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Twyneo tretinoin and benzoyl peroxide 1 mg/g; 30 mg/g Cream, 6 g — NDC 00299-5945-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Twyneo tretinoin and benzoyl peroxide 1 mg/g; 30 mg/g Cream, 6 g — NDC 0299-5945-00 (Billing 00299-5945-00)

by Galderma Laboratories, L.P. · 6 g in 1 TUBE

This is a package of 6 g of Twyneo tretinoin and benzoyl peroxide 1 mg/g; 30 mg/g Cream from Galderma Laboratories, L.P., marketed since Mar 2022 and currently FDA-listed.

NDC 00299-5945-00
🏷️ FDA NDC (as labeled) 0299-5945-00 billing pads the labeler segment with a zero
This package
Contains6 g Pack sizes3 compare ↓
Product page 00299-5945-30 Also comes in: 30 g 0299-5945-30 30 g 0299-5945-05
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0299-5945-00
Product NDC 0299-5945
11-digit billing NDC 00299594500
RxCUI 2565807, 2565812
UNII 5688UTC01R, W9WZN9A0GM
Application # NDA214902
SPL Set ID 27208dff-e376-4c18-b56e-0a260f685a39
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-15
Marketing end 2026-10-31
Route TOPICAL
Dosage form CREAM
Substance TRETINOIN; BENZOYL PEROXIDE

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

GPI-14 90059902853720
GPI class Twyneo
GCN Seq No 082535
GCN 49985
HICL code 047506
Ingredient (HICL) Tretinoin/Benzoyl Peroxide
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5H
Therapeutic class — specific (HIC3) Acne Agents,Topical
AHFS code 84:04.04.00
AHFS class Antibacterials (84:04)
FDB label name TWYNEO 0.1%-3% CREAM PUMP
FDB brand name Twyneo
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 082535
  • GCN: 49985
  • GPI-14 (Medi-Span): 90059902853720
  • HICL (First Databank): 047506
  • AHFS class code: 84:04.04.00
  • RxCUI (RxNorm): 2565807
Why two NDCs? The FDA registers this code as 0299-5945-00 — a 4-4-2 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 labeler segment → 00299-5945-00. 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 Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Retinoids for topical use in acne, Retinoids for cancer treatment
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 TWYNEO 0.1%-3% CREAM PUMP Ingredient Tretinoin/Benzoyl Peroxide
📖 What it is MedlinePlus · NLM

Benzoyl peroxide is used to treat mild to moderate acne.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Twyneo is a cream for acne vulgaris, the common type of acne. It's approved for adults and children 9 and older. It combines tretinoin and benzoyl peroxide, which work in different...
  • Apply a thin layer to the affected areas once a day on clean, dry skin. Keep it away from your eyes, lips, the creases beside your nose, and the inside of your mouth or nose. Wash...
  • Stinging, burning, dryness, peeling, redness and itching where you apply it are the most common. These tend to peak in the first couple of weeks and then ease. If irritation is bot...
  • Stop right away and get medical help if you notice swelling of your face, lips or throat, hives, or trouble breathing. These can be signs of a serious allergic reaction. Also stop...
📖 Read our full Benzoyl Peroxide / Tretinoin 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 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 30 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 Per unit Per pack Marketing startMarketing endStatus
00299-5945-00 You're viewing this 6 g in 1 TUBE — — 2022-03-15 — Active
00299-5945-30 0299-5945-30 Main listing 1 BOTTLE, PUMP in 1 BOX / 30 g in 1 BOTTLE, PUMP $31.66 / g $949.70 2022-03-15 — Active
00299-5945-05 0299-5945-05 30 g in 1 BOTTLE, PUMP — — 2023-07-11 — Active

Pack size FAQ

What quantity is in this package?
This package contains 6 g — 6 g in 1 tube.
How does this package differ from NDC 00299-5945-05?
Both are Twyneo tretinoin and benzoyl peroxide 1 mg/g; 30 mg/g Cream — the drug itself is identical. This page's package is the 6 g one, while NDC 00299-5945-05 is the 30 g package.
What NDC number is used to bill for this package of Twyneo tretinoin and benzoyl peroxide 1 mg/g; 30 mg/g Cream?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Twyneo 30 mg/g; 1 mg/g 51862-0771-30 Mayne 1 bottle $31.657 — Availability likely —
Twyneo 1 mg/g; 30 mg/gthis 00299-5945-00 Galderma 6 g — — 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

