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ZILXI Minocycline 15 mg/g Aerosol, Foam — NDC 69489-0212-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ZILXI Minocycline 15 mg/g Aerosol, Foam — NDC 69489-212-07 (Billing 69489-0212-07)

by Journey Medical Corporation · 1 CAN in 1 CARTON / 7 g in 1 CAN

This is a package of ZILXI Minocycline 15 mg/g Aerosol, Foam from Journey Medical Corporation, no longer marketed (first marketed Oct 2022), no longer in the FDA NDC Directory.

NDC 69489-0212-07
🏷️ FDA NDC (as labeled) 69489-212-07 billing pads the product segment with a zero
This package
Contains7 g in 1 can Pack sizes3 compare ↓
Product page 69489-0212-03 Also comes in: 30 g 69489-212-30 3 g 69489-212-03
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69489-212-07
Product NDC 69489-212
11-digit billing NDC 69489021207
RxCUI 2375333, 2375338
UNII 0020414E5U
Application # NDA213690
SPL Set ID cbffa96e-2446-43cf-ba5e-38c645302afd
Established class (EPC) Tetracycline-class Drug
Physiologic effect Decreased Prothrombin Activity
Chemical class Tetracyclines
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2022-10-01
Route TOPICAL
Dosage form AEROSOL, FOAM
Substance MINOCYCLINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 2375333
Why two NDCs? The FDA registers this code as 69489-212-07 — 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 → 69489-0212-07. 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 Tetracycline-class Drug class.

Pharmacologic class Tetracycline-class Drug
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Antiinfectives for treatment of acne, Tetracyclines
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

📖 What it is MedlinePlus · NLM

Minocycline topical is used to treat certain types of acne and rosacea. Minocycline is in a class of medications called tetracycline antibiotics. It works to treat acne by killing the bacteria that infects pores and by lowering the amount of oil on your skin that can cause acne.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Capsules, tablets and IV minocycline treat certain bacterial infections. Extended-release tablets and Amzeeq foam treat inflammatory acne. Zilxi foam and...
  • Minocycline capsules and regular tablets can be taken with or without food. Swallow them whole with a full glass of water. Avoid taking them right before lying down, since that is...
  • Nausea, vomiting, diarrhea, headache and dizziness are possible. You may also sunburn more easily, so limit sun and tanning beds. Call your doctor if you have severe diarrhea, visi...
  • These products can reduce how much minocycline your body absorbs. Ask me or your prescriber how to space them out. Also tell us if you take blood thinners, penicillin or isotretino...
📖 Read our full Minocycline guide →
11
Nutrient depletion considerations

Minocycline may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Minocycline nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 g 3 g
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
69489-0212-07 You're viewing this 1 CAN in 1 CARTON / 7 g in 1 CAN 2022-10-01 — Discontinued by firm
69489-0212-30 69489-212-30 1 CAN in 1 CARTON / 30 g in 1 CAN 2023-06-01 — Active
69489-0212-03 69489-212-03 Main listing 1 CAN in 1 CARTON / 3 g in 1 CAN Sample 2023-11-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 can in 1 carton / 7 g in 1 can.
What NDC number is used to bill for this package of ZILXI Minocycline 15 mg/g Aerosol, Foam?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zilxi 15 mg/gthis 69489-0212-07 Journey 1 can — — Discontinued —
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
🛡️
2030
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 Oct 2030. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 28, 2020 RLD RS ⏳ ~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 10213512 — method of use (U-1631)
US 8992896 — method of use (U-1631)
US 9675700 — method of use (U-1631)
US 8865139 — method of use (U-1631)
US 10322186 — method of use (U-1631)
US 10946101 — method of use (U-1631)
US 12138311 — method of use (U-1631)
US 12661407 — method of use (U-1631)
US 10265404 — drug product
US 8945516 — drug product
2020 2022 2024 2026 2028 2030
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 (10)
PatentTypeUse codeExpires
US 10213512 ↗ Method of use U-1631 Oct 1, 2030
US 8992896 ↗ Method of use U-1631 Oct 1, 2030
US 9675700 ↗ Method of use U-1631 Oct 1, 2030
US 8865139 ↗ Method of use U-1631 Oct 1, 2030
US 10322186 ↗ Method of use U-1631 Oct 1, 2030
US 10946101 ↗ Method of use U-1631 Oct 1, 2030
US 12138311 ↗ Method of use U-1631 Oct 1, 2030
US 12661407 ↗ Method of use U-1631 Oct 1, 2030
US 10265404 ↗ Drug product — Oct 1, 2030
US 8945516 ↗ Drug product — Oct 1, 2030
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2030 — 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.

