MedPath

Joint Care

Joint 4861L

Approved
Approval ID

3f2b75d8-89f1-8d67-e063-6294a90a0166

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

Newton Laboratories, Inc.

DUNS: 788793610

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Uricum acidum, Aconitum nap.,Apis mel., Arnica, Arsenicum alb, Belladonna,Benzoicum acidum, Bryonia, Calc. carb., Chamomilla, Cinchona, Colchicum, Eupatorium perf., Gaultheriaprocumbens, Guaiacum, Iodium, Kali bic, Kalmia,Ledum, Pulsatilla, Rhus toxicodendron, Ruta,Sabina, Strychninum, Lappa, Phytolacca, Symphytum,

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55714-4861
Product Classification
G
Generic Name
Uricum acidum, Aconitum nap.,Apis mel., Arnica, Arsenicum alb, Belladonna,Benzoicum acidum, Bryonia, Calc. carb., Chamomilla, Cinchona, Colchicum, Eupatorium perf., Gaultheriaprocumbens, Guaiacum, Iodium, Kali bic, Kalmia,Ledum, Pulsatilla, Rhus toxicodendron, Ruta,Sabina, Strychninum, Lappa, Phytolacca, Symphytum,
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (29)

MATRICARIA CHAMOMILLAActive
Quantity: 20 [hp_X] in 1 mL
Code: G0R4UBI2ZZ
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
URIC ACIDActive
Quantity: 20 [hp_X] in 1 mL
Code: 268B43MJ25
Classification: ACTIB
ACONITUM NAPELLUSActive
Quantity: 20 [hp_X] in 1 mL
Code: U0NQ8555JD
Classification: ACTIB
APIS MELLIFERAActive
Quantity: 20 [hp_X] in 1 mL
Code: 7S82P3R43Z
Classification: ACTIB
ARNICA MONTANAActive
Quantity: 20 [hp_X] in 1 mL
Code: O80TY208ZW
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 20 [hp_X] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
ATROPA BELLADONNAActive
Quantity: 20 [hp_X] in 1 mL
Code: WQZ3G9PF0H
Classification: ACTIB
BENZOIC ACIDActive
Quantity: 20 [hp_X] in 1 mL
Code: 8SKN0B0MIM
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 20 [hp_X] in 1 mL
Code: T7J046YI2B
Classification: ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDEActive
Quantity: 20 [hp_X] in 1 mL
Code: 2E32821G6I
Classification: ACTIB
CINCHONA OFFICINALIS BARKActive
Quantity: 20 [hp_X] in 1 mL
Code: S003A158SB
Classification: ACTIB
GUAIACUM OFFICINALE RESINActive
Quantity: 20 [hp_X] in 1 mL
Code: N0K2Z502R6
Classification: ACTIB
COLCHICUM AUTUMNALE BULBActive
Quantity: 20 [hp_X] in 1 mL
Code: 993QHL78E6
Classification: ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOPActive
Quantity: 20 [hp_X] in 1 mL
Code: 1W0775VX6E
Classification: ACTIB
GAULTHERIA PROCUMBENS TOPActive
Quantity: 20 [hp_X] in 1 mL
Code: 830295X963
Classification: ACTIB
IODINEActive
Quantity: 20 [hp_X] in 1 mL
Code: 9679TC07X4
Classification: ACTIB
POTASSIUM DICHROMATEActive
Quantity: 20 [hp_X] in 1 mL
Code: T4423S18FM
Classification: ACTIB
KALMIA LATIFOLIA LEAFActive
Quantity: 20 [hp_X] in 1 mL
Code: 79N6542N18
Classification: ACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIGActive
Quantity: 20 [hp_X] in 1 mL
Code: 877L01IZ0P
Classification: ACTIB
ANEMONE PULSATILLAActive
Quantity: 20 [hp_X] in 1 mL
Code: I76KB35JEV
Classification: ACTIB
TOXICODENDRON PUBESCENS LEAFActive
Quantity: 20 [hp_X] in 1 mL
Code: 6IO182RP7A
Classification: ACTIB
RUTA GRAVEOLENS FLOWERING TOPActive
Quantity: 20 [hp_X] in 1 mL
Code: N94C2U587S
Classification: ACTIB
JUNIPERUS SABINA LEAFY TWIGActive
Quantity: 20 [hp_X] in 1 mL
Code: Z5BEX9K2G1
Classification: ACTIB
STRYCHNINEActive
Quantity: 20 [hp_X] in 1 mL
Code: H9Y79VD43J
Classification: ACTIB
ARCTIUM LAPPA ROOTActive
Quantity: 11 [hp_X] in 1 mL
Code: 597E9BI3Z3
Classification: ACTIB
PHYTOLACCA AMERICANA ROOTActive
Quantity: 11 [hp_X] in 1 mL
Code: 11E6VI8VEG
Classification: ACTIB
COMFREY ROOTActive
Quantity: 11 [hp_X] in 1 mL
Code: M9VVZ08EKQ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

PACKAGE LABEL

Package label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/19/2025

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as pain in hip and shoulder joints and pain in small joints of hands and feet.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/19/2025

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/19/2025

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/19/2025

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/19/2025

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Lappa 11x, Phytolacca 11x, Symphytum 11x, Aconitum nap 20x, Apis mel 20x, Arnica 20x, Arsenicum alb 20x, Belladonna 20x, Benzoicum ac 20x, Bryonia 20x, Calc carb 20x, Chamomilla 20x, Cinchona 20x, Colchicum 20x, Eupatorium perf 20x, Gaultheria 20x, Guaiacum 20x, Iodium 20x, Kali bic 20x, Kalmia 20x, Ledum 20x, Pulsatilla 20x, Rhus tox 20x, Ruta 20x, Sabina 20x, Strychninum 20x, Uricum ac 20x.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/19/2025

OTC - PURPOSE SECTION

Formulated for associated symptoms such as pain in hip and shoulder joints and pain in small joints of hands and feet.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/19/2025

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. Ifpregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 9/19/2025

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ifpregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/19/2025

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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Joint Care - FDA Drug Approval Details