Prescription medicine

Benzoyl peroxide and tretinoin Brand names: Twyneo

Benzoyl peroxide and tretinoin (Twyneo) is a prescription medicine with an FDA approval on record since 2021. No generic is listed; pharmacies paid $31.66 per gram (Twyneo 0.1%-3% cream pump) in the October 7, 2026 NADAC survey.

No generic listed

Check it at the source: the benzoyl peroxide and tretinoin FDA label on DailyMed (effective August 11, 2025, Mayne Pharma Commercial LLC); the NDA 214902 record on Drugs@FDA; every benzoyl peroxide and tretinoin label on DailyMed.

Highlights of the record

FDA label of August 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
TWYNEO is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.

Forms and strengths

1 mg/g / 30 mg/g
30 mg/g / 1 mg/g

Cream.

On the market

Earliest approval on file: July 26, 2021 Twyneo, Mayne Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Last listed patent: May 23, 2041 Twyneo cream; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $31.66 per gram Twyneo 0.1%-3% cream pump
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 38 through July 30, 2026

What is benzoyl peroxide and tretinoin used for?

From the label: 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.

Conditions named in the indications of benzoyl peroxide and tretinoin's FDA labels, with every medicine labeled for each:

Acne

FDA pharmacologic class: Retinoid.

Source: FDA drug label (Twyneo), Mayne Pharma Commercial LLC, effective August 11, 2025 (SPL set 654ae869-5bc0-40b3-a423-dcc3270c05d8), via openFDA; the full label on DailyMed

What does the patient leaflet for benzoyl peroxide and tretinoin say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while using TWYNEO?
Avoid using TWYNEO on skin areas with cuts, abrasions, eczema, or sunburns. Limit your time in sunlight. You should avoid using sunlamps, tanning beds, and ultraviolet light during treatment with TWYNEO. If you have to be in the sunlight or are sensitive to sunlight, use sunscreen and wear protective clothing or a wide- brimmed hat to cover the treated areas. Avoid getting TWYNEO in your hair or on colored fabric. TWYNEO may bleach hair or colored fabric.

From the patient leaflet: How should I store TWYNEO?
Store TWYNEO at room temperature between 68°F to 77°F (20C° to 25°C). Throw away (discard) TWYNEO 12 weeks after the date you receive it or 60 days after first opening, whichever is sooner. Do not freeze. Keep TWYNEO and all medicines out of reach of children.

Source: FDA drug label (Twyneo), Mayne Pharma Commercial LLC, effective August 11, 2025 (SPL set 654ae869-5bc0-40b3-a423-dcc3270c05d8), via openFDA; the full label on DailyMed

Is there a generic for benzoyl peroxide and tretinoin (Twyneo)?

No generic benzoyl peroxide and tretinoin is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 13 patents for Twyneo cream, the last expiring on May 23, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2021 earliest approval on file
2041 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for benzoyl peroxide and tretinoin (Twyneo)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $31.66 per gram (Twyneo 0.1%-3% cream pump), up 102% from $15.66 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Twyneo 0.1%-3% cream pump (brand)

$31.66

$15.66

July 2025October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Twyneo 0.1%-3% cream pump	Brand	$31.66 per gram	n/a	+102%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What do FAERS reports show for benzoyl peroxide and tretinoin?

The FDA Adverse Event Reporting System holds 38 reports that list benzoyl peroxide and tretinoin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Skin Burning Sensation7
Acne (a use or a product term, not a reaction)6
Erythema (named in the label)6
Dry Skin (named in the label)5
Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)5
Intentional Product Misuse (a use or a product term, not a reaction)4
Pain Of Skin4
Poor Quality Product Administered4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as benzoyl peroxide and tretinoin?

8 other medicines are given the same way (topical) and in the same FDA class as benzoyl peroxide and tretinoin or labeled mainly for the same use (acne), the same class first. Acne lists all 26 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (topical)	Pharmacy cost	Shortage
Adapalene	Acne	34 labelers	$0.504 per gram 0.3% gel	No current entry
Tazarotene	Acne	6 labelers	$6.11 per gram 0.1% gel	No current entry
Trifarotene	Acne	none listed	$16.36 per gram 0.005% cream	No current entry
Salicylic acid	Acne	none listed	$0.102 per patch Callus removers patch	No current entry
Sulfur	Acne	none listed	n/a	No current entry
Dapsone	Acne	16 labelers	$0.664 per gram 5% gel	A presentation being discontinued
Azelaic acid	Acne	5 labelers	$0.441 per gram 15% gel	No current entry
Clascoterone	Acne	none listed	$10.00 per gram 1% cream	No current entry

Every medicine labeled for the same conditions as benzoyl peroxide and tretinoin

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to benzoyl peroxide and tretinoin: 8 medicines for the same use
Other retinoids: the pharmacologic class, with prices and generics
Benzoyl peroxide and tretinoin side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other