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Phexx lactic acid, L-, citric acid monohydrate, and potassium bitartrate 90 mg/5g; 50 mg/5g; 20 mg/5g Gel — NDC 69751-101-12 (Billing 69751-0101-12)

by Evofem, Inc. · 12 APPLICATOR in 1 BOX / 5 g in 1 APPLICATOR

This is a package of Phexx lactic acid, L-, citric acid monohydrate, and potassium bitartrate 90 mg/5g; 50 mg/5g; 20 mg/5g Gel from Evofem, Inc., marketed since Aug 2020 and currently FDA-listed; retail pharmacies pay about $6.05 per g (NADAC). It is this product's only package size.

NDC 69751-0101-12
🏷️ FDA NDC (as labeled) 69751-101-12 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 69751-101-12 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69751 labeler · 101 product · 12 package
Package marketed since
Sep 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6975110112 2
Medicaid fills, this package
2,841 prescriptions in the last four reported quarters
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69751-101-12
Product NDC 69751-101
11-digit billing NDC 69751010112
NCPDP billing unit GM — per gram (weight)
RxCUI 2385348, 2700386
UNII F9S9FFU82N, 2968PHW8QP, NPT6P8P3UU
Application # NDA208352
SPL Set ID 14b01a15-9b47-4be3-bb2e-a2010eab429e
Established class (EPC) Anti-coagulant; Calculi Dissolution Agent
Mechanism of action Acidifying Activity; Calcium Chelating Activity
Physiologic effect Decreased Coagulation Factor Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-08-01
Route VAGINAL
Dosage form GEL
Substance LACTIC ACID, L-; CITRIC ACID MONOHYDRATE; POTASSIUM BITARTRATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 55329903404020
GCN Seq No 081105
GCN 48142
HICL code 046568
Ingredient (HICL) Lactic Acid/Citric/Potassium
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G9
Therapeutic class — intermediate (HIC2) Intravaginal Antifertility Agents
HIC3 code G9A
Therapeutic class — specific (HIC3) Contraceptives,Intravaginal
AHFS code 32:00.00.00
AHFS class Nonhormonal Contraceptives
FDB label name PHEXX 1.8-1-0.4% VAGINAL GEL
FDB brand name Phexx
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 081105
  • GCN: 48142
  • GPI-14 (Medi-Span): 55329903404020
  • HICL (First Databank): 046568
  • AHFS class code: 32:00.00.00
  • RxCUI (RxNorm): 2385348
Why two NDCs? The FDA registers this code as 69751-101-12 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 69751-0101-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Organic acids class.

Drug family (ATC) Organic acids
How it works Acidifying Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PHEXX 1.8-1-0.4% VAGINAL GEL Ingredient Lactic Acid/Citric/Potassium
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • No, it's not a pill. Both Phexxi and Phexx come as a pre-filled vaginal applicator, similar to how some yeast infection treatments work. You insert one applicator vaginally right b...
  • How exactly do I use Phexxi or Phexx — do I take it like a pill?
  • The FDA label for Phexxi and Phexx covers only pregnancy prevention — there is no indication that these products protect against sexually transmitted infections. If STI protection...
  • Does it protect against STIs (sexually transmitted infections)?
📖 Read our full Citric Acid / Lactic Acid / Potassium Bitartrate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer gPer package
Retail pharmacies payNADAC · weekly $6.054 $363.25 / 60 g
Medicaid paysCMS SDUD · 12 mo $6.19 $371.65 / 60 g
Medicare drug plans payPart D · Q2 2026 $6.24 $374.45 / 60 g
NADAC price history (per g) — tap or hover for the price & month
Jan 2026 May 2026 Jul 2026 Sep 2026 $6.071 $6.052
Flat over the last 6 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69751-0101-12 You're viewing this Main listing 12 APPLICATOR in 1 BOX / 5 g in 1 APPLICATOR 2020-09-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phexx 90 mg/5g; 50 mg/5g; 20 mg/5gthis 69751-0101-12 Evofem, 12 applicators $6.054 — Availability likely —
Phexxi 90 mg/5g; 50 mg/5g; 20 mg/5g 69751-0100-03 Evofem, 3 applicators — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
First FDA approval
May 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

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.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 22, 2020 RLD RS ⏳ ~6.4 yr to latest listed protection

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.

