FDA.reportPublic FDA data

ARTHRONEW

Product NDC
61045-0002
11-digit product format
610450002
Labeler code
61045
Product ID
61045-0002_b462b556-ef06-4d1e-8385-9ceb057e349f
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica Montana, Hamamelis Virginiana, Rhus Toxicodendron
Dosage form
GEL
Route
TOPICAL
Labeler
PureCore Wellness, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-11-03
Marketing end
2026-06-30
Substance
ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF
Active strength
6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ARTHRONEW
Brand name suffix
PM

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA6 [hp_X]/g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK6 [hp_X]/g
TOXICODENDRON PUBESCENS LEAF6 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO80TY208ZW, T7S323PKJS, 6IO182RP7A

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
61045-0002-12020-01-31C16284748780-19d75b9d0-0cd6-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61045-0002-1ARTHRONEWPM57 g in 1 TUBEGEL573

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE INGREDIENTT7S323PKJSARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7AARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
ARNICA MONTANAACTIVE MOIETYO80TY208ZWARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE MOIETYT7S323PKJSARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7AARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1ARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
HAMAMELIS VIRGINIANA BARKINACTIVE INGREDIENTIH3063S9MYARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
HARPAGOPHYTUM PROCUMBENS ROOTINACTIVE INGREDIENT1OYM338E89ARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
MENTHA PIPERITA LEAFINACTIVE INGREDIENTA389O33LX6ARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
OREGANOINACTIVE INGREDIENT0E5AT8T16UARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764ODARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
POLYETHYLENE GLYCOL 700INACTIVE INGREDIENT762678AC5RARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H7ARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2
WATERINACTIVE INGREDIENT059QF0KO0RARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61045-0002ARTHRONEW PM (NOT APPLICABLE) GEL [PURECORE WELLNESS, INC]2Current NDC, Legacy NDC, 1 package rows20141106_3bdf50ce-6909-4db9-8691-a789718466cd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61045-0002-16104500020157 g in 1 TUBE (61045-0002-1) 57 g2014-11-032026-06-30NoNoHistorical