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  4. NDC Product Code: 83120-378 Secondary Numb Lidocaine Phenylephrine Gel

NDC 83120-378 Secondary Numb Lidocaine Phenylephrine Gel

Lidocaine,Phenylephrine Hydrochloride Gel Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 83120-378?
  4. Secondary Numb Lidocaine Phenylephrine Gel 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:
83120-378
Proprietary Name:
Secondary Numb Lidocaine Phenylephrine Gel
Non-Proprietary Name: [1]
Lidocaine, Phenylephrine Hydrochloride
Substance Name: [2]
Lidocaine; Phenylephrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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]
    Lalani Rx Consulting, Inc.
    Labeler Code:
    83120
    Product Label ID:
    0f13f7b5-e3b1-451e-a6d6-e7e15bd04443
    FDA Application Number: [6]
    M015
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    10-10-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 83120-378?

    The NDC code 83120-378 is assigned by the FDA to the product Secondary Numb Lidocaine Phenylephrine Gel which is a human over the counter drug product labeled by Lalani Rx Consulting, Inc.. The generic name of Secondary Numb Lidocaine Phenylephrine Gel is lidocaine, phenylephrine hydrochloride. The product's dosage form is gel and is administered via topical form. The product is distributed in a single package with assigned NDC code 83120-378-00 1 tube in 1 box / 31.18 g in 1 tube. 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 Secondary Numb Lidocaine Phenylephrine Gel?

    Adults and children 12 years and over: • Children under 12 consult a doctor • Cleanse the affected area with mild soap and warm water. Rinse well or pat with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying this product • Apply to the affected area up to 3 times daily • Do not use more often than directed

    What are Secondary Numb Lidocaine Phenylephrine Gel 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 50 mg/g - 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.
    • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/g - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.

    Which are Secondary Numb Lidocaine Phenylephrine Gel UNII Codes?

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

    Which are Secondary Numb Lidocaine Phenylephrine Gel 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 Secondary Numb Lidocaine Phenylephrine Gel?

    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: 2621576 - lidocaine 5 % / phenylephrine HCl 0.25 % Rectal Gel
    • RxCUI: 2621576 - lidocaine 0.05 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Gel
    • RxCUI: 2621576 - lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal Gel

    Which are the Pharmacologic Classes for Secondary Numb Lidocaine Phenylephrine Gel?

    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".