🏛️
2021
First FDA approval
Jul 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2041
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 May 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 26, 2021 RLD RS ⏳ ~14.6 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 12295935 — method of use (U-3987)
US 12357602 — method of use (U-3987)
US 12257348 — method of use (U-3987)
US 12491163 — method of use (U-3987)
US 9868103 — method of use (U-3194)
US 10420743 — method of use (U-3194)
US 10653899 — method of use (U-3194)
US 12070629 — method of use (U-3987)
US 12133919 — method of use (U-3987)
US 12053546 — drug product
US 8617580 — drug product
US 11071878 — drug product
US 12156946 — drug product
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041
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 (13)
PatentTypeUse codeExpires
US 12295935 ↗ Method of use U-3987 Dec 27, 2040
US 12357602 ↗ Method of use U-3987 Jul 12, 2038
US 12257348 ↗ Method of use U-3987 May 23, 2041
US 12491163 ↗ Method of use U-3987 May 23, 2041
US 9868103 ↗ Method of use U-3194 Aug 8, 2028
US 10420743 ↗ Method of use U-3194 Jul 12, 2038
US 10653899 ↗ Method of use U-3194 Dec 30, 2030
US 12070629 ↗ Method of use U-3987 Dec 30, 2030
US 12133919 ↗ Method of use U-3987 May 23, 2041
US 12053546 ↗ Drug product — Jun 29, 2032
US 8617580 ↗ Drug product — Feb 3, 2028
US 11071878 ↗ Drug product — Dec 30, 2030
US 12156946 ↗ Drug product — Feb 3, 2028
Common questions
Is there a generic version of TWYNEO 0.1%-3% CREAM PUMP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for TWYNEO 0.1%-3% CREAM PUMP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2041 — 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.

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

LabelerGalderma Laboratories, L.P.
Application holderMAYNE PHARMA LLC
FDA applicationNDA214902 (NDA)
Labeler code00299
First marketedMar 2022
Product typeHuman Prescription Drug
Portfolio50 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. 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 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 57 words ▾

1 INDICATIONS AND USAGE TWYNEO is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is a combination tretinoin, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. ( 1 )

⏱️ Dosage and Administration 96 words ▾

2 DOSAGE AND ADMINISTRATION Apply a thin layer of TWYNEO to the affected areas once daily on clean and dry skin. Avoid contact with the eyes, lips, paranasal creases, and mucous membranes. Wash hands after application.

TWYNEO is for topical use only. TWYNEO is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of TWYNEO to the affected areas once daily.

( 2 ) Avoid contact with eyes, lips, paranasal creases, and mucous membranes. ( 2 ) Wash hand after application. ( 2 ) Not for oral, ophthalmic, or intravaginal use.

( 2 )

💊 Dosage Forms and Strengths 43 words ▾

3 DOSAGE FORMS AND STRENGTHS Cream, 0.1%/3%: Each gram of TWYNEO contains 1mg (0.1%) of tretinoin and 30 mg (3%) of benzoyl peroxide in a yellow cream in a 30-gram bottle with a pump. Cream , 0.1% tretinoin/3% benzoyl peroxide ( 3 )

⛔ Contraindications 44 words ▾

4 CONTRAINDICATIONS TWYNEO is contraindicated in patients with a history of hypersensitivity reaction to benzoyl peroxide or any components of TWYNEO [see Warnings and Precautions (5.1) ] . History of serious hypersensitivity reaction to benzoyl peroxide or any component of TWYNEO. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with use of benzoyl peroxide products. ( 4 , 5.1 ) Skin Irritation: Pain, dryness, exfoliation, erythema, and irritation may occur with use of TWYNEO. Avoid application of TWYNEO to cuts abrasions, eczematous or sunburned skin.

( 5.2 ) Photosensitivity : Minimize unprotected exposure to sunlight and sunlamps. Use sunscreen and protective clothing when sun exposure cannot be avoided. ( 5.3 )

5.1Hypersensitivity Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with the use of benzoyl peroxide products. If a serious hypersensitivity reaction occurs, discontinue TWYNEO immediately and initiate appropriate therapy.

