Phexx lactic acid, L-, citric acid monohydrate, and potassium bitartrate 90 mg/5g; 50 mg/5g; 20 mg/5g Gel
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Organic acids class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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 viru...
Read the full MedlinePlus article ↗- You insert one pre-filled applicator vaginally right before sex — anywhere from right before up to one hour ahead of time. If you end up having sex more than once within that hour,...
- How exactly do I use Phexxi or Phexx, and how soon before sex do I need to apply it?
- Yes — Phexxi and Phexx are compatible with hormonal birth control methods, latex and polyurethane condoms, and diaphragms. The one thing to avoid is a vaginal ring. If you use a va...
- Can I use this along with my birth control pill, condoms, or a diaphragm?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $6.055 | $363.29 / 60 g |
| Medicaid paysCMS SDUD · 12 mo | $6.13 | $368.08 / 60 g |
| Medicare drug plans payPart D · Q2 2026 | $6.24 | $374.45 / 60 g |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Phexx 90 mg/5g; 50 mg/5g; 20 mg/5gthis 69751-0101-12 | Evofem, | 12 applicators | $6.055 | — | Availability likely | — |
| Phexxi 90 mg/5g; 50 mg/5g; 20 mg/5g 69751-0100-03 | Evofem, | 3 applicators | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11337989 ↗ | Method of use | U-1 | Mar 15, 2033 |
| US 11992472 ↗ | Method of use | U-1 | Mar 15, 2033 |
| US 10568855 ↗ | Method of use | U-1 | Mar 15, 2033 |
| US 11439610 ↗ | Drug substance | — | Mar 15, 2033 |
Is there a generic version of PHEXX 1.8-1-0.4% VAGINAL GEL?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
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What does “current Orange Book estimate” mean?
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69751-0101-12 You're viewing this | 12 APPLICATOR in 1 BOX (69751-101-12) / 5 g in 1 APPLICATOR (69751-101-01) | 2020-09-01 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE PHEXX is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. PHEXX is a combination of lactic acid, citric acid, and potassium bitartrate indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. ( 1 ) Limitations of Use: PHEXX is not effective for the prevention of pregnancy when administered after intercourse.
Limitations of Use PHEXX is not effective for the prevention of pregnancy when administered after intercourse [ see Dosage and Administration (2.1) ].
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administer one ( 1 ) pre-filled single-dose applicator of PHEXX (5 grams) vaginally immediately before (or up to one hour before) each episode of vaginal intercourse ( 2.1 ) May use during any part of the menstrual cycle ( 2.2 )
2.1Recommended Dosage Administer one pre-filled applicator of PHEXX (5 grams) vaginally immediately before or up to one hour before each act of vaginal intercourse. If more than one act of vaginal intercourse occurs within one hour, an additional dose must be applied. Five grams of PHEXX contains 90 mg of lactic acid, 50 mg of citric acid, and 20 mg of potassium bitartrate.
2.2Timing of PHEXX Use May use PHEXX during any part of the menstrual cycle. May use PHEXX as soon as it is safe to resume vaginal intercourse after childbirth, abortion, or miscarriage.
2.3Use of PHEXX with Other Contraceptive Methods PHEXX may be used concomitantly with hormonal contraceptives; latex, polyurethane, and polyisoprene condoms; and vaginal diaphragms. Avoid PHEXX use with vaginal rings.
