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  4. NDC Product Code: 65121-209 Biochemistry Pain Relief Foot Active

NDC 65121-209 Biochemistry Pain Relief Foot Active

Benzyl Alcohol,Lidocaine Hydrochloride Liquid Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 65121-209?
  4. Biochemistry Pain Relief Foot Active Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
65121-209
Proprietary Name:
Biochemistry Pain Relief Foot Active
Non-Proprietary Name: [1]
Benzyl Alcohol, Lidocaine Hydrochloride
Substance Name: [2]
Benzyl Alcohol; Lidocaine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Pure Source, Llc
    Labeler Code:
    65121
    Product Label ID:
    2b526c02-e7fe-49f6-a7bb-7ec33804bfa4
    FDA Application Number: [6]
    M017
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    02-06-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 65121-209-31

    Package Description: 1 BOTTLE, SPRAY in 1 CARTON / 30 mL in 1 BOTTLE, SPRAY

    NDC Code 65121-209-32

    Package Description: 1 BOTTLE, SPRAY in 1 CARTON / 60 mL in 1 BOTTLE, SPRAY

    Product Details

    What is NDC 65121-209?

    The NDC code 65121-209 is assigned by the FDA to the product Biochemistry Pain Relief Foot Active which is a human over the counter drug product labeled by Pure Source, Llc. The generic name of Biochemistry Pain Relief Foot Active is benzyl alcohol, lidocaine hydrochloride. The product's dosage form is liquid and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 65121-209-31 1 bottle, spray in 1 carton / 30 ml in 1 bottle, spray, 65121-209-32 1 bottle, spray in 1 carton / 60 ml in 1 bottle, spray. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Biochemistry Pain Relief Foot Active?

    Over 12-yearsApply directly to affected areaDo not wrap affected areaDo not use more than four times per day

    What are Biochemistry Pain Relief Foot Active Active Ingredients?

    An 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.
    • BENZYL ALCOHOL 190 mg/mL - A colorless liquid with a sharp burning taste and slight odor. It is used as a local anesthetic and to reduce pain associated with LIDOCAINE injection. Also, it is used in the manufacture of other benzyl compounds, as a pharmaceutic aid, and in perfumery and flavoring.
    • LIDOCAINE HYDROCHLORIDE 40 mg/mL - A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.

    Which are Biochemistry Pain Relief Foot Active UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Biochemistry Pain Relief Foot Active Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Biochemistry Pain Relief Foot Active?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1488328 - benzyl alcohol 19 % / lidocaine HCl 4 % Topical Spray
    • RxCUI: 1488328 - benzyl alcohol 0.19 ML/ML / lidocaine hydrochloride 40 MG/ML Topical Spray
    • RxCUI: 1488328 - benzyl alcohol 19 % / lidocaine hydrochloride 4 % Topical Spray
    • RxCUI: 1488333 - biochemistry Heel No Pain 19 % / 4 % Topical Spray
    • RxCUI: 1488333 - benzyl alcohol 0.19 ML/ML / lidocaine hydrochloride 40 MG/ML Topical Spray [Biochemistry Heel No Pain]

    Which are the Pharmacologic Classes for Biochemistry Pain Relief Foot Active?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An 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.

    [3] What kind of product is this? - Indicates 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".