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NDC 0813-0799 Fem Ph

Acetic Acid And Oxyquinoline Sulfate Jelly Vaginal - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0813-0799?
  5. Fem Ph Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
0813-0799
Proprietary Name:
Fem Ph
Non-Proprietary Name: [1]
Acetic Acid And Oxyquinoline Sulfate
Substance Name: [2]
Acetic Acid; Oxyquinoline Sulfate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Jelly - A class of gels, which are semisolid systems that consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water.
Administration Route(s): [4]
  • Vaginal - Administration into the vagina.
    • Labeler Name: [5]
    Pharmics, Inc.
    Labeler Code:
    0813
    Product Label ID:
    77237c50-aeb5-44a0-a1e6-ce1551b49f75
    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]
    07-15-1999
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)

    Code Structure Chart

    Product Details

    What is NDC 0813-0799?

    The NDC code 0813-0799 is assigned by the FDA to the product Fem Ph which is a human prescription drug product labeled by Pharmics, Inc.. The generic name of Fem Ph is acetic acid and oxyquinoline sulfate. The product's dosage form is jelly and is administered via vaginal form. The product is distributed in a single package with assigned NDC code 0813-0799-55 50 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 Fem Ph?

    Fem pH is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.

    What are Fem Ph 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.
    • ACETIC ACID .009 g/g - Product of the oxidation of ethanol and of the destructive distillation of wood. It is used locally, occasionally internally, as a counterirritant and also as a reagent. (Stedman, 26th ed)
    • OXYQUINOLINE SULFATE .00025 g/g - An antiseptic with mild fungistatic, bacteriostatic, anthelmintic, and amebicidal action. It is also used as a reagent and metal chelator, as a carrier for radio-indium for diagnostic purposes, and its halogenated derivatives are used in addition as topical anti-infective agents and oral antiamebics.

    Which are Fem Ph UNII Codes?

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

    Which are Fem Ph 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 Fem Ph?

    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: 1243480 - fem pH 0.9 % / 0.025 % Vaginal Gel
    • RxCUI: 1243480 - acetic acid 0.009 MG/MG / oxyquinoline sulfate 0.00025 MG/MG Vaginal Gel [Fem pH]
    • RxCUI: 1243480 - Fem pH (acetic acid 0.9 % / oxyquinoline sulfate 0.025 % ) Vaginal Gel
    • RxCUI: 543873 - acetic acid 0.9 % / oxyquinoline sulfate 0.025 % Vaginal Gel
    • RxCUI: 543873 - acetic acid 0.009 MG/MG / oxyquinoline sulfate 0.00025 MG/MG Vaginal Gel

    * 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".