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  4. NDC Product Code: 51316-225 Hemorrhoidal With Lidocaine

NDC 51316-225 Hemorrhoidal With Lidocaine

Glycerin,Lidocaine,Phenylephrine Hydrochloride,White Petrolatum Cream Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 51316-225?
  4. Hemorrhoidal With Lidocaine 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:
51316-225
Proprietary Name:
Hemorrhoidal With Lidocaine
Non-Proprietary Name: [1]
Glycerin, Lidocaine, Phenylephrine Hydrochloride, White Petrolatum
Substance Name: [2]
Glycerin; Lidocaine; Phenylephrine Hydrochloride; White Petrolatum
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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]
    Cvs Pharmacy, Inc
    Labeler Code:
    51316
    Product Label ID:
    4d870c68-9e72-464e-b0b8-900d0d661e43
    FDA Application Number: [6]
    M016
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    06-01-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 51316-225-00

    Package Description: 1 TUBE in 1 BOX / 28 g in 1 TUBE

    Product Details

    What is NDC 51316-225?

    The NDC code 51316-225 is assigned by the FDA to the product Hemorrhoidal With Lidocaine which is a human over the counter drug product labeled by Cvs Pharmacy, Inc. The generic name of Hemorrhoidal With Lidocaine is glycerin, lidocaine, phenylephrine hydrochloride, white petrolatum. The product's dosage form is cream and is administered via topical form. The product is distributed in a single package with assigned NDC code 51316-225-00 1 tube in 1 box / 28 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 Hemorrhoidal With Lidocaine?

    Adults:when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying this cream.apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementchildren under 12 years of age: ask a doctor.

    What are Hemorrhoidal With 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.
    • GLYCERIN 144 mg/g
    • 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.
    • WHITE PETROLATUM 150 mg/g - A colloidal system of semisolid hydrocarbons obtained from PETROLEUM. It is used as an ointment base, topical protectant, and lubricant.

    Which are Hemorrhoidal With Lidocaine UNII Codes?

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

    Which are Hemorrhoidal With 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:

    What is the NDC to RxNorm Crosswalk for Hemorrhoidal With Lidocaine?

    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: 2642220 - glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal Cream
    • RxCUI: 2642220 - glycerin 144 MG/ML / lidocaine 50 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream

    Which are the Pharmacologic Classes for Hemorrhoidal With 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".