FDA.reportPublic FDA data

ARTHRONEW

Product NDC
61045-0001
11-digit product format
610450001
Labeler code
61045
Product ID
61045-0001_0100aeb7-4a73-4571-b476-73ecf8c61269
Type
HUMAN OTC DRUG
Nonproprietary name
Symphytum Officinale, Capsicum Annuum, Ledum Palustre, colchicum Autumnale, Rhododendron Chrysanthum, Ruta Graveolens
Dosage form
GEL
Route
TOPICAL
Labeler
PureCore Wellness, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-11-03
Marketing end
2026-08-21
Substance
CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP
Active strength
6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ARTHRONEW
Brand name suffix
AM

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSICUM6 [hp_X]/g
COLCHICUM AUTUMNALE BULB12 [hp_X]/g
COMFREY ROOT3 [hp_X]/g
LEDUM PALUSTRE TWIG6 [hp_X]/g
RHODODENDRON AUREUM LEAF12 [hp_X]/g
RUTA GRAVEOLENS FLOWERING TOP12 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00UK7646FG, 993QHL78E6, M9VVZ08EKQ, 877L01IZ0P, IV92NQJ73U, N94C2U587S

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61045-0001-12020-01-31C16284748780-19d75b9cf-e162-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61045-0001-1ARTHRONEWAM85 g in 1 TUBEGEL853

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSICUMACTIVE INGREDIENT00UK7646FGARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
COLCHICUM AUTUMNALE BULBACTIVE INGREDIENT993QHL78E6ARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
COMFREY ROOTACTIVE INGREDIENTM9VVZ08EKQARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0PARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
RHODODENDRON AUREUM LEAFACTIVE INGREDIENTIV92NQJ73UARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587SARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
CAPSICUMACTIVE MOIETY00UK7646FGARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
COLCHICUM AUTUMNALE BULBACTIVE MOIETY993QHL78E6ARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
COMFREY ROOTACTIVE MOIETYM9VVZ08EKQARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0PARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
RHODODENDRON AUREUM LEAFACTIVE MOIETYIV92NQJ73UARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587SARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1ARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
CELERY SEEDINACTIVE INGREDIENT1G1EAA320LARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839XARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
FEVERFEWINACTIVE INGREDIENTZ64FK7P217ARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
HARPAGOPHYTUM PROCUMBENS ROOTINACTIVE INGREDIENT1OYM338E89ARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
OREGANOINACTIVE INGREDIENT0E5AT8T16UARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764ODARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
PHYTOLACCA AMERICANA ROOTINACTIVE INGREDIENT11E6VI8VEGARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
POLYETHYLENE GLYCOL 700INACTIVE INGREDIENT762678AC5RARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H7ARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
TURMERICINACTIVE INGREDIENT856YO1Z64FARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61045-0001ARTHRONEW AM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC.]2Current NDC, Legacy NDC, 1 package rows20141106_6c625f9a-cb9c-4e44-9546-49924039dbfe.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61045-0001-16104500010185 g in 1 TUBE (61045-0001-1) 85 g2014-11-032026-08-21NoNoHistorical