FDA.reportPublic FDA data

Joint Tone AI

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2023-10-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:22:28

Label at a glance#

ProductJoint Tone AI
Active ingredientBLACK COHOSH, ARCTIUM LAPPA ROOT, TRIFOLIUM PRATENSE FLOWER, COLCHICUM AUTUMNALE BULB, SOLANUM DULCAMARA TOP, LYCOPODIUM CLAVATUM SPORE, PULSATILLA PRATENSIS WHOLE, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAF
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 16.62% of Colchicum Autumnale 12X, Dulcamara 12X, Lycopodium Clavatum 12X, Pulsatilla (Pratensis) 12X, Rhododendron Chrysanthum 12X, Rhus Tox 12X; 0.10% of Cimicifuga Racemosa 3X, Lappa Major 3X, Trifolium Pratense 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve pain and swelling of shoulder, arm, fingers, and small joints, and stiffness of the hands and feet.**

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

WARNINGS:

WARNINGS SECTION

If pregnant or breastfeeding, 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 and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve pain and swelling of shoulder, arm, fingers, and small joints, and stiffness of the hands and feet.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.
201 Apple Blvd.
Woodbine, IA 51579   800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
JOINT TONE AI
1 fl. oz. (30 ml)

Joint Tone AIJoint Tone AI

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0587-12023-10-04C16284748780-1f386c64a-06d9-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0587-12023-01-30C16284748780-1f386c64a-06d9-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0587-1Joint Tone AI30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0587JOINT TONE AI (CIMICIFUGA RACEMOSA, LAPPA MAJOR, TRIFOLIUM PRATENSE, COLCHICUM AUTUMNALE, DULCAMARA, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), RHODODENDRON CHRYSANTHUM, RHUS TOX) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20231005_bcd543aa-eb43-455e-9a73-37323f050e24.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-058744911-0587-1

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
BLACK COHOSHK73E24S6X9ACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PULSATILLA PRATENSIS WHOLE8E272251DIACTIB
RHODODENDRON AUREUM LEAFIV92NQJ73UACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
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
Joint Tone AICIMICIFUGA RACEMOSA, LAPPA MAJOR, TRIFOLIUM PRATENSE, COLCHICUM AUTUMNALE, DULCAMARA, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), RHODODENDRON CHRYSANTHUM, RHUS TOXEnergique, Inc.bcd543aa-eb43-455e-9a73-37323f050e242023-10-04WarningsExact identifier
ndc (package): 44911-0587-1
ndc (product): 44911-0587
ndc11 (package): 44911058701
spl id: 3e2c6f05-ef33-468a-aa73-2e8e64f3a44b
spl set id: bcd543aa-eb43-455e-9a73-37323f050e24

Reported adverse events (FAERS/openFDA)#

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