58368-005 NDC - NEORELIEF FOR PAIN (TOPICAL GEL FOR PAIN)

Drug Information

  • Product NDC: 58368-005
  • Proprietary Name: NEORELIEF FOR PAIN
  • Non Proprietary Name: topical gel for pain
  • Active Ingredient(s): 4 [hp_X]/g ACTAEA SPICATA ROOT; 4 [hp_X]/g ALTHAEA OFFICINALIS ROOT; 4 [hp_X]/g ARNICA MONTANA; 4 [hp_X]/g ATROPA BELLADONNA ROOT; 4 [hp_X]/g BELLIS PERENNIS; 4 [hp_X]/g BLACK COHOSH; 4 [hp_X]/g BRYONIA ALBA ROOT; 4 [hp_X]/g CALENDULA OFFICINALIS FLOWERING TOP; 4 [hp_X]/g CAULOPHYLLUM THALICTROIDES ROOT; 4 [hp_X]/g CAUSTICUM; 4 [hp_X]/g FRANGULA CALIFORNICA BARK; 4 [hp_X]/g GUAIACUM OFFICINALE RESIN; 4 [hp_X]/g HORSE CHESTNUT; 4 [hp_X]/g HYPERICUM PERFORATUM; 4 [hp_X]/g LEDUM PALUSTRE TWIG; 4 [hp_X]/g LITHIUM CARBONATE; 4 [hp_X]/g POTASSIUM CARBONATE; 4 [hp_X]/g RHODODENDRON AUREUM LEAF; 4 [hp_X]/g RUTA GRAVEOLENS FLOWERING TOP; 4 [hp_X]/g SALICYLIC ACID; 4 [hp_X]/g STELLARIA MEDIA; 4 [hp_X]/g TOXICODENDRON PUBESCENS LEAF
  • Administration Route(s): TOPICAL
  • Dosage Form(s): GEL
  • Pharmacy Class(es): Mood Stabilizer [EPC]

Labeler Information

Field Name Field Value
Labeler Name: BioLyte Laboratories, LLC
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:2/1/2017

Package Information

No. Package Code Package Description Billing Unit
158368-005-011 BOTTLE, PUMP in 1 CARTON (58368-005-01) / 56.7 g in 1 BOTTLE, PUMP

NDC Record

Field Name Field Value Definition
PRODUCT NDC58368-005The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMENEORELIEF FOR PAINThis is the date that the labeler indicates was the start of its marketing of the drug product.
NON PROPRIETARY NAMEtopical gel for painThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
DOSAGE FORM NAMEGELProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ROUTE NAMETOPICALName of Company corresponding to the labeler code segment of the Product NDC.
START MARKETING DATE2/1/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEBioLyte Laboratories, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACTAEA SPICATA ROOT; ALTHAEA OFFICINALIS ROOT; ARNICA MONTANA; ATROPA BELLADONNA ROOT; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; FRANGULA CALIFORNICA BARK; GUAIACUM OFFICINALE RESIN; HORSE CHESTNUT; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; POTASSIUM CARBONATE; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; STELLARIA MEDIA; TOXICODENDRON PUBESCENS LEAFAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4 
ACTIVE INGRED UNIT[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 
PHARM CLASSESMood Stabilizer [EPC] 

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This page was last updated on: 12/19/2025

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