FDA.reportPublic FDA data

Body Balance

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-02-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:26:05

Label at a glance#

ProductBody Balance
Active ingredientAVENA SATIVA FLOWERING TOP, CHLOROPHYTUM BORIVILIANUM WHOLE, PUNICA GRANATUM ROOT BARK, NUPHAR LUTEA ROOT, BOS TAURUS HYPOTHALAMUS, SUS SCROFA TESTICLE, TURNERA DIFFUSA LEAFY TWIG, SELENIUM, DELPHINIUM STAPHISAGRIA SEED, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Dosage and administration

Adults only. Spray 2 times under the tongue 2 times a day. If symptoms persist, consult your health care professional.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each spray): 6.64% of Damiana 9X, Granatum 6X, Hypothalamus Suis 6X, 12X, 30X, 12C, 30C, Nuphar Luteum 6X, Orchitinum (Suis) 6X, 12X, 30X, 12C, 30C, Staphysagria 9X, Thuja Occidentalis 12X;0.10% of Avena Sativa 3X, Chlorophytum Borivilianum 3X, Selenium Metallicum 9X.

INDICATIONS:

OTC - PURPOSE SECTION

Temporarily relieves symptoms of low sexual energy and dysfunction which may be due to prostatitis, endometritis, endometriosis, low or poor sperm production, fatigue and decreased responsiveness.**

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

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health 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

Adults only. Spray 2 times under the tongue 2 times a day. If symptoms persist, consult your health care professional.

INDICATIONS:

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms of low sexual energy and dysfunction which may be due to prostatitis, endometritis, endometriosis, low or poor sperm production, fatigue and decreased responsiveness.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Citric acid, Demineralized water, 25% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800.869.8078

PACKAGE DISPLAY LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

BODY BALANCE

1 fl. oz. (30 ml) 

Body BalanceBody Balance

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0635-12024-02-14C16284748780-1f386c64a-474f-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0635-12023-01-30C16284748780-1f386c64a-474f-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0635-1Body Balance30 mL in 1 BOTTLE, SPRAYSPRAY303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0635BODY BALANCE (AVENA SATIVA, CHLOROPHYTUM BORIVILIANUM, NUPHAR LUTEUM, HYPOTHALAMUS SUIS, ORCHITINUM (SUIS), DAMIANA, SELENIUM METALLICUM, STAPHYSAGRIA, THUJA OCCIDENTALIS) SPRAY [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240216_d8e70220-b3ef-4595-a8c3-a77a6bd373e4.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-063544911-0635-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
CHLOROPHYTUM BORIVILIANUM WHOLEB0MD133CE7ACTIB
PUNICA GRANATUM ROOT BARKCLV24I3T1DACTIB
NUPHAR LUTEA ROOT714LIU3V6DACTIB
BOS TAURUS HYPOTHALAMUSS6G2NLH4Y7ACTIB
SUS SCROFA TESTICLEKM02613O28ACTIB
TURNERA DIFFUSA LEAFY TWIGRQ2CFA7WWJACTIB
SELENIUMH6241UJ22BACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
Body BalanceAVENA SATIVA, CHLOROPHYTUM BORIVILIANUM, NUPHAR LUTEUM, HYPOTHALAMUS SUIS, ORCHITINUM (SUIS), DAMIANA, SELENIUM METALLICUM, STAPHYSAGRIA, THUJA OCCIDENTALISEnergique, Inc.d8e70220-b3ef-4595-a8c3-a77a6bd373e42024-02-14WarningsExact identifier
ndc (package): 44911-0635-1
ndc (product): 44911-0635
ndc11 (package): 44911063501
spl id: a35365e2-3091-45cd-acde-e02a0b0a779a
spl set id: d8e70220-b3ef-4595-a8c3-a77a6bd373e4

Reported adverse events (FAERS/openFDA)#

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