What it looks like

Color Yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerJourney Medical Corporation
Application holderJOURNEY MEDICAL CORP
FDA applicationNDA213690 (NDA)
Labeler code69489
First marketedOct 2022
Product typeHuman Prescription Drug
Portfolio8 products on file
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 ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 136 words ▾

1 INDICATIONS AND USAGE ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults [see Clinical Studies ( 14 )] . Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated [see Warnings and Precautions ( 5.14 )] .

ZILXI is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults. ( 1 ) Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated ( 1 ).

⏱️ Dosage and Administration 128 words ▾

2 DOSAGE AND ADMINISTRATION For topical use only, not for oral, ophthalmic or intravaginal use. After shaking the can well, a small amount of topical foam (e.g. a cherry-sized amount) should be expressed from the can onto the fingertips of the hand and then applied as a thin layer over all areas of the face. Additional ZILXI foam may be used as needed to ensure the entire face is treated.

The topical foam should be applied at approximately the same time each day at least 1 hour before bedtime. The patient should not bathe, shower or swim for at least 1 hour after application of the product. Apply ZILXI over all areas of the face once daily.

ZILXI should be gently rubbed into the skin. ( 2 )

💊 Dosage Forms and Strengths 43 words ▾

3 DOSAGE FORMS AND STRENGTHS Topical foam, 1.5%. Each gram of ZILXI contains 15 mg of minocycline equivalent to 16 mg of minocycline hydrochloride and is supplied as a yellow suspension in a pressurized aluminum aerosol container (can). Foam, 1.5%. ( 3 )

⛔ Contraindications 48 words ▾

4 CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any other ingredients in ZILXI. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the ingredients in ZILXI. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. ( 5.1 ) • The use of tetracycline-class of drugs orally during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth.

( 5.2 , 5.3 , 5.4 , 8.4 ) • If Clostridioides difficile associated diarrhea occurs, discontinue ZILXI. ( 5.5 ) • If liver injury is suspected, discontinue ZILXI. ( 5.6 ) • If renal impairment exists, oral minocycline doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity.

( 5.7 ) • Oral minocycline may cause central nervous system side effects including lightheadedness, dizziness, or vertigo. ( 5.8 ) • Oral minocycline may cause intracranial hypertension in adults and adolescents. Discontinue ZILXI if symptoms occur.

( 5.9 ) • Oral minocycline has been associated with autoimmune syndromes; discontinue ZILXI immediately if symptoms occur. ( 5.10 ) • Photosensitivity can occur with oral tetracycline. Patients should minimize or avoid exposure to natural or artificial sunlight.

( 5.11 ) • Oral minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and DRESS syndrome. Discontinue ZILXI immediately if symptoms occur. ( 5.12 )

5.1Flammability The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).

5.2Teratogenic Effects Minocycline, like other tetracycline-class drugs, may inhibit bone growth when administered orally during pregnancy. Based on animal data, when administered orally, tetracyclines cross the placenta, are found in fetal tissues, and can cause skeletal malformation and retardation of skeletal development on the developing fetus [see Use in Specific Populations ( 8.1 ) and Nonclinical Toxicology ( 13.1 )] .

5.3Tooth Discoloration The use of tetracycline class drugs orally during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term oral use of the tetracycline but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported with oral tetracycline drugs.

Use of tetracycline drugs is not recommended during tooth development.

5.4Inhibition of Bone Growth All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that oral tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated orally early in pregnancy [see Use in Specific Populations ( 8.1 )].

5.5Clostridioides difficile Associated Diarrhea Clostridioides difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including oral minocycline, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most commonly observed adverse reaction (incidence ≥1%) is diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859 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. In three (two Phase 3 and one Phase 2) multicenter, randomized, double-blind, vehicle-controlled trials, adult subjects applied ZILXI or vehicle once daily for 12 weeks. A total of 1,087 subjects were treated with ZILXI and 591 with vehicle.

The majority of subjects were White (97%) and female (70%). Approximately 67% were non-Hispanic/Latino. The mean age was 50.0 years and ages ranged from 18 to 86 years.

