FDA.reportPublic FDA data

Mood Balancer

Manufacturer
Nutritional Specialties, Inc.
Effective date
2023-10-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:22:32

Label at a glance#

ProductMood Balancer
Active ingredientLITHIUM CARBONATE, SUS SCROFA CEREBELLUM, SUS SCROFA CEREBRUM, SUS SCROFA HYPOTHALAMUS, SUS SCROFA PINEAL GLAND, GOLD, SODIUM SULFATE, SEPIA OFFICINALIS JUICE, SEROTONIN HYDROCHLORIDE
Label structure9 sections

Dosage and administration

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Lithium Carbonicum 6X, Cerebellum 6X, 12X, 30X, 60X, Cerebrum Suis 6X, 12X, 30X, 60X, Hypothalamus Suis 6X, 12X, 30X, 60X, Pineal Gland 6X, 12X, 30X, 60X, Aurum Metallicum 12X, Natrum Sulphuricum 12X, Sepia 12X, Serotonin 12X, 16X.

PURPOSE:

OTC - PURPOSE SECTION

Aids in mood balance.†

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

WARNINGS:

WARNINGS SECTION

Professional Use Only

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

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

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

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

Store in a cool place after opening

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: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

Aids in mood balance.†

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

OTC - QUESTIONS SECTION

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Professional

Health Products

HOMEOPATHIC

NDC 83027-0109-1

MOOD

BALANCER

2 FL. OZ (60 ml)

MOOD BALANCERMOOD BALANCER

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0109-1Mood Balancer60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0109MOOD BALANCER (LITHIUM CARBONICUM, CEREBELLUM (SUIS), CEREBRUM SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), AURUM METALLICUM, NATRUM SULPHURICUM, SEPIA, SEROTONIN (HYDROCHLORIDE)) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20231007_b1beb5b4-994e-4e7e-a669-7787d810fa1f.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83027-010983027-0109-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LITHIUM CARBONATE2BMD2GNA4VACTIB
SUS SCROFA CEREBELLUM49NGK53TPQACTIB
SUS SCROFA CEREBRUM4GB5DQR532ACTIB
SUS SCROFA HYPOTHALAMUSN6R0856Z79ACTIB
SUS SCROFA PINEAL GLAND050QZ2EDK7ACTIB
GOLD79Y1949PYOACTIB
SODIUM SULFATE0YPR65R21JACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SEROTONIN HYDROCHLORIDEGKN429M9VSACTIB
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
Mood BalancerLITHIUM CARBONICUM, CEREBELLUM (SUIS), CEREBRUM SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), AURUM METALLICUM, NATRUM SULPHURICUM, SEPIA, SEROTONIN (HYDROCHLORIDE)Nutritional Specialties, Inc.b1beb5b4-994e-4e7e-a669-7787d810fa1f2023-10-05WarningsExact identifier
ndc (package): 83027-0109-1
ndc (product): 83027-0109
ndc11 (package): 83027010901
spl id: 0094d78a-2f44-4b06-8bb8-bd756b921f74
spl set id: b1beb5b4-994e-4e7e-a669-7787d810fa1f

Reported adverse events (FAERS/openFDA)#

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