FDA-filed SPL labeling · retrieved through openFDA

Citric Acid / Lactic Acid / Potassium Bitartrate

Citric acid, lactic acid, and potassium bitartrate is a hormone-free combination gel used as on-demand contraception to prevent pregnancy.

Brand names PhexxiPhexx
Drug classes ⓘ Acidifying Activity
Rx Form 1 Route Vaginal
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 19, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveNov 21, 2023
Clinical labels in scope ⓘ2
AvailabilityRx
Earliest approval/marketing year ⓘ2020
FDA-listed product records ⓘ3
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Oct 1, 2026
⭐ Citric Acid / Lactic Acid / Potassium Bitartrate at a glance The quick version — the full detail is in the Patient Information Guide below.
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HelloPharmacist Editorial Team Bottom Line
Citric acid, lactic acid, and potassium bitartrate — sold as Phexxi and Phexx — is a hormone-free vaginal gel used to prevent pregnancy on demand, applied before each act of vaginal intercourse. It works by keeping vaginal pH acidic enough to reduce sperm movement, but it will not work if used after intercourse. People with a history of recurrent UTIs should avoid it due to a risk of bladder and kidney infections.

📖 Citric Acid / Lactic Acid / Potassium Bitartrate: Patient Information Guide

A plain-language walkthrough of Citric Acid / Lactic Acid / Potassium Bitartrate — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

What Citric Acid / Lactic Acid / Potassium Bitartrate is used for

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This ingredient combination is found in vaginal gels used for hormone-free, on-demand contraception.

  • Phexxi (vaginal gel): FDA-approved to prevent pregnancy in people of reproductive potential, used as needed before vaginal intercourse.
  • Phexx (vaginal gel): FDA-approved to prevent pregnancy in people of reproductive potential, used as needed before vaginal intercourse.
  • Neither Phexxi nor Phexx is effective if applied after intercourse has occurred.
  • These products are not indicated for use before the onset of the first menstrual period.

How Citric Acid / Lactic Acid / Potassium Bitartrate works

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Semen is naturally alkaline, which can raise vaginal pH and make conditions more hospitable for sperm. Lactic acid, citric acid, and potassium bitartrate work together to buffer vaginal pH — keeping it in the normal, slightly acidic range (3.5–4.5) even when semen is present. In clinical studies, this acidic environment significantly reduced sperm motility (movement), making it harder for sperm to reach and fertilize an egg.

How Citric Acid / Lactic Acid / Potassium Bitartrate is taken (dosage)

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Phexxi and Phexx each come as a pre-filled vaginal applicator used right before sex — no daily pill or hormone schedule required. Insert one applicator vaginally up to one hour before each act of vaginal intercourse. If more than one act occurs within that hour, an additional dose is needed for each additional act. Both products can be used at any point in the menstrual cycle.

  • Must be used before intercourse — not after.
  • Can be restarted after childbirth, abortion, or miscarriage when vaginal intercourse is safe to resume.
  • May be combined with condoms, diaphragms, or hormonal contraceptives; do not use with vaginal rings.

Citric Acid / Lactic Acid / Potassium Bitartrate side effects in detail

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Most side effects are local — affecting the vaginal area — and the majority are mild.

  • Vaginal burning sensation (most common)
  • Vaginal itching (pruritus)
  • Vaginal discomfort or pain
  • Vaginal discharge
  • Yeast infection (vulvovaginal mycotic infection)
  • Urinary tract infection (UTI)
  • Bacterial vaginosis
  • Painful urination (dysuria)
  • Genital discomfort reported by some male partners

Serious reactions to watch for: signs of a kidney infection (fever, back or flank pain, nausea) or an allergic reaction. Contact your doctor right away if these occur.

Citric Acid / Lactic Acid / Potassium Bitartrate warnings and precautions

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  • Urinary tract and kidney infections: A small percentage of people in clinical trials developed bladder infections (cystitis) or kidney infections (pyelonephritis) — one case required hospitalization. Anyone with a history of recurrent UTIs or urinary tract abnormalities should not use Phexxi or Phexx.
  • Hypersensitivity (allergic reaction): At least one case of suspected drug hypersensitivity was reported. Avoid use if you have known sensitivity to any ingredient.
  • Not effective after intercourse: Using the gel after sex will not prevent pregnancy.

Citric Acid / Lactic Acid / Potassium Bitartrate interactions: what it interacts with

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Phexxi and Phexx have a few important compatibility considerations with other products used vaginally or for contraception.