2.4Use of PHEXX with Other Vaginal Products PHEXX may be used concomitantly with other products for vaginal infections including miconazole, metronidazole, and tioconazole.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Vaginal gel: 18 mg of lactic acid, 10 mg of citric acid, and 4 mg of potassium bitartrate in each gram (1.8%, 1%, and 0.4%, respectively) of off-white to tan color gel supplied in a pre-filled single-dose (5 grams) vaginal applicator Each pre-filled single-dose vaginal applicator delivers 5 grams of gel containing lactic acid (1.8%), citric acid (1%), and potassium bitartrate (0.4%). ( 3 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Cystitis and Pyelonephritis: Avoid use in women with a history of recurrent UTI or urinary tract abnormalities ( 5.1 )
5.1Cystitis and Pyelonephritis Among 2804 subjects who received PHEXX in Studies 1 and 2, 0.36% (n=10) reported adverse reactions of cystitis, pyelonephritis, or other upper urinary tract infection (UTI). Of these, one case of pyelonephritis was considered serious and required hospitalization. Avoid use of PHEXX in females of reproductive potential with a history of recurrent urinary tract infection or urinary tract abnormalities.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cystitis and Pyelonephritis [ see Warnings and Precautions (5.1) ] Most common adverse reactions (≥2%) were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free phone 1-833-EVFMBIO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PHEXX (pre-filled applicator with 5-gram dose) has been evaluated in two clinical trials (Study 1 and Study 2) in 2804 subjects (over 19,000 cycles of exposure). The racial/ethnic distribution was 66% White, 27% Black or African American, 2% Asian, 1% American Indian or Alaska Native, 0.3% Native Hawaiian or Pacific Islander, and 5% other; 32% of the study population was Hispanic.
Study 1 included a one-year extension phase where 342 U.S. subjects were exposed to PHEXX for 13 cycles. Hypersensitivity Reaction Of the 2804 PHEXX-treated subjects in Studies 1 and 2, one subject reported a suspected drug hypersensitivity. Avoid PHEXX use in females of reproductive potential with suspected hypersensitivity to the ingredients in PHEXX.
The most common adverse reactions (≥10%) in the U.S. population in Studies 1 and 2 (n=2480) were: vulvovaginal burning sensation (18.0%) and vulvovaginal pruritus (14.5%). The majority of these adverse reactions were mild and few led to discontinuation. Table 1 summarizes the most common adverse reactions (≥2%) reported by subjects using PHEXX in the U.S.
Table 1. Adverse Reactions that Occurred in ≥2% of Subjects Who Used PHEXX to Prevent Pregnancy (Studies 1 and 2 – U.S. population only) Adverse Reaction PHEXX (N=2480) (%) Vulvovaginal Burning Sensation
18.0 Vulvovaginal Pruritus
14.5Vulvovaginal Mycotic Infection Includes preferred terms (PT) vulvovaginal mycotic infection and vulvovaginal candidiasis.
9.1Urinary Tract Infection Includes PTs urinary tract infection, streptococcal urinary tract infection, Escherichia urinary tract infection, and urinary tract infection bacterial. Does not include PTs cystitis, kidney infection, and pyelonephritis [ see Warnings and Precautions (5.1) ].
9.0 Vulvovaginal Discomfort
9.0 Bacterial Vaginosis
8.4 Vaginal Discharge
5.5 Genital Discomfort
4.1 Dysuria
3.1 Vulvovaginal Pain
2.1Among subjects who used PHEXX in Studies 1 and 2, 1.6% discontinued from the clinical trials due to an adverse reaction. The most common adverse reactions leading to study discontinuation were vulvovaginal burning sensation (0.7%); and vulvovaginal pruritus and vulvovaginal discomfort (0.1% each). Adverse Reactions in Male Partners Among male partners of subjects who used PHEXX for contraception in Study 2, 9.8% (131 of 1330) reported symptoms of local discomfort (burning, itching, pain, and "other").
Of these local discomfort symptoms, 74.7% were mild, 21.4% were moderate, and 3.9% were severe. Two subjects discontinued participation in the study due to male partner symptoms.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There is no use for PHEXX in pregnancy; therefore, discontinue PHEXX during pregnancy. There are no data with the use of PHEXX in pregnant women or animals. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
8.2Lactation Risk Summary There are no data on the presence of lactic acid, citric acid, and potassium bitartrate or their metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
8.4Pediatric Use The safety and effectiveness of PHEXX have been established in females of reproductive potential. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for users 17 years and older. The use of PHEXX before menarche is not indicated.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There is no use for PHEXX in pregnancy; therefore, discontinue PHEXX during pregnancy. There are no data with the use of PHEXX in pregnant women or animals. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of PHEXX have been established in females of reproductive potential. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for users 17 years and older. The use of PHEXX before menarche is not indicated.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action In in vitro studies, PHEXX produced a normal vaginal pH range (pH 3.5 – 4.5) in the presence of semen. In clinical studies, post-coital testing demonstrated pH <5 in the majority of subjects, and sperm motility reduction.