The most common adverse reaction reported by ≥1% of subjects treated with ZILXI and more frequently than in subjects treated with vehicle was diarrhea (1% vs. 0%), respectively. During the two Phase 3 trials, local tolerability evaluations were conducted at each study visit by assessment of erythema, telangiectasia, burning/stinging, flushing/blushing, dryness, itching, peeling and hyperpigmentation.

Table 1 presents local tolerance assessments by incidence rate (%) and severity grade. Subjects treated with ZILXI had improved local tolerability signs and symptoms at Week 12 when compared with corresponding baseline values. These occurred at a similar frequency and severity as subjects treated with the vehicle component of ZILXI.

Table 1: Facial Cutaneous Tolerability Assessment *Hyperpigmentation was most frequently assessed as characteristic of inflammatory and post-inflammatory changes associated with inflammatory lesions of rosacea. ** Of 1,008 subjects, 897 had local tolerability assessments at Week 12. ZILXI, (%) (N=1,008**) Symptom/Severity Mild Moderate Severe Erythema 36.2 18.3

0.7Telangiectasia 61.0 18.8 0 Burning/Stinging 13.3 2.8 0 Flushing/Blushing 39.0 9.6

0.9Dryness 23.9 4.0

0.1Itching 20.0 3.3 0 Skin Peeling 16.1 1.9

0.1Hyperpigmentation* 22.5 2.8 0 In a 40-week open-label extension safety study of ZILXI (for a total of up to 52 weeks of treatment) [ NCT03276936 ], frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.

🔄 Drug Interactions 96 words ▾

7 DRUG INTERACTIONS • Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) • Penicillin: avoid coadministration. ( 7.2 )

7.1Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

7.2Penicillin Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

7.3Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Minocycline like other tetracycline-class drugs can cause fetal harm when administered orally to a pregnant woman. ( 5.2 , 5.3 , 5.4 , 8.1 ) • The use of drugs of the tetracycline-class orally during tooth development may cause permanent discoloration of teeth. ( 5.3 , 8.1 , 8.2 , 8.4 ) • Lactation: Breastfeeding not recommended. ( 8.2 )

8.1Pregnancy Risk Summary Available data with ZILXI use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic absorption of ZILXI in humans is low following once daily topical administration of ZILXI under maximal clinical use conditions [see Clinical Pharmacology ( 12.3 )] . Because of low systemic exposure, it is not expected that maternal use of ZILXI will result in significant fetal exposure to the drug.

Tetracycline-class drugs may cause permanent discoloration of teeth and reversible inhibition of bone growth when administered orally during pregnancy [see Warnings and Precautions 5.2 , 5.3 , 5.4 ) . Animal reproduction studies were not conducted with ZILXI. In animal reproduction studies, oral administration of minocycline to pregnant rats and rabbits during organogenesis induced skeletal malformations in fetuses at systemic exposures of 2,000 and 1,300 times, respectively, the maximum recommended human dose (MRHD based on AUC comparison) of ZILXI ( see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data Results of animal studies with oral administration indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development of the developing fetus. Minocycline induced skeletal malformations (bent limb bones) in fetuses when orally administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (2,000 times and 1,300 times, respectively, the systemic exposure at the MRHD based on AUC comparison).

Reduced mean fetal body weight was observed when minocycline was orally administered to pregnant rats during the period of organogenesis at a dose of 10 mg/kg/day (680 times the systemic exposure at the MRHD based on AUC comparison). Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation, at doses of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (1,700 times the systemic exposure at the MRHD based on AUC comparison).

No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).

8.2Lactation Risk Summary Tetracycline-class drugs, including minocycline, are present in breast milk following oral administration. It is not known whether minocycline is present in human milk after topical administration to the nursing mother. There are no data on the effects of minocycline on milk production.

Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with ZILXI [see Warnings and Precaut… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data with ZILXI use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic absorption of ZILXI in humans is low following once daily topical administration of ZILXI under maximal clinical use conditions [see Clinical Pharmacology ( 12.3 )] . Because of low systemic exposure, it is not expected that maternal use of ZILXI will result in significant fetal exposure to the drug.

