NDC 0067-8152 Voltaren Arthritis Pain

Diclofenac Sodium Gel Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0067-8152
Proprietary Name:
Voltaren Arthritis Pain
Non-Proprietary Name: [1]
Diclofenac Sodium
Substance Name: [2]
Diclofenac Sodium
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]
    Glaxosmithkline Consumer Healthcare Holdings (us) Llc
    Labeler Code:
    0067
    FDA Application Number: [6]
    NDA022122
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    05-13-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 0067-8152-01

    Package Description: 1 TUBE in 1 CARTON / 20 g in 1 TUBE

    NDC Code 0067-8152-02

    Package Description: 1 TUBE in 1 CARTON / 50 g in 1 TUBE

    NDC Code 0067-8152-03

    Package Description: 1 TUBE in 1 CARTON / 100 g in 1 TUBE

    NDC Code 0067-8152-04

    Package Description: 1 TUBE in 1 CARTON / 150 g in 1 TUBE

    NDC Code 0067-8152-08

    Package Description: 2 TUBE in 1 CARTON / 100 g in 1 TUBE

    NDC Code 0067-8152-09

    Package Description: 1 TUBE in 1 CARTON / 20 g in 1 TUBE

    Product Details

    What is NDC 0067-8152?

    The NDC code 0067-8152 is assigned by the FDA to the product Voltaren Arthritis Pain which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Voltaren Arthritis Pain is diclofenac sodium. The product's dosage form is gel and is administered via topical form. The product is distributed in 6 packages with assigned NDC codes 0067-8152-01 1 tube in 1 carton / 20 g in 1 tube, 0067-8152-02 1 tube in 1 carton / 50 g in 1 tube, 0067-8152-03 1 tube in 1 carton / 100 g in 1 tube, 0067-8152-04 1 tube in 1 carton / 150 g in 1 tube, 0067-8152-08 2 tube in 1 carton / 100 g in 1 tube, 0067-8152-09 1 tube in 1 carton / 20 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 Voltaren Arthritis Pain?

    See also Warning section. This medication is used to relieve joint pain from arthritis. Diclofenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain.

    What are Voltaren Arthritis Pain 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.
    • DICLOFENAC SODIUM 10 mg/g - A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.

    Which are Voltaren Arthritis Pain UNII Codes?

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

    Which are Voltaren Arthritis Pain 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 Voltaren Arthritis Pain?

    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:

    Which are the Pharmacologic Classes for Voltaren Arthritis Pain?

    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

    Diclofenac Topical (actinic keratosis)


    Diclofenac topical gel (Solaraze) is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). The way diclofenac gel works to treat actinic keratosis is not known. Diclofenac is also available as a liquid (Pennsaid) and a gel (Voltaren) that are applied to the skin to treat arthritis pain. This monograph only gives information about diclofenac gel (Solaraze) for actinic keratosis. If you are using either of the products for osteoarthritis, read the monograph entitled diclofenac topical (osteoarthritis pain).
    [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.

    [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".