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NDC 11086-032 Vanoxide HC

Benzoyl Peroxide,Hydrocortisone Lotion Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 11086-032?
  4. Vanoxide HC Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Pharmacologic Classes
  9. Patient Education

Product Information

NDC Product Code:
11086-032
Proprietary Name:
Vanoxide HC
Non-Proprietary Name: [1]
Benzoyl Peroxide, Hydrocortisone
Substance Name: [2]
Benzoyl Peroxide; Hydrocortisone
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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]
    Summers Laboratories Inc
    Labeler Code:
    11086
    Product Label ID:
    1f0edbd9-103e-4a49-b7a8-6552ef172c13
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    11-01-2009
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 11086-032?

    The NDC code 11086-032 is assigned by the FDA to the product Vanoxide HC which is a human prescription drug product labeled by Summers Laboratories Inc. The generic name of Vanoxide HC is benzoyl peroxide, hydrocortisone. The product's dosage form is lotion and is administered via topical form. The product is distributed in a single package with assigned NDC code 11086-032-01 25 g in 1 bottle . 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 Vanoxide HC?

    Keep away from eyes. FOR TOPICAL USE ONLY.Not for ophthalmic, oral or intravaginal use.Shake well before using.Keep tightly closed.Store at room temperature. 20°-25° C (68°-77° F). Do not freeze.

    What are Vanoxide HC 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.
    • BENZOYL PEROXIDE 5 g/100g - A peroxide derivative that has been used topically for BURNS and as a dermatologic agent in the treatment of ACNE and POISON IVY DERMATITIS. It is used also as a bleach in the food industry.
    • HYDROCORTISONE .5 g/100g - The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.

    Which are Vanoxide HC UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Vanoxide HC?

    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: 211765 - Vanoxide-HC (benzoyl peroxide 5 % / hydrocortisone 0.5 % ) Topical Lotion
    • RxCUI: 211765 - benzoyl peroxide 50 MG/ML / hydrocortisone 5 MG/ML Topical Lotion [Vanoxide-HC]
    • RxCUI: 244382 - benzoyl peroxide 5 % / hydrocortisone 0.5 % Topical Lotion
    • RxCUI: 244382 - benzoyl peroxide 50 MG/ML / hydrocortisone 5 MG/ML Topical Lotion

    Which are the Pharmacologic Classes for Vanoxide HC?

    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.

    Patient Education

    Benzoyl Peroxide Topical


    Benzoyl peroxide is used to treat mild to moderate acne.
    [Learn More]


    Hydrocortisone Topical


    Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
    [Learn More]


    * 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.

    [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".