  • Vaginal rings: Avoid using Phexxi or Phexx alongside vaginal rings — the combination is not recommended.
  • Condoms and diaphragms: Safe to use together with latex, polyurethane, and polyisoprene condoms, as well as vaginal diaphragms.
  • Hormonal contraceptives: Can be used alongside hormonal birth control methods.
  • Vaginal infection treatments: Miconazole, metronidazole, and tioconazole do not significantly affect how Phexxi or Phexx work — they can be used together safely.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

Before taking Citric Acid / Lactic Acid / Potassium Bitartrate

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  • Recurrent UTIs or urinary tract abnormalities: Do not use Phexxi or Phexx if you have a history of frequent urinary tract infections or structural urinary tract problems.
  • Pregnancy: Discontinue use if you become pregnant — there is no role for this product during pregnancy.
  • Breastfeeding: No data exist on whether the ingredients pass into breast milk; discuss with your healthcare provider.
  • Before first period (pre-menarche): This product is not indicated for use before menarche.
  • Allergies: Do not use if you have had a hypersensitivity reaction to lactic acid, citric acid, or potassium bitartrate.

Pharmacokinetics: how your body processes Citric Acid / Lactic Acid / Potassium Bitartrate

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Formal pharmacokinetic studies in humans have not been performed for Phexxi or Phexx. The amounts of lactic acid, citric acid, and potassium bitartrate absorbed into the bloodstream after vaginal application are not expected to raise any safety concerns. Lab studies showed that commonly used vaginal treatments — including miconazole, metronidazole, and tioconazole — do not meaningfully alter the pH or buffering ability of the gel.

How to store Citric Acid / Lactic Acid / Potassium Bitartrate

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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) .

📄 Written from Citric Acid / Lactic Acid / Potassium Bitartrate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Citric Acid / Lactic Acid / Potassium Bitartrate: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Citric Acid / Lactic Acid / Potassium Bitartrate — the kind of thing our pharmacy team would talk through with you at the counter.

How exactly do I use Phexxi or Phexx — do I take it like a pill?

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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 before sex — up to one hour before is fine, but it has to be before, not after. If you have sex more than once within that hour, you'll need an extra dose each time.

Does it protect against STIs (sexually transmitted infections)?

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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 is a concern, talk to your provider about barrier methods.

Can I use Phexxi or Phexx with my other birth control or vaginal medications?

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Yes, in most cases. Both products can be used alongside hormonal contraceptives, latex or polyurethane condoms, and vaginal diaphragms. They're also safe to combine with common vaginal infection treatments like miconazole or metronidazole. The one thing to avoid is using them at the same time as a vaginal ring — that combination is not recommended.

What side effects should I expect, and when should I call my doctor?

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The most common side effects are local — vaginal burning, itching, or discomfort — and they're usually mild. Some people also experience yeast infections, bacterial vaginosis, or urinary tract infections. You should call your doctor if you develop symptoms of a UTI (burning with urination, frequent urge to go) or, especially, signs of a kidney infection like fever, back pain, or chills — those need prompt attention.

I get UTIs a lot. Is this product safe for me?

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This is actually an important one. If you have a history of recurrent urinary tract infections or any structural abnormalities of your urinary tract, the FDA label specifically says to avoid Phexxi and Phexx. A small number of study participants did develop bladder or kidney infections, including one serious case. Please talk to your doctor about other contraceptive options that might be a better fit for you.

Can I use this while breastfeeding or if I'm pregnant?

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If you become pregnant, you should stop using Phexxi or Phexx — there's no reason to use a contraceptive during pregnancy, and the label advises discontinuing it. If you're breastfeeding, there's currently no data on whether the ingredients pass into breast milk, so check in with your healthcare provider before using it.

Is Citric Acid / Lactic Acid / Potassium Bitartrate available over the counter?

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Citric Acid / Lactic Acid / Potassium Bitartrate is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.

When was Citric Acid / Lactic Acid / Potassium Bitartrate first available?

