FDA.reportPublic FDA data

Joint Tone AI

Product NDC
44911-0587
11-digit product format
449110587
Labeler code
44911
Product ID
44911-0587_3e2c6f05-ef33-468a-aa73-2e8e64f3a44b
Type
HUMAN OTC DRUG
Nonproprietary name
Cimicifuga Racemosa, Lappa Major, Trifolium Pratense, Colchicum Autumnale, Dulcamara, Lycopodium Clavatum, Pulsatilla (Pratensis), Rhododendron Chrysanthum, Rhus Tox
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-06-21
Substance
ARCTIUM LAPPA ROOT; BLACK COHOSH; COLCHICUM AUTUMNALE BULB; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PRATENSIS WHOLE; RHODODENDRON AUREUM LEAF; SOLANUM DULCAMARA TOP; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER
Active strength
3; 3; 12; 12; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Joint Tone AI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARCTIUM LAPPA ROOT3 [hp_X]/mL
BLACK COHOSH3 [hp_X]/mL
COLCHICUM AUTUMNALE BULB12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE12 [hp_X]/mL
RHODODENDRON AUREUM LEAF12 [hp_X]/mL
SOLANUM DULCAMARA TOP12 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF12 [hp_X]/mL
TRIFOLIUM PRATENSE FLOWER3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii597E9BI3Z3, K73E24S6X9, 993QHL78E6, C88X29Y479, 8E272251DI, IV92NQJ73U, KPS1B1162N, 6IO182RP7A, 4JS0838828

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0587-14491105870130 mL in 1 BOTTLE, DROPPER (44911-0587-1) 30 ml2021-06-210000-00-00NoNoCurrent