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
Ingredient	Strength	Base	Basis of strength
tretinoin	0.5 MG / 1 ML	tretinoin	tretinoin
fluocinolone acetonide	0.1 MG / 1 ML	fluocinolone	fluocinolone acetonide
hydroquinone	40 MG / 1 ML	hydroquinone	hydroquinone

Dose Form Concepts#

Dose form, RxCUI table
Dose form	RxCUI
Topical Cream	316982

Derived Ingredient Concepts#

Ingredient, RxCUI table
Ingredient	RxCUI
tretinoin	10753
fluocinolone	25126
hydroquinone	5509

Source Vocabulary Codes#

Code type, Values, Count table
Code type	Values	Count	Category
PRESCRIBABLE	Y	1	ATTRIBUTES
RXNAV_STR	Tri-Luma (fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % ) Topical Cream	1	NAMES
RxNorm Name	fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream [Tri-Luma]	1	NAMES
RxNorm Synonym	Tri-Luma (fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % ) Topical Cream	1	NAMES
TTY	SBD	1	ATTRIBUTES
SPL_SET_ID	a35fa709-5eb5-4429-b38f-f1e0019bf0ee	1	CODES
RxCUI	1191264	1	CODES
MMSL_CODE	BD8566	1	CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDC	Product NDC	Name	Labeler	Application
0299-5950-02	0299-5950	TRI-LUMA fluocinolone acetonide, hydroquinone, and tretinoin	Galderma Laboratories, L.P.	NDA021112
0299-5950-30	0299-5950	TRI-LUMA fluocinolone acetonide, hydroquinone, and tretinoin	Galderma Laboratories, L.P.	NDA021112

Drugs@FDA Applications#

Application, NDC, Name table
Application	NDC	Name	Marketing category	Labeler
NDA021112	0299-5950	TRI-LUMA fluocinolone acetonide, hydroquinone, and tretinoin	NDA	Galderma 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
NDC11	Source	Active
00299595002	rxnav_ndcs	yes
00299595030	rxnav_ndcs	yes
00299595003	rxnav_historical_indirect
00299595005	rxnav_historical_indirect
28105030030	rxnav_historical_indirect
54868482000	rxnav_historical
60433030103	rxnav_historical
60433030130	rxnav_historical

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRI-LUMA	FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN	Galderma Laboratories, L.P.	a35fa709-5eb5-4429-b38f-f1e0019bf0ee	2024-10-24	Warnings, Adverse reactions	Exact identifier ndc (package): 0299-5950-02 ndc (package): 0299-5950-30 ndc (product): 0299-5950 ndc11 (package): 00299595002 ndc11 (package): 00299595030 rxcui: 1191264

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 ID	RxNorm mappings	Terms	SPL version	Label	Effective
a35fa709-5eb5-4429-b38f-f1e0019bf0ee	Tri-Luma 0.01 % / 4 % / 0.05 % Topical Cream [PSN] · fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream [Tri-Luma] [SBD] · Tri-Luma (fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % ) Topical Cream [SY]	3	18	These 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: 2002	20241024

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set ID	Title	Manufacturer	Effective
a35fa709-5eb5-4429-b38f-f1e0019bf0ee	These 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: 2002	Galderma Laboratories, L.P. \| Hill Dermaceuticals, Inc. \| G Production, Inc.	20241024
6f9b70a7-c0fa-4d27-bd5b-9a48f9a6170b		National Council for Prescription Drug Programs	20120724