5.2Skin Irritation Patients using TWYNEO may experience application site dryness, pain, exfoliation, erythema, dermatitis, pruritis, and irritation [ see Adverse Reactions (6.1) ]. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of the application of TWYNEO, or discontinue use. Avoid application of TWYNEO to cuts, abrasions, eczematous, or sunburned skin.

5.3Photosensitivity TWYNEO may increase sensitivity to ultraviolet light. Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using TWYNEO. Instruct patients to implement sun protection measures (e.g., sunscreen and loose-fitting clothes) when sun exposure cannot be avoided. Discontinue TWYNEO at the first evidence of sunburn.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥ 1%) are pain, dryness, exfoliation erythema, dermatitis, pruritus and irritation (all at the application site). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical trials experience The following adverse reactions are discussed in greater detail elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1 )] Skin Irritation [see Warnings and Precautions (5.2) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates are 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 two multicenter, randomized, double-blind, vehicle-controlled trials (Trial 1 and 2), 832 subjects 9 years of age and older with facial acne vulgaris applied TWYNEO (N=555) or vehicle (N=277) daily for 12 weeks.

The majority of subjects were White (73%) and female (59%). Approximately 33% were Hispanic/Latino, and 46% were younger than 18 years of age. Adverse reactions reported in ≥ 1.0% of subjects treated with TWYNEO (and for which the rate exceeded the rate for vehicle), as well as the corresponding rates reported in subjects treated with vehicle are presented in Table 1 .

Table 1: Adverse Reactions Reported by ≥ 1% of Subjects with Facial Acne Vulgaris Treated with TWYNEO and More Frequently than Vehicle in Trials 1 and 2 TWYNEO Cream (N = 555) n (%) Vehicle Cream (N = 277) n (%) Application Site Pain* 59 (10.6) 1 (0.4) Application Site Dryness 27 (4.9) 1 (0.4) Application Site Exfoliation 23 (4.1) 0 Application Site Erythema 22 (4.0) 0 Application Site Dermatitis 7 (1.3) 1 (0.4) Application Site Pruritus 7 (1.3) 0 Application Site Irritation 6 (1.1) 1 (0.4) * Application site pain defined as application site stinging, burning or pain.

Local tolerability evaluations were conducted at each study visit in the clinical trial by assessment of erythema, scaling, pigmentation, dryness, itching, burning and stinging. Table 2 presents the active assessment of the signs and symptoms of local facial tolerability at Week 12 in subjects treated with TWYNEO. Table 2.

Facial Cutaneous Tolerability Assessment at Week 12 in Subjects with Acne Vulgaris Treated with TWYNEO TWYNEO (N=494*) (%) Vehicle (N = 264*) (%) Mild Moderate Severe Mild Moderate Severe Erythema 33.0 6.9 0.2 26.9 8.0 0 Pigmentation 27.3 6.3 0.4 26.5 4.5 0 Dryness 22.3 5.3 0.4 16.7 2.3 0 Scaling 16.4 2.6 0 12.9 0.8 0 Burning 5.9 2.2 0 3.4 0.8 0 Itching 11.1 1.8 0 8.7 2.7 0 Stinging 5.3 0.2 0 1.9 1.1 0 * The denominators for calculating the percentages were 494 of 555 subjects treated with TWYNEO and 264 of 277 subjects treated with vehicle in these trials who had cutaneous signs and local tolerability results reported at Week 12.

Local tolerability scores for erythema, scaling, dryness, itching, burning and stinging rose during the first two weeks of treatment and decreased thereafter.

6.2Postmarketing Experience The following adverse reactions have been identified during use of benzoyl peroxide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Anaphylaxis, angioedema and urticaria

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from published observational studies of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Studies conducted with topical benzoyl peroxide have not demonstrated systemic absorption and maternal use is not expected to result in fetal exposure to benzoyl peroxide. There are no data on TWYNEO use in pregnant women.

There are reports of major birth defects reported with maternal use of topical tretinoin similar to those seen in infants exposed to oral retinoids, but these case reports do not establish a pattern or association with tretinoin-related embryopathy ( see Data ). Animal reproductive studies have not been conducted with TWYNEO or benzoyl peroxide. Topical administration of tretinoin to pregnant rats during organogenesis was associated with malformations (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) at doses greater than 1 mg tretinoin/kg/day, approximately 5 times the maximum recommended human dose (MRHD) based on body surface area (BSA) comparison and assuming 100% absorption.

