FDA.reportPublic FDA data

Calm Five

Manufacturer
Energetix Corporation
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:36:10

Label at a glance#

ProductCalm Five
Active ingredientCLEMATIS VITALBA FLOWER, HELIANTHEMUM NUMMULARIUM FLOWER, IMPATIENS GLANDULIFERA FLOWER, ORNITHOGALUM UMBELLATUM, PRUNUS CERASIFERA FLOWER
Label structure8 sections

Indications and uses

Temporary relief of agitation, shock, fear.

Dosage and administration

Take 30 drops orally twice daily or as directed by a healthcare professional.  Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

59.1 mL contains 20% of Clematis vitalba, flos 30C (Clematis); Helianthemum nummularium, flos 30C (Rock Rose); Impatiens glandulifera, flos 30C (Impatiens); Ornithogalum umbellatum, flos 30C (Star of Bethlehem); Prunus cerasifera, flos 30C (Cherry Plum).

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

Uses

INDICATIONS & USAGE SECTION

Temporary relief of agitation, shock, fear.

Warnings

WARNINGS SECTION

  • In case of overdose, get medical help or contact a Poison Control Center right away. 
  • If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take 30 drops orally twice daily or as directed by a healthcare professional. 
  • Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature out of direct sunlight.
  • Do not use if neck wrap is broken or missing.
  • Shake well before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cane Alcohol, Vegetable Glycerin, Purified Water.

OTC - QUESTIONS SECTION

Distributed by Energetix Corp.
Dahlonega, GA 30533
Questions? Comments?
800.990.7085
www.energetix.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

energetix

Calm Five

Homeopathic Remedy

Agitation, shock, fear

2 fl oz (59.1 mL) / 15% Cane Alcohol

Calm Five r08-25Calm Five r08-25

OTC - PURPOSE SECTION

PurposeTemporary relief of agitation, shock, fear.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64578-0157-1Calm Five59.1 mL in 1 BOTTLELIQUID59.17

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64578-015764578-0157-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CLEMATIS VITALBA FLOWER7SCP4N87CIACTIB
HELIANTHEMUM NUMMULARIUM FLOWER51BRR32WPPACTIB
IMPATIENS GLANDULIFERA FLOWERAJU5O1A5ZVACTIB
ORNITHOGALUM UMBELLATUM9NS3M2Y78SACTIB
PRUNUS CERASIFERA FLOWER0KD7R09EASACTIB
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
Calm FiveCLEMATIS VITALBA FLOS, HELIANTHEMUM NUMMULARIUM FLOS, IMPATIENS GLANDULIFERA FLOS, ORNITHOGALUM UMBELLATUM FLOS, PRUNUS CERASIFERA FLOSEnergetix Corporation701f1b95-e662-4879-b231-c6862280c1342025-12-17WarningsExact identifier
ndc (package): 64578-0157-1
ndc (product): 64578-0157
ndc11 (package): 64578015701
spl id: 462afe8a-0631-77f2-e063-6294a90ada4d
spl set id: 701f1b95-e662-4879-b231-c6862280c134

Reported adverse events (FAERS/openFDA)#

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