Patents & exclusivity — FDA Orange Book
US 11337989 — method of use (U-1)
US 11992472 — method of use (U-1)
US 10568855 — method of use (U-1)
US 11439610 — drug substance
2020 2022 2024 2026 2028 2030 2032
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 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.

Listed patents (4)
PatentTypeUse codeExpires
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
Common questions
Is there a generic version of PHEXX 1.8-1-0.4% VAGINAL GEL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for PHEXX 1.8-1-0.4% VAGINAL GEL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2033 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

🧪 Avoiding an ingredient? See Citric Acid / Lactic Acid / Potassium Bitartrate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerEvofem, Inc.
Application holderEVOFEM INC
FDA applicationNDA208352 (NDA)
Labeler code69751
First marketedAug 2020
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Evofem, Inc. labeler code 69751

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 98 words ▾

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 196 words ▾

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 70 words ▾

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 87 words ▾

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 ~2 min read ▾

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 151 words ▾

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 61 words ▾

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 48 words ▾

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 118 words ▾

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 41 words ▾

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 96 words ▾

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 31 words ▾

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 194 words ▾

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 126 words ▾

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.

🧬 Pharmacokinetics 64 words ▾

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.

🧬 Pharmacodynamics 10 words ▾

12.2Pharmacodynamics Pharmacodynamic studies in humans have not been performed.

🔬 Clinical Studies 203 words ▾

14 CLINICAL STUDIES The efficacy of PHEXX for the prevention of pregnancy was evaluated in a multi-center, open-label, single-arm clinical trial in the United States (AMP002; NCT03243305). The study enrolled females of reproductive potential 18 to 35 years of age with regular menstrual cycles (21 to 35 days). The median age was 27.8 years.

The racial distribution was 70.6% White, 23.7% Black or African American, 2.5% Asian, 0.4% American Indian or Alaska Native, 0.2% Native Hawaiian or Pacific Islander, and 2.7% other. Subjects agreed to engage in at least 3 acts of heterosexual, vaginal intercourse per cycle. Subjects self-administered a 5 gram dose of PHEXX intravaginally up to one hour before each episode of intercourse for up to 7 cycles.

The primary efficacy endpoint was the 7-cycle typical use cumulative pregnancy rate as derived by Kaplan-Meier life-table analysis. A total of 101 on-treatment pregnancies occurred in 1183 subjects contributing 4769 evaluable natural cycles. The 7-cycle cumulative pregnancy rate was 13.7% (95% CI: 10.0%, 17.5%), excluding cycles with back-up contraception, cycles <21 days or >35 days in length and cycles in which no intercourse was reported.

The estimated Pearl Index, calculated based on data from the 7-cycle study, was 27.5 (95% CI: 22.4%, 33.5%).

🧪 Nonclinical Toxicology 46 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies have not been performed with PHEXX. Mutagenesis Mutagenic studies have not been performed with PHEXX. Impairment of Fertility Reproductive studies have not been performed with PHEXX. Upon discontinuation of PHEXX, pregnancy may occur.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 43 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies have not been performed with PHEXX. Mutagenesis Mutagenic studies have not been performed with PHEXX. Impairment of Fertility Reproductive studies have not been performed with PHEXX. Upon discontinuation of PHEXX, pregnancy may occur.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION PHEXX ® (FEX) (lactic acid, citric acid, and potassium bitartrate) vaginal gel For Vaginal Use Only What is PHEXX? PHEXX is a prescription medicine used to prevent pregnancy in females who can become pregnant and choose to use an on-demand method of birth control. PHEXX is not effective at preventing pregnancy when used after vaginal sex.

How well does PHEXX work? Your chance of getting pregnant depends on how well you follow the directions for using PHEXX. The better you follow the directions, the less chance you have of getting pregnant.

It is very important that you follow the directions carefully each time you have vaginal sex. PHEXX does not protect against HIV infection or other sexually transmitted infections (STIs). Before using PHEXX, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or think you are pregnant.

PHEXX is not for use in pregnant women. are breastfeeding or plan to breastfeed. It is not known if PHEXX passes into your breast milk. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use PHEXX?

See the Instructions for Use that come with PHEXX for detailed instructions on the right way to use PHEXX. Use PHEXX exactly as your healthcare provider tells you to use it. PHEXX must be used before vaginal sex.

PHEXX comes as a pre-filled single-dose vaginal applicator. Insert 1 PHEXX pre-filled applicator into your vagina and use PHEXX within 1 hour before each time you have vaginal sex. If you do not have vaginal sex within 1 hour of using PHEXX, you must insert a new PHEXX pre-filled applicator.