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Citric Acid / Lactic Acid / Potassium Bitartrate has been available in the United States since at least 2020, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Citric Acid / Lactic Acid / Potassium Bitartrate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 More about Citric Acid / Lactic Acid / Potassium Bitartrate on HelloPharmacist

💊 Citric Acid / Lactic Acid / Potassium Bitartrate forms and strengths (how it comes)

Citric Acid / Lactic Acid / Potassium Bitartrate is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Vaginal cream or gel

Vaginal
Brands Phexx Phexxi
How this form is used
What it may be used for
  • Phexxi is used to prevent pregnancy in people of reproductive potential as an on-demand contraceptive method.
  • Phexx is used to prevent pregnancy in people of reproductive potential as an on-demand contraceptive method.
  • Phexxi and Phexx are not effective when applied after intercourse — they must be used beforehand.
Important instructions
  • Phexxi: Insert one pre-filled applicator vaginally immediately before or up to one hour before each act of vaginal intercourse; use an additional dose if more than one act occurs within that hour.
  • Phexx: Insert one pre-filled applicator vaginally immediately before or up to one hour before each act of vaginal intercourse; use an additional dose if more than one act occurs within that hour.
  • Phexxi and Phexx can be used at any point in the menstrual cycle and can be resumed as soon as it is safe to have vaginal intercourse after childbirth, abortion, or miscarriage.
  • Avoid using Phexxi or Phexx with vaginal rings; both products can be used alongside condoms, diaphragms, and hormonal contraceptives.
Available strengths 2 strengths
3 FDA-listed product records ⓘ

📊 Citric Acid / Lactic Acid / Potassium Bitartrate on the U.S. market: products, makers and brands

How Citric Acid / Lactic Acid / Potassium Bitartrate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
1
Manufacturers
2
Brand names
3
FDA-listed product records ⓘ
2020
First marketed ⓘ

📈 How widely Citric Acid / Lactic Acid / Potassium Bitartrate is used (Medicaid data)

A general measure of how commonly Citric Acid / Lactic Acid / Potassium Bitartrate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Citric Acid / Lactic Acid / Potassium Bitartrate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

17,596
Medicaid prescriptions filled (Q1–Q4 2025)
$7.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Citric Acid / Lactic Acid / Potassium Bitartrate prescribed? Of the 1,599 medications we measure, Citric Acid / Lactic Acid / Potassium Bitartrate ranks #821 by Medicaid prescriptions — more than 49% of them.

Where Citric Acid / Lactic Acid / Potassium Bitartrate ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Citric Acid / Lactic Acid / Potassium Bitartrate product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / potassium bitartrate 0.004 MG/MG Vaginal Gel

17,596 Medicaid prescriptions (Q1–Q4 2025) 100% of Citric Acid / Lactic Acid / Potassium Bitartrate prescriptions shown $7.1M gross reimbursement (before rebates) ≈ $405 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2385348

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Citric Acid / Lactic Acid / Potassium Bitartrate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 5 listed Citric Acid / Lactic Acid / Potassium Bitartrate NDCs with Medicaid activity.

🔍 Compare Citric Acid / Lactic Acid / Potassium Bitartrate products

A representative set of FDA-listed product records for Citric Acid / Lactic Acid / Potassium Bitartrate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Vaginal cream or gel
LACTIC ACID, L- 90 mg/5 g; CITRIC ACID MONOHYDRATE 50 mg/5 g; POTASSIUM BITARTRATE 20 mg/5 g Vaginal Evofem, Inc. × 2 listings NDA View NDC →
50; 90; 20 mg/5 g; mg/5 g; mg/5 g Vaginal Evofem, Inc. NDA View NDC →

Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Citric Acid / Lactic Acid / Potassium Bitartrate NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Citric Acid / Lactic Acid / Potassium Bitartrate RxCUI 2385347 1 dose form · 1 strength

Look up RxCUI 2385347 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Citric Acid / Lactic Acid / Potassium Bitartrate brand names

Phexxi Phexx

🏭 Who makes Citric Acid / Lactic Acid / Potassium Bitartrate: manufacturers and labelers

Evofem, Inc. 3

Citric Acid / Lactic Acid / Potassium Bitartrate drug class (RxNorm)

Citric Acid / Lactic Acid / Potassium Bitartrate belongs to the Organic acids class.

Drug family (ATC) Organic acids
How it works Acidifying Activity

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Sources for this Citric Acid / Lactic Acid / Potassium Bitartrate page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 21, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Citric Acid / Lactic Acid / Potassium Bitartrate.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Citric Acid / Lactic Acid / Potassium Bitartrate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
3
Distinct labelers/manufacturers represented
1
Linked representative label ⓘ
Evofem, Inc.
Linked label effective
Nov 21, 2023
Composite sections available
19
Linked SPL Set ID
173ff411-7227-47b0-94dc-844e1ebaf14e
Linked SPL Document ID
11e3cfeb-3ae2-4e97-88f9-3e4cdf770659
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Evofem, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.