BALANCE

Manufacturer: BDMP, LLC | Adjunct Therapeutics Manufacturing, LLC
Effective date: 2013-02-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:04:21

Label at a glance#

ProductBALANCE

Active ingredientBRYONIA ALBA ROOT, STRYCHNOS IGNATII SEED, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, SEPIA OFFICINALIS JUICE

Label structure12 sections

Indications and uses

Temporarily relieves symptoms of menstrual irregularities such as: membrane dryness, hot flashes, sleeplessness, weakness or faintness, perspiration, sexual frigidity and minor headache pain as per Homeopathic Materia Medica.

Dosage and administration

Shake well before using. Spay 3 to 6 sprays under the tongue 3 times a day or as needed. Adults and children under 18 years of age consult a physician.

Storage and handling

Safety-sealed for your protection. Do not use if seal is missing or broken.

Contacts and useful links#

PhoneLabel contact877-272-6611

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Each dose contains:

Bryonia 10C, 20C, 30C HPUS

Ignatia 10C, 20C, 30C HPUS

Nux Vom 10C, 20C, 30C HPUS

Phos 10C, 20C, 30C HPUS

Sepia 10C, 20C, 30C HPUS

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

OTC - PURPOSE SECTION

Bryonia 10C, 20C, 30C HPUS.....................Minor headache, Sleeplessness

Ignatia 10C, 20C, 30C HPUS......................Sexual frigidity, Changeable mood

Nux Vom 10C, 20C, 30C HPUS..................Faintness, Sleeplessness

Phos 10C, 20C, 30C HPUS........................Aversion to coitus, Great indifference

Sepia 10C, 20C, 30C HPUS........................Hot flashes, Weakness

Uses

INDICATIONS & USAGE SECTION

Warnings

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before using. Spay 3 to 6 sprays under the tongue 3 times a day or as needed. Adults and children under 18 years of age consult a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Barbasco Extract, Black Cohosh Extract, Damiana, Eleuthero, Malic Acid, Muira Puama,

Natural Flavors, Potassium Sorbate, Sodium Benzoate, Stevia Leaf Extract, Tribulus, Water.

STORAGE AND HANDLING SECTION

Safety-sealed for your protection. Do not use if seal is missing or broken.

OTC - QUESTIONS SECTION

Questions? Comments?

877-272-6611

Distributed by

BDMP LLC

1080 Bichara Boulevard

Lady Lake, Fl. 32159

Made in the USA

DESCRIPTION SECTION

Temporarily relieves symptoms of menstrual irregularities such as hot flashes, sleeplessness, weakness or

faintness and low libido.

Homeopathic Spray

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM1

NDC 54616-001-00

BALANCE

BY FEMBALANCE

2 fl oz (60 mL) Homeopathic Spray

Temporarily relieves symptoms of menstrual irregularities such as

hot flashes sleeplessness, weakness or faintness and low libido.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54616-001-60	2019-11-27	C162847	48780-1	9855d018-d994-cd31-e053-dbdaa90ab51a	8010500e-451e-4a80-9908-20950e8f69f9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54616-001-60	BALANCE	1 in 1 CARTON	SPRAY	1		1
54616-001-60	BALANCE	60 mL in 1 BOTTLE, SPRAY	SPRAY	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54616-001	BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ]	1	Legacy NDC, 2 package rows	20130227_8010500e-451e-4a80-9908-20950e8f69f9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BRYONIA ALBA ROOT	ACTIVE INGREDIENT	T7J046YI2B	1
PHOSPHORUS	ACTIVE INGREDIENT	27YLU75U4W	1
SEPIA OFFICINALIS JUICE	ACTIVE INGREDIENT	QDL83WN8C2	1
STRYCHNOS IGNATII SEED	ACTIVE INGREDIENT	1NM3M2487K	1
STRYCHNOS NUX-VOMICA SEED	ACTIVE INGREDIENT	269XH13919	1
BRYONIA ALBA ROOT	ACTIVE MOIETY	T7J046YI2B	1
PHOSPHORUS	ACTIVE MOIETY	27YLU75U4W	1
SEPIA OFFICINALIS JUICE	ACTIVE MOIETY	QDL83WN8C2	1
STRYCHNOS IGNATII SEED	ACTIVE MOIETY	1NM3M2487K	1
STRYCHNOS NUX-VOMICA SEED	ACTIVE MOIETY	269XH13919	1
BARBASCO	INACTIVE INGREDIENT	5ZAQ44W04C	1
BLACK COHOSH	INACTIVE INGREDIENT	K73E24S6X9	1
DULACIA INOPIFLORA WOOD	INACTIVE INGREDIENT	K04M7D9VEC	1
ELEUTHERO	INACTIVE INGREDIENT	ZQH6VH092Z	1
MALIC ACID	INACTIVE INGREDIENT	817L1N4CKP	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
STEVIA REBAUDIUNA LEAF	INACTIVE INGREDIENT	6TC6NN0876	1
TRIBULUS TERRESTRIS	INACTIVE INGREDIENT	4X4HLN92OT	1
TURNERA DIFFUSA LEAFY TWIG	INACTIVE INGREDIENT	RQ2CFA7WWJ	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