Tetracycline-class drugs may cause permanent discoloration of teeth and reversible inhibition of bone growth when administered orally during pregnancy [see Warnings and Precautions 5.2 , 5.3 , 5.4 ) . Animal reproduction studies were not conducted with ZILXI. In animal reproduction studies, oral administration of minocycline to pregnant rats and rabbits during organogenesis induced skeletal malformations in fetuses at systemic exposures of 2,000 and 1,300 times, respectively, the maximum recommended human dose (MRHD based on AUC comparison) of ZILXI ( see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data Results of animal studies with oral administration indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development of the developing fetus. Minocycline induced skeletal malformations (bent limb bones) in fetuses when orally administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (2,000 times and 1,300 times, respectively, the systemic exposure at the MRHD based on AUC comparison).

Reduced mean fetal body weight was observed when minocycline was orally administered to pregnant rats during the period of organogenesis at a dose of 10 mg/kg/day (680 times the systemic exposure at the MRHD based on AUC comparison). Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation, at doses of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (1,700 times the systemic exposure at the MRHD based on AUC comparison).

No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).

🧒 Pediatric Use 24 words ▾

8.4Pediatric Use The safety and effectiveness of ZILXI for the treatment of inflammatory lesions of rosacea have not been evaluated in pediatric patients.

🧓 Geriatric Use 64 words ▾

8.5Geriatric Use There were 278 subjects aged 65 or older in the clinical trials of ZILXI (16.6% of 1,678 subjects). No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology 148 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of ZILXI for the treatment of inflammatory lesions of rosacea is unknown.

12.2Pharmacodynamics The pharmacodynamics of ZILXI for the treatment of inflammatory lesions of rosacea are unknown.

12.3Pharmacokinetics In a pharmacokinetic study, male and female subjects 18 years of age or older with inflammatory lesions of rosacea (N=20) applied approximately 2 grams of ZILXI topically to the face once daily for 14 days. The mean ± SD maximum plasma concentration (C max ) and area under the concentration time curve from 0 to 24 hours post dose (AUC 0-24h ) for minocycline on Day 1 were 1.3 ± 0.9 ng/mL and 22.5 ± 16.2 h·ng/mL, respectively. After daily application of ZILXI in subjects with inflammatory lesions of rosacea for 14 days, steady-state was reached by Day 1 and systemic accumulation of minocycline was not evident.

🧬 Mechanism of Action 20 words ▾

12.1Mechanism of Action The mechanism of action of ZILXI for the treatment of inflammatory lesions of rosacea is unknown.

📦 How Supplied / Storage and Handling 148 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZILXI ® (minocycline) topical foam, 1.5% is a yellow suspension supplied in a pressurized aluminum aerosol container (can). Each gram of ZILXI contains 15 mg of minocycline equivalent to 16 mg of minocycline hydrochloride, and is supplied as follows: NDC 69489-212-30 30 g Can Storage ZILXI must be stored at 2 ºC – 8 ºC (36 ºF – 46 ºF) until dispensed to the patient. Once dispensed, the patient is to store ZILXI at room temperature below 25 ºC (77 ºF) for 90 days.

Do not store in the refrigerator. Handling Allow the can to warm to room temperature before first use. Shake can well before use.

WARNING: Flammable. Avoid fire, flame, or smoking during and immediately following application. Contents under pressure.

Do not puncture or incinerate. Do not expose to heat or temperatures above 49 o C (120 o F).

📋 Description 104 words ▾

11 DESCRIPTION Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S‑(4α,4aα,5aα,12aα)]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a‑tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below: C 23 H 27 N 3 O 7 •HClM. W.

493.94 Each gram of ZILXI contains micronized 15 mg minocycline equivalent to 16 mg minocycline hydrochloride in a yellow suspension foam. In addition, the 1.5% ZILXI topical foam contains the following inactive ingredients: soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol. ZILXI topical foam is dispensed from an aluminum container (can) pressurized with propellant (butane + isobutane + propane).

Structural Formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Inform patients using ZILXI (minocycline) topical foam, 1.5% of the following information and instructions: Flammability The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.

Tooth Discoloration Advise caregivers of pediatric patients that ZILXI may cause permanent discoloration of deciduous and permanent teeth during tooth development (generally up to the age of 8 years) based on observations with oral tetracycline. Lactation Advise women that breastfeeding is not recommended during ZILXI therapy. Tissue Hyperpigmentation Inform patients that ZILXI may cause discoloration of skin, scars, teeth or gums based on observations with oral minocycline.

