FDA.reportPublic FDA data

fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream [Tri-Luma]

RxCUI
1191264
RxNorm name
fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream [Tri-Luma]
Display name
TRI-LUMA (Topical)
Full name
fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream [Tri-Luma]
Term type
SBD
Status
Active
Strength
0.01-4-0.05%
Dose form
Cream
Route
Topical
Updated
2026-06-17 07:06:25

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112011
Active start
112011
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
tretinoin0.5 MG / 1 MLtretinointretinoin
fluocinolone acetonide0.1 MG / 1 MLfluocinolonefluocinolone acetonide
hydroquinone40 MG / 1 MLhydroquinonehydroquinone

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Cream316982

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
tretinoin10753
fluocinolone25126
hydroquinone5509

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRTri-Luma (fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % ) Topical CreamNAMES
RxNorm Namefluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream [Tri-Luma]NAMES
RxNorm SynonymTri-Luma (fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % ) Topical CreamNAMES
TTYSBDATTRIBUTES
SPL_SET_IDa35fa709-5eb5-4429-b38f-f1e0019bf0eeCODES
RxCUI1191264CODES
MMSL_CODEBD8566CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0299-5950-020299-5950TRI-LUMA fluocinolone acetonide, hydroquinone, and tretinoinGalderma Laboratories, L.P.NDA021112
0299-5950-300299-5950TRI-LUMA fluocinolone acetonide, hydroquinone, and tretinoinGalderma Laboratories, L.P.NDA021112

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0211120299-5950TRI-LUMA fluocinolone acetonide, hydroquinone, and tretinoinNDAGalderma Laboratories, L.P.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00299595002rxnav_ndcsyes
00299595030rxnav_ndcsyes
00299595003rxnav_historical_indirect
00299595005rxnav_historical_indirect
28105030030rxnav_historical_indirect
54868482000rxnav_historical
60433030103rxnav_historical
60433030130rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a35fa709-5eb5-4429-b38f-f1e0019bf0eeTri-Luma 0.01 % / 4 % / 0.05 % Topical CreamPSN18These highlights do not include all the information needed to use TRI-LUMA Cream safely and effectively. See full prescribing information for TRI-LUMA Cream. TRI-LUMA ® (fluocinolone acetonide, hydroquinone, tretinoin) cream, 0.01%/4%/0.05% for topical use Initial U.S. Approval: 200220241024
a35fa709-5eb5-4429-b38f-f1e0019bf0eefluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream [Tri-Luma]SBD18These highlights do not include all the information needed to use TRI-LUMA Cream safely and effectively. See full prescribing information for TRI-LUMA Cream. TRI-LUMA ® (fluocinolone acetonide, hydroquinone, tretinoin) cream, 0.01%/4%/0.05% for topical use Initial U.S. Approval: 200220241024
a35fa709-5eb5-4429-b38f-f1e0019bf0eeTri-Luma (fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % ) Topical CreamSY18These highlights do not include all the information needed to use TRI-LUMA Cream safely and effectively. See full prescribing information for TRI-LUMA Cream. TRI-LUMA ® (fluocinolone acetonide, hydroquinone, tretinoin) cream, 0.01%/4%/0.05% for topical use Initial U.S. Approval: 200220241024

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
a35fa709-5eb5-4429-b38f-f1e0019bf0eeThese highlights do not include all the information needed to use TRI-LUMA Cream safely and effectively. See full prescribing information for TRI-LUMA Cream. TRI-LUMA ® (fluocinolone acetonide, hydroquinone, tretinoin) cream, 0.01%/4%/0.05% for topical use Initial U.S. Approval: 2002Galderma Laboratories, L.P. | Hill Dermaceuticals, Inc. | G Production, Inc.20241024