Oral administration of tretinoin to pregnant cynomolgus monkeys during organogenesis was associated with malformations at 10 mg/kg/day (approximately 100 times the MRHD based on BSA comparison and assuming 100% absorption) ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss and other adverse outcomes.

The background risk in the U.S. general population of major birth defects is 2 to 4% of miscarriage is 15 to 20% of clinically recognized pregnancies. Data Human Data While available studies cannot definitively establish the absence of risk, published data from multiple prospective controlled observational studies on the use of topical tretinoin products during pregnancy have not identified an association with topical tretinoin and major birth defects or miscarriage. The available studies have methodologic limitations, including small sample size and in some cases, lack of physical exam by an expert in birth defects.

There are published case reports of infants exposed to topical tretinoin during the first trimester that describe major birth defects similar to those seen in infants exposed to oral retinoids; however, no pattern of malformations has been identified and no causal association has been established in these cases. The significance of these spontaneous reports in terms of risk to the fetus is not known. Animal Data For purposes of comparison of the animal exposure to human exposure, the MRHD is defined as 1.5 g of TWYNEO (containing 0.1% tretinoin) applied daily to a 60-kg person (0.03 mg tretinoin/kg body weight).

Topical tretinoin embryofetal development studies have generated equivocal results. There is evidence for malformations (shortened or kinked tail) after topical tretinoin administration in Wistar rats at doses greater than 1 mg/kg/day (approximately 5 times the MHRD based on BSA comparison and assuming 100% absorption). Anomalies (humerus: short 13%, bent 6%, or parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 50 times the MRHD based on BSA comparison and assuming 100% absorption) was topically applied to pregnant rats during organogenesis.

Increased incidence of domed head and hydrocephaly, typical of retinoid-induced fetal malformations were noted in New Zealand White rabbits administered topical doses greater than 0.2 mg/kg/day (2.2 times the MRHD based on BSA comparison and assuming 100% absorption). Oral tretinoin induced malformations in rats, mice, hamsters, and nonhuman primates when administered during the period of organogenesis. Fetal malformations were observed when tretinoin was orally admin…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available data from published observational studies of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Studies conducted with topical benzoyl peroxide have not demonstrated systemic absorption and maternal use is not expected to result in fetal exposure to benzoyl peroxide. There are no data on TWYNEO use in pregnant women.

There are reports of major birth defects reported with maternal use of topical tretinoin similar to those seen in infants exposed to oral retinoids, but these case reports do not establish a pattern or association with tretinoin-related embryopathy ( see Data ). Animal reproductive studies have not been conducted with TWYNEO or benzoyl peroxide. Topical administration of tretinoin to pregnant rats during organogenesis was associated with malformations (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) at doses greater than 1 mg tretinoin/kg/day, approximately 5 times the maximum recommended human dose (MRHD) based on body surface area (BSA) comparison and assuming 100% absorption.

Oral administration of tretinoin to pregnant cynomolgus monkeys during organogenesis was associated with malformations at 10 mg/kg/day (approximately 100 times the MRHD based on BSA comparison and assuming 100% absorption) ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss and other adverse outcomes.

The background risk in the U.S. general population of major birth defects is 2 to 4% of miscarriage is 15 to 20% of clinically recognized pregnancies. Data Human Data While available studies cannot definitively establish the absence of risk, published data from multiple prospective controlled observational studies on the use of topical tretinoin products during pregnancy have not identified an association with topical tretinoin and major birth defects or miscarriage. The available studies have methodologic limitations, including small sample size and in some cases, lack of physical exam by an expert in birth defects.

There are published case reports of infants exposed to topical tretinoin during the first trimester that describe major birth defects similar to those seen in infants exposed to oral retinoids; however, no pattern of malformations has been identified and no causal association has been established in these cases. The significance of these spontaneous reports in terms of risk to the fetus is not known. Animal Data For purposes of comparison of the animal exposure to human exposure, the MRHD is defined as 1.5 g of TWYNEO (containing 0.1% tretinoin) applied daily to a 60-kg person (0.03 mg tretinoin/kg body weight).

Topical tretinoin embryofetal development studies have generated equivocal results. There is evidence for malformations (shortened or kinked tail) after topical tretinoin administration in Wistar rats at doses greater than 1 mg/kg/day (approximately 5 times the MHRD based on BSA comparison and assuming 100% absorption). Anomalies (humerus: short 13%, bent 6%, or parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 50 times the MRHD based on BSA comparison and assuming 100% absorption) was topically applied to pregnant rats during organogenesis.