Clostridioides difficile Associated Diarrhea Advise patients that Clostridioides difficile associated diarrhea can occur with oral minocycline therapy. Advise patients to seek medical attention if they develop watery or bloody stools while using ZILXI. Hepatotoxicity Inform patients about the possibility of hepatotoxicity reported with oral minocycline.

Advise patients to seek medical advice if they experience symptoms or signs of hepatotoxicity, including loss of appetite, tiredness, diarrhea, jaundice, increased bleeding tendencies, confusion, and sleepiness. Central Nervous System Effects Inform patients that central nervous system adverse reactions including dizziness or vertigo have been reported with oral minocycline therapy. Caution patients about driving vehicles or using hazardous machinery if they experience such symptoms while on ZILXI.

Intracranial Hypertension Inform patients that intracranial hypertension can occur with minocycline therapy. Advise patients to seek medical attention if they develop unusual headache, visual symptoms, such as blurred vision, diplopia, and vision loss. Photosensitivity Inform patients that photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking oral tetracyclines, including minocycline.

Advise patients to minimize or avoid exposure to natural or artificial UV light (tanning beds or UVA/B treatment) while using ZILXI. Discuss other sun protection measures, if patients need to be outdoors while using ZILXI. Advise patients to discontinue treatment at the first evidence of sunburn.

Autoimmune Syndromes Inform patients that autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with oral tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash and malaise. Advise patients who experience such symptoms to stop the drug immediately and seek medical help.

Other Information ZILXI should be applied exactly as directed. ZILXI may stain fabric. Manufactured by: ASM Aerosol-Service AG, Mohlin, Switzerland Manufactured for: Journey Medical Corporation, Scottsdale, AZ 85258 Product of Portugal or Italy ZIL-P01-R01 ZILXI is a registered trademark of Journey Medical Corporation.

All other trademarks are the properties of their respective owners. Copyright © 2023, Journey Medical Corporation. All rights reserved.

🧬 Pharmacokinetics 109 words ▾

12.3Pharmacokinetics In a pharmacokinetic study, male and female subjects 18 years of age or older with inflammatory lesions of rosacea (N=20) applied approximately 2 grams of ZILXI topically to the face once daily for 14 days. The mean ± SD maximum plasma concentration (C max ) and area under the concentration time curve from 0 to 24 hours post dose (AUC 0-24h ) for minocycline on Day 1 were 1.3 ± 0.9 ng/mL and 22.5 ± 16.2 h·ng/mL, respectively. After daily application of ZILXI in subjects with inflammatory lesions of rosacea for 14 days, steady-state was reached by Day 1 and systemic accumulation of minocycline was not evident.

🧬 Pharmacodynamics 16 words ▾

12.2Pharmacodynamics The pharmacodynamics of ZILXI for the treatment of inflammatory lesions of rosacea are unknown.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The safety and efficacy of once daily use of ZILXI was assessed in two 12-week multicenter, randomized, double-blind, vehicle-controlled trials in subjects with inflammatory lesions of rosacea (Trial 1 [NCT02601963] and Trial 2 [NCT03142451]). Efficacy was assessed in a total of 1,522 subjects 18 years of age and older. ZILXI or its vehicle were applied once daily for 12 weeks; no other topical or systemic medication affecting the course of inflammatory lesions of rosacea was permitted for use during these trials.

Subjects were required to have an inflammatory lesion count in the range 15-75 lesions and an Investigator Global Assessment (IGA) score of 3 (“moderate”) or 4 (“severe”) at baseline. Overall, 96% of subjects were White and 71% were female. Three hundred and eighty-three (25%) subjects were 18 to 40 years of age, 899 (59%) subjects were 41 to 64 years of age, and 240 (16%) subjects were 65 years or older.

At baseline, subjects had a mean inflammatory lesion count of 29.4. Additionally, approximately 87% of subjects had an IGA score of 3 (“moderate”). The co-primary efficacy endpoints were the absolute change from baseline in inflammatory lesion counts at Week 12 and the proportion of subjects with treatment success at Week 12, defined as an IGA score of 0 (“clear”) or 1 (“almost clear”), and at least a two-grade improvement (decrease) from baseline at Week 12.

