58368-002 NDC - NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS (TOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESS)

Drug Information

  • Product NDC: 58368-002
  • Proprietary Name: NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS
  • Non Proprietary Name: topical gel for muscle cramping and restlessness
  • Active Ingredient(s): 4 [hp_X]/g ARNICA MONTANA; 8 [hp_X]/g ARTEMISIA CINA PRE-FLOWERING TOP; 4 [hp_X]/g ATROPA BELLADONNA ROOT; 4 [hp_X]/g BLACK COHOSH; 4 [hp_X]/g CAUSTICUM; 4 [hp_X]/g FRANGULA CALIFORNICA BARK; 4 [hp_X]/g HYPERICUM PERFORATUM; 8 [hp_X]/g JATROPHA CURCAS SEED; 4 [hp_X]/g LYCOPODIUM CLAVATUM SPORE; 4 [hp_X]/g POTASSIUM BROMIDE; 4 [hp_X]/g POTASSIUM CARBONATE; 4 [hp_X]/g PSEUDOGNAPHALIUM OBTUSIFOLIUM; 4 [hp_X]/g RUTA GRAVEOLENS FLOWERING TOP; 4 [hp_X]/g SCUTELLARIA LATERIFLORA; 4 [hp_X]/g STRYCHNOS IGNATII SEED; 4 [hp_X]/g TARAXACUM OFFICINALE; 8 [hp_X]/g VALERIAN; 8 [hp_X]/g VERATRUM ALBUM ROOT
  • Administration Route(s): TOPICAL
  • Dosage Form(s): GEL

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
158368-002-0256.7 g in 1 BOTTLE, PUMP (58368-002-02)

NDC Record

Field Name Field Value Definition
PRODUCT NDC58368-002The 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 MUSCLE CRAMPLING AND RESTLESSNESSThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEtopical gel for muscle cramping and restlessnessThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEGELThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
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 NAMEARNICA MONTANA; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA ROOT; BLACK COHOSH; CAUSTICUM; FRANGULA CALIFORNICA BARK; HYPERICUM PERFORATUM; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; POTASSIUM BROMIDE; POTASSIUM CARBONATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; TARAXACUM OFFICINALE; VALERIAN; VERATRUM ALBUM ROOTAn 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; 8; 4; 4; 4; 4; 4; 8; 4; 4; 4; 4; 4; 4; 4; 4; 8; 8 
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 

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This page was last updated on: 7/4/2025

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