Increased incidence of domed head and hydrocephaly, typical of retinoid-induced fetal malformations were noted in New Zealand White rabbits administered topical doses greater than 0.2 mg/kg/day (2.2 times the MRHD based on BSA comparison and assuming 100% absorption). Oral tretinoin induced malformations in rats, mice, hamsters, and nonhuman primates when administered during the period of organogenesis. Fetal malformations were observed when tretinoin was orally administered to pregnant Wistar rat…

🧒 Pediatric Use 92 words ▾

8.4Pediatric Use The safety and effectiveness of TWYNEO for the topical treatment of acne vulgaris have been established in pediatric patients 9 years of age and older based on evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled, 12-week clinical trials and an open-label pharmacokinetic study. A total of 283 pediatric subjects 9 years of age and older received TWYNEO in the clinical studies [ see Clinical Pharmacology (12.3) and Clinical Studies (14) ]. The safety and effectiveness of TWYNEO in pediatric patients below 9 years of age have not been established.

🧓 Geriatric Use 29 words ▾

8.5Geriatric Use Clinical trials of TWYNEO did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently than younger subjects.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects, but the precise mechanism of action is unknown. Tretinoin is a metabolite of vitamin A that binds with high affinity to specific retinoic acid receptors located in both the cytosol and nucleus. Tretinoin activates three members of the retinoic acid (RAR) nuclear receptors (RARα , RARß, RARγ) which act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation.

It has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors, and/or other mechanisms. Although the exact mode of action of tretinoin in acne treatment is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

12.2Pharmacodynamics Pharmacodynamics of TWYNEO in the treatment of acne vulgaris are unknown.

12.3Pharmacokinetics The systemic exposure of benzoyl peroxide was not assessed. Benzoyl peroxide is absorbed by skin where it is converted to benzoic acid and eliminated in the urine. Plasma concentrations of tretinoin and its major metabolites were evaluated in 35 subjects in an open-label, randomized, pharmacokinetic (PK) study.

Subjects 9 years of age and older with acne vulgaris applied a mean dose of 1.9 g TWYNEO to the skin of the face, shoulders, upper back and upper chest once daily for 14 days. Steady-state PK characteristics were determined from samples drawn on Day 14. The mean baseline corrected C max and AUC 0-24 of tretinoin and its metabolites after once daily application of TWYNEO for 14 days are provided in Table 3 .

No detectable levels of the metabolites all-trans 4-keto retinoic acid and 9-cis retinoid acid were found in subjects treated with TWYNEO. Table 3: Pharmacokinetics of Tretinoin and its Major Metabolites When Treated with TWYNEO in Subjects 9 Years of Age and Older With Acne Vulgaris for 14 Days Age Group (years) n Compound Mean(± SD) C max (ng/mL) Mean(± SD) AUC 0-24 (ng-h/mL) ≥ 18 years of age 12 tretinoin 0.15 ± 0.17 0.63 ± 0.95 4-keto 13-cis RA 0.27 ± 0.29 2.88 ± 3.61 13-cis RA 0.21 ± 0.19 1.99 ± 2.90 12 to 17 15 tretinoin 0.19 ± 0.18 1.56 ± 1.97 4-keto 13-cis RA 0.32 ± 0.28 2.39 ± 3.05 13-cis RA 0.28 ± 0.35 1.79 ± 2.79 9 to 11 8 tretinoin 0.18 ± 0.22 2.06 ± 3.96 4-keto 13-cis RA 0.34 ± 0.36 2.89 ± 3.17 13-cis RA 0.13 ± 0.09 0.96 ± 1.36

🧬 Mechanism of Action 145 words ▾

12.1Mechanism of Action Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects, but the precise mechanism of action is unknown. Tretinoin is a metabolite of vitamin A that binds with high affinity to specific retinoic acid receptors located in both the cytosol and nucleus. Tretinoin activates three members of the retinoic acid (RAR) nuclear receptors (RARα , RARß, RARγ) which act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation.