The efficacy results are presented in Table 2 . Table 2 Efficacy of ZILXI at Week 12 CI: Confidence Interval (1) IGA Success is defined as an IGA score of 0 or 1 and at least a 2-grade improvement from baseline (2) Treatment Difference and 95% CI are based on the CMH test stratified by analysis center (3) Means presented in table are Least Square means (4) Treatment Difference and 95% CI are based on ANCOVA model with treatment and analysis center as factors, and baseline value as covariate Trial 1 Trial 2 ZILXI (N=495) Vehicle (N=256) ZILXI (N=514) Vehicle (N=257) IGA Success (1) 52.1% 43.0% 49.1% 39.0% Treatment Difference (95% CI) (2) 9.0% (1.3%, 16.8%) 10.2% (3.1%, 17.4%) Inflammatory Lesion Count Mean Absolute Change from Baseline (3) -17.6 -15.4 -18.4 -14.5 Treatment Difference (95% CI) (4) -2.2 (-3.7, -0.7) -3.9 (-5.5, -2.2) Mean Percent Change from Baseline (3) -61.3% -54.1% -60.2% -48.9% Treatment Difference (95% CI) (4) -7.3% (-12.5%, -2.1%) -11.3% (-16.7%, -5.9%)

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a carcinogenicity study in which minocycline hydrochloride was orally administered to male and female rats once daily for up to 104 weeks at dosages up to 200 mg/kg/day, minocycline hydrochloride was associated in both sexes with follicular cell tumors of the thyroid gland, including increased incidences of adenomas, carcinomas and the combined incidence of adenomas and carcinomas in males, and adenomas and the combined incidence of adenomas and carcinomas in females.

In a carcinogenicity study in which minocycline hydrochloride was orally administered to male and female mice once daily for up to 104 weeks at dosages up to 150 mg/kg/day, exposure to minocycline hydrochloride did not result in a significantly increased incidence of neoplasms in either males or females. Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test.

Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (27,500 times the systemic exposure at the MRHD based on AUC comparison). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (10,000 or 27,500 times, respectively, the systemic exposure at the MRHD based on AUC comparison), adversely affected spermatogenesis. Effects observed at 300 mg/kg/day of oral minocycline included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells.

Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a carcinogenicity study in which minocycline hydrochloride was orally administered to male and female rats once daily for up to 104 weeks at dosages up to 200 mg/kg/day, minocycline hydrochloride was associated in both sexes with follicular cell tumors of the thyroid gland, including increased incidences of adenomas, carcinomas and the combined incidence of adenomas and carcinomas in males, and adenomas and the combined incidence of adenomas and carcinomas in females.

In a carcinogenicity study in which minocycline hydrochloride was orally administered to male and female mice once daily for up to 104 weeks at dosages up to 150 mg/kg/day, exposure to minocycline hydrochloride did not result in a significantly increased incidence of neoplasms in either males or females. Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test.

Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (27,500 times the systemic exposure at the MRHD based on AUC comparison). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (10,000 or 27,500 times, respectively, the systemic exposure at the MRHD based on AUC comparison), adversely affected spermatogenesis. Effects observed at 300 mg/kg/day of oral minocycline included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells.

Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION ZILXI ® (ZILK-see) (minocycline) topical foam Important Information: ZILXI is for use on the skin only (topical use). ZILXI is not for use in your mouth, eyes, or vagina. What is ZILXI?

ZILXI is a prescription medicine used on the skin (topical) to treat adults with pimples and bumps caused by a condition called rosacea. ZILXI should not be used for the treatment of infections. It is not known if ZILXI is safe and effective in children.

Do not use ZILXI if you are allergic to any tetracycline medicines or to any of the ingredients in ZILXI. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Before using ZILXI, tell your healthcare provider about all of your medical conditions, including if you: have diarrhea or watery stools have liver problems have kidney problems are pregnant or plan to become pregnant.Taking tetracycline medicines by mouth during pregnancy may cause serious side effects on the growth of bone and teeth of your baby.

ZILXI topical foam is used on your skin and it is not known if it will harm your unborn baby. are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with ZILXI. Tell your healthcare provider about all the other medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements, and skin products you use.

Tetracycline medicines taken by mouth may affect the way other medicines work and may increase your chance of developing certain side effects. Especially tell your healthcare provider if you take: a blood thinner medicine a penicillin antibiotic medicine isotretinoin Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take.

Keep a list of them to show your healthcare provider and pharmacist. How should I use ZILXI? See the detailed “ Instructions for Use ” included with this leaflet for directions about how to apply ZILXI the right way.