12.2Pharmacodynamics Pharmacodynamic studies in humans have not been performed.
12.3Pharmacokinetics Pharmacokinetic studies in humans have not been performed. Systemic exposures of lactic acid, citric acid, and potassium bitartrate following vaginal administration of PHEXX are not expected to lead to safety concerns. In vitro studies with commonly used vaginal preparations (miconazole, metronidazole, tioconazole, and a product for maintaining normal vaginal pH) showed no significant effect on the pH or buffering capacity of PHEXX.
🧬 Mechanism of Action ▾
12.1Mechanism of Action In in vitro studies, PHEXX produced a normal vaginal pH range (pH 3.5 – 4.5) in the presence of semen. In clinical studies, post-coital testing demonstrated pH <5 in the majority of subjects, and sperm motility reduction.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING PHEXX (lactic acid, citric acid, and potassium bitartrate) vaginal gel is an off-white to tan color gel of uniform consistency containing lactic acid (1.8%), citric acid (1%), and potassium bitartrate (0.4%), supplied as individually wrapped 5 gram pre-filled single-dose vaginal applicators in sealed foil pouches along with a plunger, and are available as follows: NDC 69751-101-12 Box of 12 units Store in the original foil pack at room temperature 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) [ see USP Controlled Room Temperature ].
📦 Storage and Handling ▾
Store in the original foil pack at room temperature 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) [ see USP Controlled Room Temperature ].
📋 Description ▾
11 DESCRIPTION PHEXX (lactic acid, citric acid, and potassium bitartrate) is a vaginal gel. PHEXX is an off-white to tan in color gel of uniform consistency, containing three active ingredients: lactic acid, citric acid, and potassium bitartrate. The structural formula for lactic acid is: Lactic acid is designated chemically as 2-hydroxypropanoic acid with an empirical formula of C 3 H 6 O 3 and a molecular weight of 90.08 g/mol.
The structural formula for citric acid is: Citric acid is designated chemically as 2-hydroxypropane-1,2,3-tricarboxylic acid with an empirical formula of C 6 H 8 O 7 and a molecular weight of 192.124 g/mol. The structural formula for potassium bitartrate is: Potassium bitartrate is designated chemically as potassium; (2 R , 3 R )-2,3,4-trihydroxy-4-oxobutanoate with an empirical formula of KC 4 H 5 O 6 and a molecular weight of 188.177 g/mol. Each 5 gram dose is provided in a pre-filled single-dose applicator containing lactic acid USP (1.8% w/w), citric acid USP (1% w/w), and potassium bitartrate USP (0.4% w/w).
Inactive ingredients present in the gel are: glycerin, alginic acid, xanthan gum, sodium hydroxide, benzoic acid, and purified water. Chemical Structure Chemical Structure Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the Patient Information and FDA-approved patient labeling (Instructions for Use). Advise the patient: To intravaginally administer the contents of one pre-filled single-dose applicator of PHEXX before each episode of vaginal intercourse and to administer an additional dose if intercourse does not occur within one hour of administration [ see Dosage and Administration (2.1) ]. To consult their healthcare provider for severe or prolonged genital irritation [ see Adverse Reactions (6.1) ].
To discontinue PHEXX if they develop a local hypersensitivity reaction [ see Adverse Reactions (6.1) ]. To contact their healthcare provider if experiencing urinary tract symptoms [ see Warnings and Precautions (5.1) ]. That PHEXX does not protect against HIV infection and other sexually transmitted infections.