FDA.reportPublic FDA data

Fibrocane Relief

Product NDC
57850-2000
11-digit product format
578502000
Labeler code
57850
Product ID
57850-2000_42c04f05-6d86-4472-a603-7966390a04ea
Type
HUMAN OTC DRUG
Nonproprietary name
Symphytum officinale, Capsicum annuum, Ledum palustre, Colchicum autumnale, Rhododendron chrysanthum, Ruta graveolens,
Dosage form
GEL
Route
TOPICAL
Labeler
Premier Bioceuticals LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-06-17
Marketing end
0000-00-00
Substance
COMFREY ROOT; CAPSICUM; LEDUM PALUSTRE TWIG; COLCHICUM AUTUMNALE BULB; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP
Active strength
3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
57850-2000-12020-01-31C16284748780-19d75b9d1-2280-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57850-2000-1Fibrocane Relief57 g in 1 TUBEGEL572

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSICUMACTIVE INGREDIENT00UK7646FGFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
COLCHICUM AUTUMNALE BULBACTIVE INGREDIENT993QHL78E6FIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
COMFREY ROOTACTIVE INGREDIENTM9VVZ08EKQFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0PFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
RHODODENDRON AUREUM LEAFACTIVE INGREDIENTIV92NQJ73UFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587SFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
CAPSICUMACTIVE MOIETY00UK7646FGFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
COLCHICUM AUTUMNALE BULBACTIVE MOIETY993QHL78E6FIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
COMFREY ROOTACTIVE MOIETYM9VVZ08EKQFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0PFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
RHODODENDRON AUREUM LEAFACTIVE MOIETYIV92NQJ73UFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587SFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1FIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
CELERY SEEDINACTIVE INGREDIENT1G1EAA320LFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839XFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
FEVERFEWINACTIVE INGREDIENTZ64FK7P217FIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
HARPAGOPHYTUM PROCUMBENS ROOTINACTIVE INGREDIENT1OYM338E89FIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
OREGANOINACTIVE INGREDIENT0E5AT8T16UFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764ODFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
PHYTOLACCA AMERICANA ROOTINACTIVE INGREDIENT11E6VI8VEGFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
POLYETHYLENE GLYCOL 700INACTIVE INGREDIENT762678AC5RFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4FIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H7FIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
TURMERICINACTIVE INGREDIENT856YO1Z64FFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RFIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57850-2000FIBROCANE RELIEF (SYMPHYTUM OFFICINALE, CAPSICUM ANNUUM, LEDUM PALUSTRE, COLCHICUM AUTUMNALE, RHODODENDRON CHRYSANTHUM, RUTA GRAVEOLENS,) GEL [PREMIER BIOCEUTICALS LLC]2Legacy NDC, 1 package rows20140701_3f6db893-fd40-4f01-a869-96923322b7f7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
57850-2000-15785020000157 g in 1 TUBE57 gHistorical