It has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors, and/or other mechanisms. Although the exact mode of action of tretinoin in acne treatment is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

📦 How Supplied / Storage and Handling 82 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied TWYNEO (tretinoin and benzoyl peroxide) cream, 0.1%/3% is a yellow cream and is supplied as: 30-gram bottle with a pump, NDC 0299-5945-30 Storage and Handling Prior to Dispensing: Store TWYNEO between 2ºC to 8ºC (36ºF to 46ºF) until dispensed to the patient. After Dispensing: Store TWYNEO at room temperature between 20ºC to 25ºC (68ºF to 77ºF). Discard 12 weeks after date of dispensing or 60 days after first opening, whichever is sooner.

Do not freeze.

📦 Storage and Handling 60 words ▾

30-gram bottle with a pump, NDC 0299-5945-30 Storage and Handling Prior to Dispensing: Store TWYNEO between 2ºC to 8ºC (36ºF to 46ºF) until dispensed to the patient. After Dispensing: Store TWYNEO at room temperature between 20ºC to 25ºC (68ºF to 77ºF). Discard 12 weeks after date of dispensing or 60 days after first opening, whichever is sooner. Do not freeze.

📋 Description 176 words ▾

11 DESCRIPTION TWYNEO (tretinoin and benzoyl peroxide) cream is a yellow cream for topical use. Each gram of TWYNEO contains 1 mg (0.1%) of tretinoin and 30 mg (3%) of benzoyl peroxide. Tretinoin is a retinoid and benzoyl peroxide is an oxidizing agent.

The chemical name for tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin has the following structural formula: Molecular Formula: C 20 H 28 O 2 Molecular Weight: 300.44 The chemical name for benzoyl peroxide is benzoyl benzenecarboperoxoate. Benzoyl peroxide has the following structural formula: Molecular Formula: C 14 H 10 O 4 Molecular Weight: 242.23 The formulation of TWYNEO uses silica (silicon dioxide) core shell structures to separately micro-encapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the.

TWYNEO contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer type C, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, imidurea, (S)lactic acid, macrogol stearate, mono and di-glycerides, polyquaternium-7, purified water, silicon dioxide, sodium hydroxide, squalane, tetraethyl ortho silicate and white wax.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Hypersensitivity Inform patients that serious hypersensitivity reactions have occurred with the use of benzoyl peroxide products. If a patient experiences a serious hypersensitivity reaction, instruct patient to discontinue TWYNEO immediately and seek medical help [ see Warnings and Precautions ( 5.1 ) ].

Skin Irritation Inform patients that TWYNEO may cause irritation such as erythema, dryness, stinging or burning. Advise the patient to use a moisturizer for irritation. [ see Warnings and Precautions ( 5.2 ) ]. Photosensitivity Advise patients to minimize unprotected exposure to sunlight and sunlamps; recommend the use of sunscreen products and protective apparel (e.g., hat) over treated areas when sun exposure cannot be avoided. [ see Warnings and Precautions ( 5.3 ) ].

Administration Instructions Advise patients to apply TWYNEO exactly as directed in a thin layer, avoiding the eyes, lips, paranasal creases and mucous membranes and to wash hands immediately after application. Inform patients that TWYNEO may bleach hair or colored fabric [ see Dosage and Administration ( 2 ) ]. Discard Instructions Instruct patients to store TWYNEO at room temperature and to discard 12 weeks after date of dispensing or 60 days after first opening, whichever is sooner. [ see How Supplied/Storage and Handling ( 16 ) ].

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle00299-5945-30 66 Rx · $34,051
6 g this page00299-5945-00 No Medicaid data
30 g00299-5945-05 No Medicaid data
Drug total (last 4 qtrs): 66 Rx · 2,070 units · $34,051 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Twyneo — 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 Twyneo. 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
$13.8K
Claims incl. refills
13
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$1,058.57
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 TWYNEO (this brand).

Top reported reactions

Skin Burning Sensation7
Acne6
Erythema6
Dry Skin5
Intentional Product Misuse4
Pain Of Skin4
Poor Quality Product Administered4

Age at onset

Adolescent1
Adult1

Reporter sex

38 reports
Male · 50%
Female · 50%
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 13 0
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
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.
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.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Galderma Laboratories, L.P. has reported a marketing end date of 2026-10-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (00299-5945-30), 30 g (00299-5945-05). 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?
Galderma Laboratories, L.P. 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.
← 00299-5935-02 · Galderma 00299-5950-02 · Galderma →
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.