FDA.reportPublic FDA data

Ovaplex

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2025-04-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:33:08

Label at a glance#

ProductOvaplex
Active ingredientANGELICA ARCHANGELICA ROOT, CAULOPHYLLUM THALICTROIDES ROOT, DIOSCOREA VILLOSA TUBER, SUS SCROFA OVARY, SUS SCROFA PITUITARY GLAND, THYROID, SUS SCROFA UTERUS, ZINC GLUCONATE, APIS MELLIFERA, ATROPA BELLADONNA, BLACK COHOSH, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SEPIA OFFICINALIS JUICE
Label structure9 sections

Indications and uses

For temporary relief of painful menses and menstrual cramps.

Dosage and administration

• 10 drops orally, 3 times a day. 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

Angelica Archangelica 3X, Apis Mellifica 12X, Belladonna 12X, Caulophyllum Thalictroides 3X, Cimicifuga Racemosa 12X, Dioscorea Villosa 3X, Hypophysis Suis 6X, Magnesia Phosphorica 12X, Oophorinum 6X, Sepia 12X, Thyroidinum 6X, Uterus Suis 6X, Zincum Gluconicum 6X.

PURPOSE:

OTC - PURPOSE SECTION

Angelica Archangelica - nausea,** Apis Mellifica - cramps,** Belladonna – stomach pain,** Caulophyllum Thalictroides – pain during menses,** Cimicifuga Racemosa – minor back pains,** Dioscorea Villosa – abdominal cramps,** Hypophysis Suis – heavy menses,** Magnesia Phosphorica – spasmodic pain,** Oophorinum – hot flashes,** Sepia – irregular menstrual cycles,** Thyroidinum - fatigue,** Uterus Suis – supports the uterus,** Zincum Gluconicum – tiredness in the abdomen**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA Evaluated.

USES:

INDICATIONS & USAGE SECTION

For temporary relief of painful menses and menstrual cramps.

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.

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 DISPLAY LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional
OVAPLEX

HOMEOPATHIC
1 FL OZ (30 mL)

OVAPLEXOVAPLEX

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
95250459-30e4-45c1-b08a-993044f49109Product name220250805
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0204-1Ovaplex30 mL in 1 BOTTLE, DROPPERLIQUID306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0204OVAPLEX (ANGELICA ARCHANGELICA, CAULOPHYLLUM THALICTROIDES, DIOSCOREA VILLOSA, HYPOPHYSIS SUIS, OOPHORINUM (SUIS) THYROIDINUM (SUIS), UTERUS SUIS, ZINCUM GLUCONICUM, APIS MELLIFICA, BELLADONNA, CIMICIFUGA RACEMOSA, MAGNESIA PHOSPHORICA, SEPIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]6Current NDC, Legacy NDC, 1 package rows20250406_cdbc8dc0-ac22-46af-a516-a3b5ca358197.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANGELICA ARCHANGELICA ROOTACTIVE INGREDIENTDTN01M69SN1
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
BLACK COHOSHACTIVE INGREDIENTK73E24S6X91
CAULOPHYLLUM THALICTROIDES ROOTACTIVE INGREDIENTJTJ6HH6YEH1
DIOSCOREA VILLOSA TUBERACTIVE INGREDIENTIWY3IWX2G81
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3Q1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
SUS SCROFA OVARYACTIVE INGREDIENTS7YTV04R8O1
SUS SCROFA PITUITARY GLANDACTIVE INGREDIENTE8S87O660T1
SUS SCROFA THYROIDACTIVE INGREDIENT6RV024OAUQ1
SUS SCROFA UTERUSACTIVE INGREDIENT2595C75F1P1
ZINC GLUCONATEACTIVE INGREDIENTU6WSN5SQ1Z1
ANGELICA ARCHANGELICA ROOTACTIVE MOIETYDTN01M69SN1
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
BLACK COHOSHACTIVE MOIETYK73E24S6X91
CAULOPHYLLUM THALICTROIDES ROOTACTIVE MOIETYJTJ6HH6YEH1
DIOSCOREA VILLOSA TUBERACTIVE MOIETYIWY3IWX2G81
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
SUS SCROFA OVARYACTIVE MOIETYS7YTV04R8O1
SUS SCROFA PITUITARY GLANDACTIVE MOIETYE8S87O660T1
SUS SCROFA THYROIDACTIVE MOIETY6RV024OAUQ1
SUS SCROFA UTERUSACTIVE MOIETY2595C75F1P1
ZINC CATIONACTIVE MOIETY13S1S8SF371
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-020443857-0204-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANGELICA ARCHANGELICA ROOTDTN01M69SNACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
DIOSCOREA VILLOSA TUBERIWY3IWX2G8ACTIB
SUS SCROFA OVARYS7YTV04R8OACTIB
SUS SCROFA PITUITARY GLANDL0PFEMQ1DTACTIB
THYROID6RV024OAUQACTIB
SUS SCROFA UTERUS2595C75F1PACTIB
ZINC GLUCONATEU6WSN5SQ1ZACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BLACK COHOSHK73E24S6X9ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
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
OvaplexANGELICA ARCHANGELICA, CAULOPHYLLUM THALICTROIDES, DIOSCOREA VILLOSA, HYPOPHYSIS SUIS, OOPHORINUM (SUIS) THYROIDINUM (SUIS), UTERUS SUIS, ZINCUM GLUCONICUM, APIS MELLIFICA, BELLADONNA, CIMICIFUGA RACEMOSA, MAGNESIA PHOSPHORICA, SEPIABioActive Nutritional, Inc.cdbc8dc0-ac22-46af-a516-a3b5ca3581972025-04-02WarningsExact identifier
ndc (package): 43857-0204-1
ndc (product): 43857-0204
ndc11 (package): 43857020401
spl id: 695947b4-90e2-4f57-bc17-5eba346c0c71
spl set id: cdbc8dc0-ac22-46af-a516-a3b5ca358197

Reported adverse events (FAERS/openFDA)#

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