Use ZILXI exactly as your healthcare provider tells you. Apply ZILXI to your entire face at about the same time each day, at least 1 hour before bedtime. You should apply enough ZILXI to cover the entire face.

Do not bathe, shower, or swim for at least 1 hour after applying ZILXI. Wash your hands after applying ZILXI. What should I avoid while using ZILXI?

ZILXI is flammable. Avoid fire, flames, and smoking when applying and right after you apply ZILXI. Limit your time in sunlight.

Avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use sun protection measures such as sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight. Stop using ZILXI if you get sunburn.

Minocycline taken by mouth may cause feelings of light-headedness, dizziness, or spinning (vertigo). You should not drive or operate dangerous machinery if you have these symptoms during treatment with ZILXI. What are possible side effects of ZILXI?

ZILXI contains minocycline, a tetracycline medicine. Tetracyclines, when taken by mouth, may cause serious side effects, including: Harm to an unborn baby. See “What should I tell my healthcare provider before using ZILXI?” Permanent tooth discoloration.

Tetracycline medicine when taken by mouth may permanently turn a baby or child's teeth yellow-gray-brown during tooth development. You should not use ZILXI during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and from birth up to 8 years of age.

Slow bone growth. Tetracycline medicine taken by mouth may slow bone growth in infants and children. Slow bone growth is reversible after stopping treatment.

Diarrhea. Diarrhea can happen with most antibiotics, including minocycline taken by mouth. This diarrhea may be caused by an infection ( Clostridioides difficile) in your intestines.

Call your healthcare provider right away if you get watery or bloody stools while using ZILXI. Liver problems. Minocycline taken by mouth can… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~1 min read ▾

Container Label (NDC 69489-212-07) - ZILXI 7 gram Physician Sample NDC 69489-212-07 Physician Sample Not for Sale zilxi ® (minocycline) topical foam, 1.5% For topical use only, not for oral, ophthalmic or intravaginal use Rx only 7g Carton (NDC 69489-212-07) - ZILXI 7 gram Physician Sample NDC 69489-212-07 Physician Sample Not for Sale zilxi® (minocycline) topical foam, 1.5% For topical use only, not for oral, ophthalmic or intravaginal use Rx only 7 g JOURNEY Label - Zilxi (7g sample) Carton - Zilxi (7g sample)

Container Label (NDC 69489-212-30) - ZILXI 30 gram Trade Package NDC 69489-212-30 zilxi® (minocycline) topical foam, 1.5% For topical use only, not for oral, ophthalmic or intravaginal use Rx only 30 g Carton (NDC 69489-212-30) - ZILXI 30 gram Trade Package NDC 69489-212-30 zilxi® (minocycline) topical foam, 1.5% For topical use only, not for oral, ophthalmic or intravaginal use Rx only 30g JOURNEY Label - Zilxi (30g) Carton - Zilxi (30g)

Container Label (NDC 69489-212-03) - ZILXI 3 gram Physician Sample NDC 69489-212-03 Physician Sample Not for Sale zilxi® (minocycline) topical foam, 1.5% For topical use only, not for oral, ophthalmic or intravaginal use Rx only 3 g Carton (NDC 69489-212-03) - ZILXI 3 gram Physician Sample NDC 69489-212-03 Physician Sample Not for Sale zilxi® (minocycline) topical foam, 1.5% For topical use only, not for oral, ophthalmic or intravaginal use Rx only 3 g JOURNEY Label - Zilxi (3g sample) Carton - Zilxi (3g sample)

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

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

Medicare Part D (outpatient prescription) spending for Zilxi — 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 Zilxi. 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.
Period
Total Part D spend
$62.8K
Claims incl. refills
121
Beneficiaries
98
Spend / beneficiary
$641.26
Spend / claim
$519.37
Trend by period
💵 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 ZILXI (this brand).

Top reported reactions

Nausea1,057
Pain1,007
Arthralgia986
Fatigue936
Drug Intolerance896
Rash894
Drug Hypersensitivity893

Age at onset

Neonate31
Infant5
Child20
Adolescent140
Adult1,093
Elderly418

Reporter sex

11,474 reports
Male · 35%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization3,725
Life-threatening1,145
Disabling963
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,197 299
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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 can (69489-0212-30), 1 can (69489-0212-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Journey Medical Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 69489-0201-30 · Journey 69489-0311-60 · Journey →
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.