Drug Classes#

Source, Class ID, Class table
Source	Class ID	Class	Type	Relationship	Drug concept
ATC	C05AA	Corticosteroids	ATC1-4		fluocinolone acetonide
ATC	S02BA	Corticosteroids	ATC1-4		fluocinolone acetonide
ATC	S01BA	Corticosteroids, plain	ATC1-4		fluocinolone acetonide
ATC	D07AC	Corticosteroids, potent (group III)	ATC1-4		fluocinolone acetonide
ATC	D11AX	Other dermatologicals	ATC1-4		hydroquinone
ATC	L01XF	Retinoids for cancer treatment	ATC1-4		tretinoin
ATC	D10AD	Retinoids for topical use in acne	ATC1-4		tretinoin
FDASPL	D012176	Retinoids	CHEM	has_chemical_structure	tretinoin
FDASPL	N0000175576	Corticosteroid	EPC	has_epc	fluocinolone acetonide
FDASPL	N0000175854	Melanin Synthesis Inhibitor	EPC	has_epc	hydroquinone
FDASPL	N0000175607	Retinoid	EPC	has_epc	tretinoin
FDASPL	N0000175450	Corticosteroid Hormone Receptor Agonists	MOA	has_moa	fluocinolone acetonide
FDASPL	N0000175850	Melanin Synthesis Inhibitors	MOA	has_moa	hydroquinone
FDASPL	N0000175851	Depigmenting Activity	PE	has_pe	hydroquinone
MEDRT	D005446	Fluocinolone Acetonide	CHEM	has_ingredient	fluocinolone acetonide
MEDRT	D005446	Fluocinolone Acetonide	CHEM	has_ingredient	fluocinolone
MEDRT	D006873	Hydroquinones	CHEM	has_ingredient	hydroquinone
MEDRT	D010226	Parabens	CHEM	ci_chemclass	tretinoin
MEDRT	D014212	Tretinoin	CHEM	has_ingredient	tretinoin
MEDRT	D000152	Acne Vulgaris	DISEASE	may_treat	tretinoin
MEDRT	D003876	Dermatitis, Atopic	DISEASE	may_treat	fluocinolone acetonide
MEDRT	D003876	Dermatitis, Atopic	DISEASE	may_treat	fluocinolone
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	tretinoin
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	hydroquinone
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	fluocinolone acetonide
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	fluocinolone
MEDRT	D005148	Facial Dermatoses	DISEASE	may_treat	tretinoin
MEDRT	D005148	Facial Dermatoses	DISEASE	may_treat	fluocinolone acetonide
MEDRT	D005148	Facial Dermatoses	DISEASE	may_treat	fluocinolone
MEDRT	D005533	Foot Dermatoses	DISEASE	may_treat	fluocinolone
MEDRT	D005533	Foot Dermatoses	DISEASE	may_treat	fluocinolone acetonide
MEDRT	D006229	Hand Dermatoses	DISEASE	may_treat	fluocinolone
MEDRT	D006229	Hand Dermatoses	DISEASE	may_treat	fluocinolone acetonide
MEDRT	D017495	Hyperpigmentation	DISEASE	may_treat	hydroquinone
MEDRT	D017495	Hyperpigmentation	DISEASE	may_treat	tretinoin
MEDRT	D006967	Hypersensitivity	DISEASE	ci_with	fluocinolone acetonide
MEDRT	D007249	Inflammation	DISEASE	may_treat	fluocinolone
MEDRT	D007249	Inflammation	DISEASE	may_treat	fluocinolone acetonide
MEDRT	D007868	Leg Dermatoses	DISEASE	may_treat	fluocinolone acetonide
MEDRT	D007868	Leg Dermatoses	DISEASE	may_treat	fluocinolone
MEDRT	D015473	Leukemia, Promyelocytic, Acute	DISEASE	may_treat	tretinoin
MEDRT	D011247	Pregnancy	DISEASE	ci_with	tretinoin
MEDRT	D011537	Pruritus	DISEASE	may_treat	fluocinolone acetonide
MEDRT	D011537	Pruritus	DISEASE	may_treat	fluocinolone
MEDRT	D011565	Psoriasis	DISEASE	may_treat	fluocinolone acetonide
MEDRT	D011565	Psoriasis	DISEASE	may_treat	fluocinolone
MEDRT	D012536	Scalp Dermatoses	DISEASE	may_treat	fluocinolone acetonide
MEDRT	D013471	Sunburn	DISEASE	ci_with	hydroquinone
MEDRT	N0000000159	Glucocorticoid Receptor Agonists	MOA	has_moa	fluocinolone acetonide
MEDRT	N0000000134	Lipoxygenase Inhibitors	MOA	has_moa	fluocinolone
MEDRT	N0000000134	Lipoxygenase Inhibitors	MOA	has_moa	fluocinolone acetonide
MEDRT	N0000000085	Receptor Interactions	MOA	has_moa	tretinoin
MEDRT	N0000020001	Tyrosine Kinase Inhibitors	MOA	has_moa	hydroquinone
MEDRT	N0000009915	Unknown Cellular or Molecular Interaction	MOA	has_moa	tretinoin
MEDRT	N0000008297	Antipruritic Activity	PE	has_pe	fluocinolone acetonide
MEDRT	N0000175676	Decreased Epithelial Proliferation	PE	has_pe	tretinoin
MEDRT	N0000008663	Decreased Immunologically Active Molecule Activity	PE	has_pe	fluocinolone acetonide
MEDRT	N0000008663	Decreased Immunologically Active Molecule Activity	PE	has_pe	fluocinolone
MEDRT	N0000008841	Decreased Protein Synthesis	PE	has_pe	fluocinolone acetonide
MEDRT	N0000008841	Decreased Protein Synthesis	PE	has_pe	fluocinolone
MEDRT	N0000009982	Decreased Sebaceous Gland Activity	PE	has_pe	tretinoin
MEDRT	N0000009979	Decreased Sebaceous Gland Quantity	PE	has_pe	tretinoin
MEDRT	N0000175851	Depigmenting Activity	PE	has_pe	hydroquinone
MEDRT	N0000009908	Vasoconstriction	PE	has_pe	fluocinolone acetonide
MEDRT	N0000009908	Vasoconstriction	PE	has_pe	fluocinolone

