-fd57c92ccc2d
spl set id: 0f0aea3f-95d2-4a81-8180-cf675eeb7f62

Reported adverse events (FAERS/openFDA)#

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