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FDA Approval

Arthritis Pain and Joint Relief

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
King Bio Inc.
DUNS: 617901350
Effective Date
May 19, 2025
Labeling Type
HUMAN OTC DRUG LABEL
actaea spicata root(10 [hp_X] in 59 mL)
Horse chestnut(10 [hp_X] in 59 mL)
bellis perennis whole(10 [hp_X] in 59 mL)
bryonia alba root(10 [hp_X] in 59 mL)
Calcium fluoride(10 [hp_X] in 59 mL)
causticum(10 [hp_X] in 59 mL)
Black cohosh(10 [hp_X] in 59 mL)
Formic acid(10 [hp_X] in 59 mL)
rhododendron tomentosum leafy twig(10 [hp_X] in 59 mL)
Lithium carbonate(10 [hp_X] in 59 mL)
Phosphorus(10 [hp_X] in 59 mL)
pulsatilla vulgaris whole(10 [hp_X] in 59 mL)
rhododendron aureum leaf(10 [hp_X] in 59 mL)
toxicodendron pubescens leaf(10 [hp_X] in 59 mL)
ruta graveolens flowering top(10 [hp_X] in 59 mL)
Salicylic acid(10 [hp_X] in 59 mL)
Zinc(10 [hp_X] in 59 mL)
Arnica montana flower(10 [hp_X] in 59 mL)
Ostrea edulis shell(10 [hp_X] in 59 mL)
Hypericum perforatum Extract(10 [hp_X] in 59 mL)
Phytolacca americana Extract(10 [hp_X] in 59 mL)
Sepia Extract(10 [hp_X] in 59 mL)
Magnesium phosphate(10 [hp_X] in 59 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

King Bio Inc.

617901350

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

King Bio Inc.

King Bio Inc.

King Bio Inc.

617901350

Products1

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

Arthritis Pain and Joint Relief

Product Details

NDC Product Code
57955-6163
Route of Administration
ORAL
Effective Date
May 19, 2025
actaea spicata rootActive
Code: 3FU86L9OS0Class: ACTIBQuantity: 10 [hp_X] in 59 mL
Horse chestnutActive
Code: 3C18L6RJAZClass: ACTIBQuantity: 10 [hp_X] in 59 mL
bellis perennis wholeActive
Code: 2HU33I03UYClass: ACTIBQuantity: 10 [hp_X] in 59 mL
bryonia alba rootActive
Code: T7J046YI2BClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Calcium fluorideActive
Code: O3B55K4YKIClass: ACTIBQuantity: 10 [hp_X] in 59 mL
causticumActive
Code: DD5FO1WKFUClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Black cohoshActive
Code: K73E24S6X9Class: ACTIBQuantity: 10 [hp_X] in 59 mL
Formic acidActive
Code: 0YIW783RG1Class: ACTIBQuantity: 10 [hp_X] in 59 mL
rhododendron tomentosum leafy twigActive
Code: 877L01IZ0PClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Lithium carbonateActive
Code: 2BMD2GNA4VClass: ACTIBQuantity: 10 [hp_X] in 59 mL
PhosphorusActive
Code: 27YLU75U4WClass: ACTIBQuantity: 10 [hp_X] in 59 mL
pulsatilla vulgaris wholeActive
Code: I76KB35JEVClass: ACTIBQuantity: 10 [hp_X] in 59 mL
rhododendron aureum leafActive
Code: IV92NQJ73UClass: ACTIBQuantity: 10 [hp_X] in 59 mL
toxicodendron pubescens leafActive
Code: 6IO182RP7AClass: ACTIBQuantity: 10 [hp_X] in 59 mL
ruta graveolens flowering topActive
Code: N94C2U587SClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Salicylic acidActive
Code: O414PZ4LPZClass: ACTIBQuantity: 10 [hp_X] in 59 mL
ZincActive
Code: J41CSQ7QDSClass: ACTIBQuantity: 10 [hp_X] in 59 mL
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
CITRUS AURANTIUM FRUIT OILInactive
Code: 59JDQ5VT0TClass: IACT
ORANGE PEELInactive
Code: TI9T76XD44Class: IACT
CITRUS RETICULATA FRUIT OILInactive
Code: 25P9H3QU5EClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4YClass: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWRClass: IACT
CARYA OVATA BARKInactive
Code: X765CF609LClass: IACT
STEVIOLInactive
Code: 4741LYX6RTClass: IACT
Arnica montana flowerActive
Code: O80TY208ZWClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Ostrea edulis shellActive
Code: 2E32821G6IClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Hypericum perforatum ExtractActive
Code: XK4IUX8MNBClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Phytolacca americana ExtractActive
Code: 11E6VI8VEGClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Sepia ExtractActive
Code: QDL83WN8C2Class: ACTIBQuantity: 10 [hp_X] in 59 mL
Magnesium phosphateActive
Code: HF539G9L3QClass: ACTIBQuantity: 10 [hp_X] in 59 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description Arthritis Pain and Joint.jpg

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves symptoms:

Backache

Stiff, swollen joints

Leg cramps

Sore tendons and ligaments

Hip and knee discomforts

Irritability

Fatigue

Body aches

Restless limbs

As per various homeopathic materia medicas. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested.

Reference image:Arthritis Pain and Joint.jpg

DOSAGE & ADMINISTRATION SECTION

Directions

Initially, depress pump until
primed.

Spray one dose directly into
mouth.

Adults: 3 sprays 3 times per
day.

Children ages 6-12: 2 sprays 3
times per day.

Consult a physician for use in
children under 6 years of age.

Use additionally as needed, up
to 6 times per day.

Reference image:Arthritis Pain and Joint.jpg

WARNINGS SECTION

Warnings

Stop use and consult a physician if symptoms worsen or
persist for more than 7 days.

If pregnant or breast-feeding, ask a healthcare professional
before use.
Keep out of reach of children.

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

Reference image:Arthritis Pain and Joint.jpg

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Equal volumes of each HPUS ingredient in 10X, 30X, and 1LM
potencies.

Actaea spicata, Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Ledum palustre, Lithium carbonicum, Magnesia phosphorica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus tox, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum.

**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States.

Reference image:Arthritis Pain and Joint.jpg

OTC - PURPOSE SECTION

Equal volumes of each HPUS ingredient in 10X, 30X, and 1LM
potencies.

Actaea spicata....................................................... fatigued joints
Aesculus hippocastanum ........................................ aching limbs
Arnica montana .........................................................body aches
Bellis perennis ............................................... muscular soreness
Bryonia ..................................................................... irritability
Calcarea carbonica ....................................................leg cramps
Calcarea fluorica ..........................................................backache
Causticum ............................................................. muscle aches
Cimicifuga racemosa..................................restless limbs, soreness
Formicum acidum......................................................... stiff joints
Hypericum perforatum.......................................... joint discomfort
Ledum palustre.............................................aching in lower limbs
Lithium carbonicum ................................... aching joints, stiffness
Magnesia phosphorica .................................................leg cramps
Phosphorus ..................................................................backache
Phytolacca decandra...................................................... stiffness
Pulsatilla .................................................hip and joint discomfort
Rhododendron chrysanthum ...................................achy shoulders
Rhus tox .......................................... sore tendons and ligaments
Ruta graveolens ...................................................... restlessness
Salicylicum acidum............................................ knee discomforts
Sepia ...................................................... stiffness, restless limbs
Zincum metallicum .......................................................backache

**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States

Reference image:Arthritis Pain and Joint.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Reference image:Arthritis Pain and Joint.jpg

OTHER SAFETY INFORMATION

Other information
Tamper resistant for your protection.
Use only if safety seal is intact.

Keep carton for complete drug facts and product information.

Questions? Call 866.298.2740

King Bio, Inc. 3 Westside Drive

Asheville, NC 2806 USA

FDA Reg. #1053442

For latest product information and instructions: www.DrKings.com

Reference image: Arthritis Pain and Joint.jpg

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).

Reference image: Arthritis Pain and Joint.jpg

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