NDC 81923-199 Skins Delay Maximum Strength Lidocaine

Lidocaine Hydrochloride Solution Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
81923-199
Proprietary Name:
Skins Delay Maximum Strength Lidocaine
Non-Proprietary Name: [1]
Lidocaine Hydrochloride
Substance Name: [2]
Lidocaine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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]
    Skins Sexual Health Limited
    Labeler Code:
    81923
    FDA Application Number: [6]
    M017
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    05-25-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 81923-199-00

    Package Description: 1 CYLINDER in 1 BOX / 15 mL in 1 CYLINDER

    Product Details

    What is NDC 81923-199?

    The NDC code 81923-199 is assigned by the FDA to the product Skins Delay Maximum Strength Lidocaine which is a human over the counter drug product labeled by Skins Sexual Health Limited. The generic name of Skins Delay Maximum Strength Lidocaine is lidocaine hydrochloride. The product's dosage form is solution and is administered via topical form. The product is distributed in a single package with assigned NDC code 81923-199-00 1 cylinder in 1 box / 15 ml in 1 cylinder. 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 Skins Delay Maximum Strength Lidocaine?

    Apply 3 or more sprays to the head and shaft of the penis depending on the level of anaesthesia desired. Do not exceed 10 sprays. Massage into the penis for around twenty seconds or until optimal absorption is reached. Wash hands thoroughly after use. You will feel the product start to work after 3-5 minutes so although you can apply up to 10 sprays we recommend waiting to feel the full effects before applying any more. You should always use minimum effective quantity.

    What are Skins Delay Maximum Strength Lidocaine 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.
    • LIDOCAINE HYDROCHLORIDE 10 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 Skins Delay Maximum Strength Lidocaine UNII Codes?

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

    Which are Skins Delay Maximum Strength Lidocaine 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:

    Which are the Pharmacologic Classes for Skins Delay Maximum Strength Lidocaine?

    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".