FDA.reportPublic FDA data

Rheumatic Joint Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:44

Label at a glance#

ProductRheumatic Joint Care
Active ingredientUric Acid, Aconitum Napellus, Apis Mellifera, Arnica Montana, Arsenic Trioxide, Atropa Belladonna, Benzoic Acid, Bryonia Alba Root, Oyster Shell Calcium Carbonate, Crude, Matricaria Recutita, Cinchona Officinalis Bark, Colchicum Autumnale Bulb, Eupatorium Perfoliatum Flowering Top, Gaultheria Procumbens Top, Guaiacum Officinale Resin, Iodine, Potassium Dichromate, Kalmia Latifolia Leaf, Ledum Palustre Twig, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, Ruta Graveolens Flowering Top, Juniperus Sabina Leafy Twig, Strychnine, Arctium Lappa Root, Phytolacca Americana Root, Comfrey Root
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Rheumatic - Joint Care  Formulated for symptoms associated with uric acid build-up such as joint pain, inflammation and discomfort.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Uricum acidum 15x, Aconitum nap. 10x, Apis mel. 10x, Arnica 10x, Arsenicum alb. 10x, Belladonna 10x, Benzoicum acidum 10x, Bryonia 10x, Calc. carb. 10x, Chamomilla 10x, Cinchona 10x, Colchicum 10x, Eupatorium perf. 10x, Gaultheria procumbens 10x, Guaiacum 10x, Iodium 10x, Kali bic. 10x, Kalmia 10x, Ledum 10x, Pulsatilla 10x, Rhus toxicodendron 10x, Ruta 10x, Sabina 10x, Strychninum 10x, Lappa 3x, Phytolacca 3x, Symphytum 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with uric acid build-up such as joint pain, inflammation and discomfort.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2216-02020-01-31C16284748780-19d75b9d1-1a76-f424-e053-dadaa90a57ceRheumatic - Joint Care
55714-2216-12020-01-31C16284748780-19d75b9d1-1a76-f424-e053-dadaa90a57ceRheumatic - Joint Care
55714-2216-22020-01-31C16284748780-19d75b9d1-1a76-f424-e053-dadaa90a57ceRheumatic - Joint Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2216-0Rheumatic Joint Care.5 mL in 1 BOTTLE, GLASSLIQUID.52
55714-2216-1Rheumatic Joint Care29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-2216-2Rheumatic Joint Care59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2216RHEUMATIC JOINT CARE (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,) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 3 package rows20130726_7e7f186f-b6f4-1f25-620b-83cb3e8363f6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD2
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z2
Arctium Lappa RootACTIVE INGREDIENT597E9BI3Z32
Arnica MontanaACTIVE INGREDIENTO80TY208ZW2
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H2
Benzoic AcidACTIVE INGREDIENT8SKN0B0MIM2
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB2
Colchicum Autumnale BulbACTIVE INGREDIENT993QHL78E62
Comfrey RootACTIVE INGREDIENTM9VVZ08EKQ2
Eupatorium Perfoliatum Flowering TopACTIVE INGREDIENT1W0775VX6E2
Gaultheria Procumbens TopACTIVE INGREDIENT830295X9632
Guaiacum Officinale ResinACTIVE INGREDIENTN0K2Z502R62
IodineACTIVE INGREDIENT9679TC07X42
Juniperus Sabina Leafy TwigACTIVE INGREDIENTZ5BEX9K2G12
Kalmia Latifolia LeafACTIVE INGREDIENT79N6542N182
Ledum Palustre TwigACTIVE INGREDIENT877L01IZ0P2
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ2
Oyster Shell Calcium Carbonate, CrudeACTIVE INGREDIENT2E32821G6I2
Phytolacca Americana RootACTIVE INGREDIENT11E6VI8VEG2
Potassium DichromateACTIVE INGREDIENTT4423S18FM2
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV2
Ruta Graveolens Flowering TopACTIVE INGREDIENTN94C2U587S2
StrychnineACTIVE INGREDIENTH9Y79VD43J2
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A2
Uric AcidACTIVE INGREDIENT268B43MJ252
Aconitum NapellusACTIVE MOIETYU0NQ8555JD2
Apis MelliferaACTIVE MOIETY7S82P3R43Z2
Arctium Lappa RootACTIVE MOIETY597E9BI3Z32
Arnica MontanaACTIVE MOIETYO80TY208ZW2
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H2
Benzoic AcidACTIVE MOIETY8SKN0B0MIM2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB2
Colchicum Autumnale BulbACTIVE MOIETY993QHL78E62
Comfrey RootACTIVE MOIETYM9VVZ08EKQ2
Dichromate IonACTIVE MOIETY9LKY4BFN2V2
Eupatorium Perfoliatum Flowering TopACTIVE MOIETY1W0775VX6E2
Gaultheria Procumbens TopACTIVE MOIETY830295X9632
Guaiacum Officinale ResinACTIVE MOIETYN0K2Z502R62
IodineACTIVE MOIETY9679TC07X42
Juniperus Sabina Leafy TwigACTIVE MOIETYZ5BEX9K2G12
Kalmia Latifolia LeafACTIVE MOIETY79N6542N182
Ledum Palustre TwigACTIVE MOIETY877L01IZ0P2
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ2
Oyster Shell Calcium Carbonate, CrudeACTIVE MOIETY2E32821G6I2
Phytolacca Americana RootACTIVE MOIETY11E6VI8VEG2
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV2
Ruta Graveolens Flowering TopACTIVE MOIETYN94C2U587S2
StrychnineACTIVE MOIETYH9Y79VD43J2
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A2
Uric AcidACTIVE MOIETY268B43MJ252
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-221655714-2216-1, 55714-2216-2, 55714-2216-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
Uric Acid268B43MJ25ACTIB
Aconitum NapellusU0NQ8555JDACTIB
Apis Mellifera7S82P3R43ZACTIB
Arnica MontanaO80TY208ZWACTIB
Arsenic TrioxideS7V92P67HOACTIB
Atropa BelladonnaWQZ3G9PF0HACTIB
Benzoic Acid8SKN0B0MIMACTIB
Bryonia Alba RootT7J046YI2BACTIB
Oyster Shell Calcium Carbonate, Crude2E32821G6IACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Colchicum Autumnale Bulb993QHL78E6ACTIB
Eupatorium Perfoliatum Flowering Top1W0775VX6EACTIB
Gaultheria Procumbens Top830295X963ACTIB
Guaiacum Officinale ResinN0K2Z502R6ACTIB
Iodine9679TC07X4ACTIB
Potassium DichromateT4423S18FMACTIB
Kalmia Latifolia Leaf79N6542N18ACTIB
Ledum Palustre Twig877L01IZ0PACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Ruta Graveolens Flowering TopN94C2U587SACTIB
Juniperus Sabina Leafy TwigZ5BEX9K2G1ACTIB
StrychnineH9Y79VD43JACTIB
Arctium Lappa Root597E9BI3Z3ACTIB
Phytolacca Americana Root11E6VI8VEGACTIB
Comfrey RootM9VVZ08EKQACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
4d6fdfdb-fe73-450a-cfe8-cec6fc35ec5a7e7f186f-b6f4-1f25-620b-83cb3e8363f62011-03-01WarningsExact identifier
spl id: 4d6fdfdb-fe73-450a-cfe8-cec6fc35ec5a
spl set id: 7e7f186f-b6f4-1f25-620b-83cb3e8363f6

Reported adverse events (FAERS/openFDA)#

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