FDA.reportPublic FDA data

adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [Epiduo]

RxCUI
1663747
RxNorm name
adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [Epiduo]
Display name
EPIDUO (Topical)
Full name
adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [Epiduo]
Term type
SBD
Status
Active
Strength
0.3-2.5%
Dose form
Gel
Route
Topical
Updated
2026-10-20 20:50:21

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092015
Active start
092015
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
benzoyl peroxide0.025 MG / 1 MGbenzoyl peroxidebenzoyl peroxide
adapalene0.003 MG / 1 MGadapaleneadapalene

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Gel346286

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
benzoyl peroxide1418
adapalene60223

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STREpiduo Forte 0.3 % / 2.5 % Topical Gel1NAMES
RxNorm Nameadapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [Epiduo]1NAMES
RxNorm SynonymEpiduo Forte 0.3 % / 2.5 % Topical Gel1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDf4e5d381-098a-4c93-9ff0-002cae46daac1CODES
RxCUI16637471CODES
MMSL_CODEBD303721CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0299-5906-000299-5906epiduo forte adapalene and benzoyl peroxideGalderma Laboratories, L.P.NDA207917
0299-5906-020299-5906epiduo forte adapalene and benzoyl peroxideGalderma Laboratories, L.P.NDA207917
0299-5906-050299-5906epiduo forte adapalene and benzoyl peroxideGalderma Laboratories, L.P.NDA207917
0299-5906-150299-5906epiduo forte adapalene and benzoyl peroxideGalderma Laboratories, L.P.NDA207917
0299-5906-300299-5906epiduo forte adapalene and benzoyl peroxideGalderma Laboratories, L.P.NDA207917
0299-5906-450299-5906epiduo forte adapalene and benzoyl peroxideGalderma Laboratories, L.P.NDA207917
0299-5906-600299-5906epiduo forte adapalene and benzoyl peroxideGalderma Laboratories, L.P.NDA207917
0299-5906-700299-5906epiduo forte adapalene and benzoyl peroxideGalderma Laboratories, L.P.NDA207917

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA2079170299-5906epiduo forte adapalene and benzoyl peroxideNDAGalderma Laboratories, L.P.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 8 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00299590600rxnav_ndcsyes
00299590602rxnav_ndcsyes
00299590605rxnav_ndcsyes
00299590615rxnav_ndcsyes
00299590630rxnav_ndcsyes
00299590645rxnav_ndcsyes
00299590660rxnav_ndcsyes
00299590670rxnav_ndcsyes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
epiduo forteADAPALENE AND BENZOYL PEROXIDEGalderma Laboratories, L.P.f4e5d381-098a-4c93-9ff0-002cae46daac2024-10-24Warnings, Adverse reactionsExact identifier
ndc (package): 0299-5906-05
ndc (package): 0299-5906-70
ndc (package): 0299-5906-45
ndc (package): 0299-5906-60
ndc (package): 0299-5906-30
ndc (package): 0299-5906-15
ndc (package): 0299-5906-02
ndc (package): 0299-5906-00
ndc (product): 0299-5906
ndc11 (package): 00299590615
ndc11 (package): 00299590670
ndc11 (package): 00299590600
ndc11 (package): 00299590660
ndc11 (package): 00299590605
ndc11 (package): 00299590645
ndc11 (package): 00299590630
ndc11 (package): 00299590602
rxcui: 1663747

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f4e5d381-098a-4c93-9ff0-002cae46daacEpiduo Forte 0.3 % / 2.5 % Topical Gel [PSN] · adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [Epiduo] [SBD] · Epiduo Forte 0.3 % / 2.5 % Topical Gel [SY]38These highlights do not include all the information needed to use EPIDUO FORTE safely and effectively. See full prescribing information for EPIDUO FORTE. EPIDUO ® FORTE (adapalene and benzoyl peroxide) topical gel. Initial U.S. Approval: 201520241024

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
f4e5d381-098a-4c93-9ff0-002cae46daacThese highlights do not include all the information needed to use EPIDUO FORTE safely and effectively. See full prescribing information for EPIDUO FORTE. EPIDUO ® FORTE (adapalene and benzoyl peroxide) topical gel. Initial U.S. Approval: 2015Galderma Laboratories, L.P. | G Production Inc.20241024

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD10AEPeroxidesATC1-4benzoyl peroxide
ATCD10ADRetinoids for topical use in acneATC1-4adapalene
FDASPLD012176RetinoidsCHEMhas_chemical_structureadapalene
FDASPLN0000175607RetinoidEPChas_epcadapalene
MEDRTD000068816AdapaleneCHEMhas_ingredientadapalene
MEDRTD001585Benzoyl PeroxideCHEMhas_ingredientbenzoyl peroxide
MEDRTD000152Acne VulgarisDISEASEmay_treatadapalene
MEDRTD000152Acne VulgarisDISEASEmay_treatbenzoyl peroxide
MEDRTD004342Drug HypersensitivityDISEASEci_withadapalene
MEDRTD004342Drug HypersensitivityDISEASEci_withbenzoyl peroxide
MEDRTD012393RosaceaDISEASEmay_treatbenzoyl peroxide
MEDRTN0000000170Free Radical Scavenging ActivityMOAhas_moabenzoyl peroxide
MEDRTN0000000242Transcription Factor ActivityMOAhas_moaadapalene
MEDRTN0000008342Cellular Division Phase AlterationPEhas_peadapalene
MEDRTN0000008344Cellular Growth Phase ArrestPEhas_peadapalene
MEDRTN0000175676Decreased Epithelial ProliferationPEhas_peadapalene
MEDRTN0000008663Decreased Immunologically Active Molecule ActivityPEhas_peadapalene
MEDRTN0000009982Decreased Sebaceous Gland ActivityPEhas_pebenzoyl peroxide
MEDRTN0000009982Decreased Sebaceous Gland ActivityPEhas_peadapalene
MEDRTN0000009973Keratin AlterationPEhas_peadapalene

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.003 MG/MG / 0.025 MG/MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA207917
NAMESPrescribable SynonymEpiduo Forte 0.3 % / 2.5 % Topical Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon