Phexxi Gel
NDC 69751-100

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69751-100?
  5. Phexxi Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Phexxi (lactic acid, l-, citric acid monohydrate, and potassium bitartrate) is a NDA-approved product labeled by Evofem, Inc.. This medication is typically used as a acidifying activity [moa]. It is supplied as a white gel for vaginal administration. This product entry covers the primary NDC 69751-100 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
69751-100
Proprietary Name:
Phexxi
Non-Proprietary Name: [1]
Lactic Acid, L-, Citric Acid Monohydrate, And Potassium Bitartrate
Substance Name: [2]
Citric Acid Monohydrate; Lactic Acid, L-; Potassium Bitartrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

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]
Vaginal - Administration into the vagina.

Labeler & Regulatory Data

Labeler Name: [5]
Evofem, Inc.
Labeler Code:
69751
Product Label ID:
173ff411-7227-47b0-94dc-844e1ebaf14e
FDA Application Number: [6]
NDA208352
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
08-01-2020
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - OFF-WHITE TO TAN)

Code Structure Chart

Product Details

What is NDC 69751-100?

The NDC code 69751-100 is assigned by the FDA to the product Phexxi. It is commonly known by its generic name, lactic acid, l-, citric acid monohydrate, and potassium bitartrate. This pharmaceutical product is labeled by Evofem, Inc. and is currently categorized as listed product. The medication is a gel administered via vaginal route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 69751-100-03, 69751-100-12. 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?

PHEXXI is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

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.

Which are the associated UNII Codes?

The UNII codes for the active 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: 2385348 - lactic acid 1.8 % / citric acid 1 % / potassium bitartrate 0.4 % Vaginal Gel
  • RxCUI: 2385348 - citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / potassium bitartrate 0.004 MG/MG Vaginal Gel
  • RxCUI: 2385348 - citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / K+ bitartrate 0.004 MG/MG Vaginal Gel
  • RxCUI: 2385348 - citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / Pot bitartrate 0.004 MG/MG Vaginal Gel
  • RxCUI: 2385353 - PHEXXI 1.8 % / 1 % / 0.4 % Vaginal Gel

Which are the Pharmacologic Classes of this product?

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.

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Patient Education

Lactic Acid, Citric Acid, and Potassium Bitartrate Vaginal Contraceptive


The combination of lactic acid, citric acid, and potassium bitartrate is used to prevent pregnancy when used just before vaginal sex in women who can become pregnant. It does not prevent pregnancy when used after vaginal sex. The combination of lactic acid, citric acid, and potassium bitartrate is in a class of medications called non-hormonal contraceptives. It works by lowering the pH of the vagina and reducing sperm motility. Lactic acid, citric acid, and potassium bitartrate may prevent pregnancy, but this medication will not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
[Learn More]


* 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 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.
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 Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
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".