BALANCE
Bryonia, Ignatia, Nux Vom, Phos, Sepia
BRYONIA ALBA ROOT
STRYCHNOS IGNATII SEED
STRYCHNOS NUX-VOMICA SEED
PHOSPHORUS
SEPIA OFFICINALIS JUICE
BARBASCO
BLACK COHOSH
TURNERA DIFFUSA LEAFY TWIG
ELEUTHERO
MALIC ACID
DULACIA INOPIFLORA WOOD
POTASSIUM SORBATE
SODIUM BENZOATE
STEVIA REBAUDIUNA LEAF
TRIBULUS TERRESTRIS
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54616-001	54616-001-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BRYONIA ALBA ROOT	T7J046YI2B	ACTIB
STRYCHNOS IGNATII SEED	1NM3M2487K	ACTIB
STRYCHNOS NUX-VOMICA SEED	269XH13919	ACTIB
PHOSPHORUS	27YLU75U4W	ACTIB
SEPIA OFFICINALIS JUICE	QDL83WN8C2	ACTIB
BARBASCO	5ZAQ44W04C	IACT
BLACK COHOSH	K73E24S6X9	IACT
TURNERA DIFFUSA LEAFY TWIG	RQ2CFA7WWJ	IACT
ELEUTHERO	ZQH6VH092Z	IACT
MALIC ACID	817L1N4CKP	IACT
DULACIA INOPIFLORA WOOD	K04M7D9VEC	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
STEVIA REBAUDIUNA LEAF	6TC6NN0876	IACT
TRIBULUS TERRESTRIS	4X4HLN92OT	IACT
WATER	059QF0KO0R	IACT

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SPRAY, METERED / NASAL	0.06 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
MALIC ACID	MALIC ACID	817L1N4CKP	SUSPENSION / ORAL		180 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, EMULSION / INTRAVENOUS	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CREAM / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, DELAYED RELEASE / ORAL	0.34 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	EMULSION / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii candidate 19 equally ranked IID candidates
MALIC ACID	MALIC ACID	817L1N4CKP	SOLUTION / ORAL		16760 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MALIC ACID	MALIC ACID	817L1N4CKP	POWDER, FOR SUSPENSION / ORAL		1392 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / RECTAL	6.67 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / TOPICAL		5 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, SOLUTION / INTRAMUSCULAR	4.8 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
MALIC ACID	MALIC ACID	817L1N4CKP	TABLET / ORAL		20 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAMUSCULAR		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION/ DROPS / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	PASTE / ORAL		48 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	AEROSOL, FOAM / TOPICAL		8 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MALIC ACID	MALIC ACID	817L1N4CKP	POWDER, FOR SOLUTION / ORAL		1230 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / RECTAL		406 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 35 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
3dc4cafe-10de-489f-8d54-94538a3678b1			8010500e-451e-4a80-9908-20950e8f69f9	2013-02-21	Warnings	Exact identifier spl id: 3dc4cafe-10de-489f-8d54-94538a3678b1 spl set id: 8010500e-451e-4a80-9908-20950e8f69f9

Reported adverse events (FAERS/openFDA)#

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