Trimo San Jelly
NDC 59365-5030

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 59365-5030?
  4. Trimo San Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

Trimo San (oxyquinoline sulfate and sodium lauryl sulfate) is a UNAPPROVED DRUG OTHER-approved product labeled by Coopersurgical, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a jelly for vaginal administration. This product entry covers the primary NDC 59365-5030 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
59365-5030
Proprietary Name:
Trimo San
Non-Proprietary Name: [1]
Oxyquinoline Sulfate And Sodium Lauryl Sulfate
Substance Name: [2]
Oxyquinoline Sulfate; Sodium Lauryl Sulfate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Coopersurgical, Inc.
Labeler Code:
59365
Product Label ID:
1e4a1caa-e6ba-44ef-8347-07e6385a7c9e
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
04-01-1977
End Marketing Date: [10]
10-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 59365-5030?

The NDC code 59365-5030 is assigned by the FDA to the product Trimo San. It is commonly known by its generic name, oxyquinoline sulfate and sodium lauryl sulfate. This pharmaceutical product is labeled by Coopersurgical, Inc. and is currently categorized as listed product. The medication is a jelly administered via vaginal route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 59365-5030-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This product is used as To help restore and maintain normal vaginal acidity.To coat walls of vagina with a lubricating film that helps reduce odor-causing bacteria.

What are Active Ingredients of this product?

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.
  • OXYQUINOLINE SULFATE .25 mg/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.
  • SODIUM LAURYL SULFATE .1 mg/g

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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: 999638 - oxyquinoline sulfate 0.025 % / sodium lauryl sulfate 0.01 % Vaginal Gel
  • RxCUI: 999638 - oxyquinoline sulfate 0.00025 MG/MG / sodium dodecyl sulfate 0.0001 MG/MG Vaginal Gel
  • RxCUI: 999640 - TRIMO-SAN 0.025 % / 0.01 % Vaginal Gel
  • RxCUI: 999640 - oxyquinoline sulfate 0.00025 MG/MG / sodium dodecyl sulfate 0.0001 MG/MG Vaginal Gel [Trimo San]
  • RxCUI: 999640 - Trimo San (oxyquinoline sulfate 0.025 % / sodium lauryl sulfate 0.01 % ) Vaginal Gel

* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".