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC05AACorticosteroidsATC1-4fluocinolone acetonide
ATCS02BACorticosteroidsATC1-4fluocinolone acetonide
ATCS01BACorticosteroids, plainATC1-4fluocinolone acetonide
ATCD07ACCorticosteroids, potent (group III)ATC1-4fluocinolone acetonide
ATCD11AXOther dermatologicalsATC1-4hydroquinone
ATCL01XFRetinoids for cancer treatmentATC1-4tretinoin
ATCD10ADRetinoids for topical use in acneATC1-4tretinoin
FDASPLD012176RetinoidsCHEMhas_chemical_structuretretinoin
FDASPLN0000175576CorticosteroidEPChas_epcfluocinolone acetonide
FDASPLN0000175854Melanin Synthesis InhibitorEPChas_epchydroquinone
FDASPLN0000175607RetinoidEPChas_epctretinoin
FDASPLN0000175450Corticosteroid Hormone Receptor AgonistsMOAhas_moafluocinolone acetonide
FDASPLN0000175850Melanin Synthesis InhibitorsMOAhas_moahydroquinone
FDASPLN0000175851Depigmenting ActivityPEhas_pehydroquinone
MEDRTD005446Fluocinolone AcetonideCHEMhas_ingredientfluocinolone acetonide
MEDRTD005446Fluocinolone AcetonideCHEMhas_ingredientfluocinolone
MEDRTD006873HydroquinonesCHEMhas_ingredienthydroquinone
MEDRTD010226ParabensCHEMci_chemclasstretinoin
MEDRTD014212TretinoinCHEMhas_ingredienttretinoin
MEDRTD000152Acne VulgarisDISEASEmay_treattretinoin
MEDRTD003876Dermatitis, AtopicDISEASEmay_treatfluocinolone acetonide
MEDRTD003876Dermatitis, AtopicDISEASEmay_treatfluocinolone
MEDRTD004342Drug HypersensitivityDISEASEci_withtretinoin
MEDRTD004342Drug HypersensitivityDISEASEci_withhydroquinone
MEDRTD004342Drug HypersensitivityDISEASEci_withfluocinolone acetonide
MEDRTD004342Drug HypersensitivityDISEASEci_withfluocinolone
MEDRTD005148Facial DermatosesDISEASEmay_treattretinoin
MEDRTD005148Facial DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD005148Facial DermatosesDISEASEmay_treatfluocinolone
MEDRTD005533Foot DermatosesDISEASEmay_treatfluocinolone
MEDRTD005533Foot DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD006229Hand DermatosesDISEASEmay_treatfluocinolone
MEDRTD006229Hand DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD017495HyperpigmentationDISEASEmay_treathydroquinone
MEDRTD017495HyperpigmentationDISEASEmay_treattretinoin
MEDRTD006967HypersensitivityDISEASEci_withfluocinolone acetonide
MEDRTD007249InflammationDISEASEmay_treatfluocinolone
MEDRTD007249InflammationDISEASEmay_treatfluocinolone acetonide
MEDRTD007868Leg DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD007868Leg DermatosesDISEASEmay_treatfluocinolone
MEDRTD015473Leukemia, Promyelocytic, AcuteDISEASEmay_treattretinoin
MEDRTD011247PregnancyDISEASEci_withtretinoin
MEDRTD011537PruritusDISEASEmay_treatfluocinolone acetonide
MEDRTD011537PruritusDISEASEmay_treatfluocinolone
MEDRTD011565PsoriasisDISEASEmay_treatfluocinolone acetonide
MEDRTD011565PsoriasisDISEASEmay_treatfluocinolone
MEDRTD012536Scalp DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD013471SunburnDISEASEci_withhydroquinone
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moafluocinolone acetonide
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moafluocinolone
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moafluocinolone acetonide
MEDRTN0000000085Receptor InteractionsMOAhas_moatretinoin
MEDRTN0000020001Tyrosine Kinase InhibitorsMOAhas_moahydroquinone
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moatretinoin
MEDRTN0000008297Antipruritic ActivityPEhas_pefluocinolone acetonide
MEDRTN0000175676Decreased Epithelial ProliferationPEhas_petretinoin
MEDRTN0000008663Decreased Immunologically Active Molecule ActivityPEhas_pefluocinolone acetonide
MEDRTN0000008663Decreased Immunologically Active Molecule ActivityPEhas_pefluocinolone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pefluocinolone acetonide
MEDRTN0000008841Decreased Protein SynthesisPEhas_pefluocinolone
MEDRTN0000009982Decreased Sebaceous Gland ActivityPEhas_petretinoin
MEDRTN0000009979Decreased Sebaceous Gland QuantityPEhas_petretinoin
MEDRTN0000175851Depigmenting ActivityPEhas_pehydroquinone
MEDRTN0000009908VasoconstrictionPEhas_pefluocinolone acetonide
MEDRTN0000009908VasoconstrictionPEhas_pefluocinolone

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.1 MG/ML / 40 MG/ML / 0.5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD8566
CODESNDANDA021112
CODESRxCUI1191264
CODESSPL_SET_IDa35fa709-5eb5-4429-b38f-f1e0019bf0ee
NAMESPrescribable SynonymTri-Luma 0.01 % / 4 % / 0.05 % Topical Cream
NAMESRXNAV_STRTri-Luma (fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % ) Topical Cream
NAMESRxNorm Namefluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream [Tri-Luma]
NAMESRxNorm SynonymTri-Luma (fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % ) Topical Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon