Anodyne Pain Relief

Actaea, Belladonna, Bryonia, Cimicifuga, Ledum, Rhododendron, Ruga Grav, Arnica, Salicylicum Ac, Bellis, Hypericum

Biolyte Laboratories, Llc
Human Otc Drug
NDC 58368-020

Anodyne Pain Relief also known as Actaea, Belladonna, Bryonia, Cimicifuga, Ledum, Rhododendron, Ruga Grav, Arnica, Salicylicum Ac, Bellis, Hypericum is a human otc drug labeled by 'Biolyte Laboratories, Llc'. National Drug Code (NDC) number for Anodyne Pain Relief is 58368-020. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Anodyne Pain Relief drug includes Actaea Spicata Root - 3 [hp_X]/g Arnica Montana - 3 [hp_X]/g Atropa Belladonna Root - 3 [hp_X]/g Bellis Perennis - 3 [hp_X]/g Black Cohosh - 3 [hp_X]/g Bryonia Alba Root - 3 [hp_X]/g Hypericum Perforatum - 3 [hp_X]/g Ledum Palustre Twig - 3 [hp_X]/g Rhododendron Aureum Leaf - 3 [hp_X]/g Ruta Graveolens Flowering Top - 3 [hp_X]/g and more. The currest status of Anodyne Pain Relief drug is Active.

Drug Information:

Drug NDC:	58368-020
The 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.
Proprietary Name:	Anodyne Pain Relief
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Actaea, Belladonna, Bryonia, Cimicifuga, Ledum, Rhododendron, Ruga Grav, Arnica, Salicylicum Ac, Bellis, Hypericum
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Biolyte Laboratories, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Cream
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ACTAEA SPICATA ROOT - 3 [hp_X]/g ARNICA MONTANA - 3 [hp_X]/g ATROPA BELLADONNA ROOT - 3 [hp_X]/g BELLIS PERENNIS - 3 [hp_X]/g BLACK COHOSH - 3 [hp_X]/g BRYONIA ALBA ROOT - 3 [hp_X]/g HYPERICUM PERFORATUM - 3 [hp_X]/g LEDUM PALUSTRE TWIG - 3 [hp_X]/g RHODODENDRON AUREUM LEAF - 3 [hp_X]/g RUTA GRAVEOLENS FLOWERING TOP - 3 [hp_X]/g Load more... SALICYLIC ACID - 3 [hp_X]/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	16 Nov, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	24 Jun, 2026
This 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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	BioLyte Laboratories, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	3FU86L9OS0 O80TY208ZW 6MW97Q6E8M 2HU33I03UY K73E24S6X9 T7J046YI2B XK4IUX8MNB 877L01IZ0P IV92NQJ73U N94C2U587S Load more... O414PZ4LPZ
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
58368-020-01	56.7 g in 1 BOTTLE, PUMP (58368-020-01)	16 Nov, 2020	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Anodyne Pain Relief

Actaea & more..

Cream
BioLyte Laboratories, LLC
NDC: 58368-020

Purpose:

Purpose all active ingredients are hpus* & 3x potency. actaea, belladonna, bryonia, cimicifuga, ledum, rhododendron, ruta grav. ............................topical analgesics arnica, salicylicum ac. ...........................anti-inflammatory bellis, hypercium .........................relief of brusing and soreness *hpus indicates the active ingredients are in the official homeopathic pharmacopeia of the united states.

Product Elements:

Anodyne pain relief actaea, belladonna, bryonia, cimicifuga, ledum, rhododendron, ruga grav, arnica, salicylicum ac, bellis, hypericum carbomer homopolymer type c cannabidiol arnica montana arnica montana black cohosh black cohosh rhododendron aureum leaf rhododendron aureum leaf salicylic acid salicylic acid atropa belladonna root atropa belladonna root ledum palustre twig ledum palustre twig actaea spicata root actaea spicata root bellis perennis bellis perennis hypericum perforatum hypericum perforatum ruta graveolens flowering top ruta graveolens flowering top bryonia alba root bryonia alba root caprylyl glycol anhydrous citric acid sodium hydroxide water

Indications and Usage:

Uses for temporary releif of occasional: minor aches and pains stiffness of muscles, joints and tissues. indications are based on homeopathic materia medica, not clinical tests.

Warnings:

Warnings for external use only. do not use on damaged or broken skin. with other topical remedies or lotions. keep out of eyes open wounds mucous membranes. stop use and ask doctor if condition worsens or persists rash develops ask a doctor before use if you are taking a prescription drug or have a serious medical condition. if pregnant or breastfeeding consult your doctor before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Do Not Use:

Dosage and Administration:

Directions adults and children 2 years of age and older, liberally apply gel on clean skin to cover the affected area. for best results, allow gel to be absorbed into the skin; do not rub in. apply at the onset of symptoms, not more than 6 times daily or every 15 minutes for the first hour.

Stop Use:

Stop use and ask doctor if condition worsens or persists rash develops

Package Label Principal Display Panel:

Package display panel 1 anodyne pain relief cream panel 1 package display panel 2 package display panel 2 package display panel 3 package display panel 3

Package display panel 2 package display panel 2

Package display panel 3 package display panel 3

Further Questions:

Questions or comments? report serious side effects to 800.252.2056 monday through friday, 8 a.m. - 5 p.m. pst or visit us at novopurecbd.com

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.