twyneo

Generic: benzoyl peroxide and tretinoin

Labeler: mayne pharma commercial llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name twyneo
Generic Name benzoyl peroxide and tretinoin
Labeler mayne pharma commercial llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

benzoyl peroxide 30 mg/g, tretinoin 1 mg/g

Manufacturer
Mayne Pharma Commercial LLC

Identifiers & Regulatory

Product NDC 51862-771
Product ID 51862-771_8557c350-45c9-48f8-8e1c-cc7569b3e7b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214902
Listing Expiration 2026-12-31
Marketing Start 2025-08-01

Pharmacologic Class

Established (EPC)
retinoid [epc]
Chemical Structure
retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862771
Hyphenated Format 51862-771

Supplemental Identifiers

RxCUI
2565807 2565812
UNII
W9WZN9A0GM 5688UTC01R
NUI
N0000175607 M0018962

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name twyneo (source: ndc)
Generic Name benzoyl peroxide and tretinoin (source: ndc)
Application Number NDA214902 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/g
  • 1 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (51862-771-30) / 30 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

Ingredients (2)

benzoyl peroxide (30 mg/g) tretinoin (1 mg/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "8557c350-45c9-48f8-8e1c-cc7569b3e7b6", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["W9WZN9A0GM", "5688UTC01R"], "rxcui": ["2565807", "2565812"], "spl_set_id": ["654ae869-5bc0-40b3-a423-dcc3270c05d8"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Mayne Pharma Commercial LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (51862-771-30)  / 30 g in 1 BOTTLE, PUMP", "package_ndc": "51862-771-30", "marketing_start_date": "20250801"}], "brand_name": "Twyneo", "product_id": "51862-771_8557c350-45c9-48f8-8e1c-cc7569b3e7b6", "dosage_form": "CREAM", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "51862-771", "generic_name": "Benzoyl Peroxide and Tretinoin", "labeler_name": "Mayne Pharma Commercial LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Twyneo", "active_ingredients": [{"name": "BENZOYL PEROXIDE", "strength": "30 mg/g"}, {"name": "TRETINOIN", "strength": "1 mg/g"}], "application_number": "NDA214902", "marketing_category": "NDA", "marketing_start_date": "20250801", "listing_expiration_date": "20261231"}