If you have vaginal sex more than 1 time within 1 hour, you must use a new PHEXX pre-filled applicator. PHEXX may be used at any time during the menstrual cycle. PHEXX may be used as soon as your healthcare provider tells you it is safe for you to have vaginal sex after childbirth, abortion, or miscarriage.

PHEXX may be used with hormonal contraceptives; and latex, polyurethane, and polyisoprene condoms. PHEXX may be used with a vaginal diaphragm. Avoid using PHEXX with contraceptive vaginal rings.

PHEXX may be used with other medicines used in the vagina to treat infections including miconazole, metronidazole, and tioconazole. What are the possible side effects of PHEXX? PHEXX may cause serious side effects, including: Bladder infection (cystitis) and acute kidney infection (pyelonephritis).

Urinary tract infections are common but can also be serious. You should not use PHEXX if you have a history of urinary tract infections that keep coming back or other problems with your urinary tract. Call your healthcare provider if you have burning with urination or other signs and symptoms of a urinary tract infection such as: burning feeling when passing urine, urine that looks cloudy, pain in the pelvis, or back pain.

Allergic reactions. Avoid using PHEXX if you are a female who can become pregnant and are allergic to lactic acid, citric acid, potassium bitartrate or any of the ingredients in PHEXX; or your sexual partners are allergic to any of the ingredients in PHEXX. Stop using PHEXX if you have a local vulvovaginal reaction.

The most common side effects of PHEXX include: vaginal burning vaginal itching vaginal yeast infection discomfort around the vaginal area bacterial vaginosis vaginal discharge discomfort in the genital area pain while passing urine These are not all the possible side effects of PHEXX. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store PHEXX? Store PHEXX at room temperature between 68°F to 77°F (20°C to 25°C). Store PHEXX in the original foil pouch.

Keep PHEXX and all medicines out of the reach of children. Ge… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE PHEXX ® (FEX) (lactic acid, citric acid, and potassium bitartrate) vaginal gel For Vaginal Use Only These Instructions for Use contain information on how to use PHEXX vaginal gel. Make sure that you read, understand, and follow the Instructions for Use before using PHEXX and each time you get a refill. There may be new information.

Contents: Each box contains 12 foil pouches. Each foil pouch contains a pre-filled applicator and plunger rod (see Figure A ). Each pre-filled applicator contains 1 dose of PHEXX for 1-time use (single use).

Figure A Important Information You Need to Know Before Using PHEXX Use 1 dose of PHEXX within 1 hour before you have vaginal sex. A new PHEXX pre-filled applicator must be used each time you have vaginal sex. If you have vaginal sex more than 1 time within 1 hour, a new PHEXX pre-filled applicator must be used .

Prepare to Use PHEXX Keep the pre-filled applicator and plunger rod in the foil pouch until you are ready to use PHEXX. Step 1: Wash Your Hands Wash your hands with soap and water before opening the foil pouch. Step 2: Remove the Pre-filled Applicator and Plunger Rod from the Foil Pouch Remove the pre-filled applicator and plunger rod from the foil pouch (see Figure B ) .

Figure B Important: Do not remove the pink cap until instructed in Step 4. Insert PHEXX Gel Step 3: Insert the Plunger Rod Gently and slowly insert the plunger rod into the pre-filled applicator. Push until you feel the tip of the plunger rod connect to the inside of the pre-filled applicator (see Figure C ).

Figure C Do not push hard or continue to push after the tip of the plunger rod connects to the inside of the pre-filled applicator. This could cause the gel to go into the pink cap. Use a new pre-filled applicator if the gel goes into the pink cap.

Step 4: Remove the Pink Cap After the plunger rod is connected to the pre-filled applicator, remove the pink cap from the pre-filled applicator (see Figure D ). The extra space between the gel and the end of the pre-filled applicator is normal. The pre-filled applicator is now ready for use.

Figure D Step 5: Insert the PHEXX Pre-filled Applicator into the Vagina Hold the pre-filled applicator at the grooved area closest to the plunger rod (see Figure E ). Figure E Gently insert the pre-filled applicator into the vagina as far as it will comfortably go while you continue to hold it by the grooved area firmly. This can be done sitting with your knees apart, lying on your back with your knees bent (see Figure F ), or while standing with your feet apart or knees bent.

Figure F Step 6: Insert PHEXX Gel While the pre-filled applicator is inserted in your vagina, use your index finger to push the plunger rod down until it stops. This is to make sure you receive the entire dose of PHEXX (see Figure G ). It is normal for a small amount of gel to be left in the applicator.

You will still get the right dose. Figure G Step 7: Remove the Used PHEXX Pre-filled Applicator Gently remove the plunger rod and pre-filled applicator from the vagina (see Figure H ) and throw away (dispose of) the used pre-filled applicator. PHEXX should be used within 1 hour before each time you have vaginal sex .

Use a new pre-filled applicator if you do not have vaginal sex within 1 hour of inserting PHEXX gel and you still plan to have vaginal sex. Figure H Disposing of PHEXX Step 8: Throw Away (Dispose of) the Used PHEXX Pre-filled Applicator Used PHEXX pre-filled applicators and caps should be disposed of in the trash. The cap may be a potential choking hazard.

Storing PHEXX Store PHEXX at room temperature between 68°F to 77°F (20°C to 25°C). Store PHEXX in the original foil pouch. Keep PHEXX and all medicines out of the reach of children.

These Instructions for Use have been approved by the U.S. Food and Drug Administration. For more information, including full prescribing information and information on patient safety, go to www.phexx.com or call 1-833-EVFMBIO.

Manufactured for Evof… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 32 words ▾

PRINCIPAL DISPLAY PANEL - 12 Applicator Box phexx ® (lactic acid, citric acid, and potassium bitartrate) Vaginal Gel 1.8%, 1%, 0.4% NDC 69751-101-12 PN-5065 R01 PRINCIPAL DISPLAY PANEL - 12 Applicator Box

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q4 2025 – Q1 2026 · 2 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.8K
Units reimbursed last 4 qtrs
192.8K
Gross reimbursed last 4 qtrs
$1.19M
Avg / prescription
$420.35
Avg / unit
$6.1941
Latest quarter Q1 2026
2.6KRx
Medicaid pays / g
$6.1941
gross reimbursed
vs
NADAC / g
$6.0541
acquisition cost
=
Spread
+$0.1400
+2% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
76% FFS 24% MCO
Fee-for-service · 2,169 Rx Managed care · 672 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,750 units · 22.4 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 905 units · 15.3 per 100k residents WI Michigan: 1,620 units · 16.1 per 100k residents MI New York: 112,678 units · 576 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 725 units · 17.1 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 2,480 units · 19.8 per 100k residents IL Indiana: 2,045 units · 29.8 per 100k residents IN Ohio: 1,335 units · 11.3 per 100k residents OH Pennsylvania: 780 units · 6.0 per 100k residents PA New Jersey: 3,480 units · 37.5 per 100k residents NJ Massachusetts: 4,770 units · 68.1 per 100k residents MA California: 23,038 units · 59.1 per 100k residents CA Utah: no data reported UT Colorado: 3,215 units · 54.7 per 100k residents CO Nebraska: no data reported NE Missouri: 4,025 units · 65.0 per 100k residents MO Kentucky: 1,745 units · 38.6 per 100k residents KY West Virginia: no data reported WV Virginia: 545 units · 6.3 per 100k residents VA Maryland: 1,470 units · 23.8 per 100k residents MD Connecticut: 2,645 units · 73.1 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 9,445 units · 87.2 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 7,560 units · 165 per 100k residents LA Mississippi: no data reported MS Alabama: 1,200 units · 23.5 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 5,345 units · 23.6 per 100k residents FL
Units reimbursed · per 100k residents
6.0576
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 576 /100k
2 Louisiana 165 /100k
3 North Carolina 87.2 /100k
4 Connecticut 73.1 /100k
5 Massachusetts 68.1 /100k
6 Missouri 65.0 /100k
7 California 59.1 /100k
8 Colorado 54.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Phexx — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Phexx. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$11.9K
Claims incl. refills
30
Beneficiaries
26
Spend / beneficiary
$458.61
Spend / claim
$397.46
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Lactic acid, L-, citric acid monohydrate, and potassium bitartrate — the ingredient across all brands.

Top reported reactions

Pregnancy59
Abortion Spontaneous19
Vulvovaginal Burning Sensation18
Pregnancy On Contraceptive14
Product Administration Error14
Complication Of Device Insertion6
Expired Product Administered6

Reporter sex

175 reports
Male · 2%
Female · 98%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 61 1
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 69751-0100-03 · Evofem, 69751-0400-01 · Evofem →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.