Group, Type, Concept table
Group	Type	Concept	Source
BN	BN	Tri-Luma	rxnav_allrelated
DF	DF	Topical Cream	rxnav_allrelated
DFG	DFG	Topical Product	rxnav_allrelated
IN	IN	fluocinolone	rxnav_allrelated
IN	IN	hydroquinone	rxnav_allrelated
IN	IN	tretinoin	rxnav_allrelated
MIN	MIN	fluocinolone / hydroquinone / tretinoin	rxnav_allrelated
PIN	PIN	fluocinolone acetonide	rxnav_allrelated
SBD	SBD	fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream [Tri-Luma]	rxnav_allrelated
SBDC	SBDC	fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML [Tri-Luma]	rxnav_allrelated
SBDF	SBDF	fluocinolone / hydroquinone / tretinoin Topical Cream [Tri-Luma]	rxnav_allrelated
SBDFP	SBDFP	fluocinolone acetonide / hydroquinone / tretinoin Topical Cream [Tri-Luma]	rxnav_allrelated
SBDG	SBDG	Tri-Luma Topical Product	rxnav_allrelated
SCD	SCD	fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream	rxnav_allrelated
SCDC	SCDC	fluocinolone acetonide 0.1 MG/ML	rxnav_allrelated
SCDC	SCDC	hydroquinone 40 MG/ML	rxnav_allrelated
SCDC	SCDC	tretinoin 0.5 MG/ML	rxnav_allrelated
SCDF	SCDF	fluocinolone / hydroquinone / tretinoin Topical Cream	rxnav_allrelated
SCDFP	SCDFP	fluocinolone acetonide / hydroquinone / tretinoin Topical Cream	rxnav_allrelated
SCDG	SCDG	fluocinolone / hydroquinone / tretinoin Topical Product	rxnav_allrelated
SCDGP	SCDGP	fluocinolone acetonide / hydroquinone / tretinoin Topical Product	rxnav_allrelated

Properties#

Category, Property, Value table
Category	Property	Value
ATTRIBUTES	AVAILABLE_STRENGTH	0.1 MG/ML / 40 MG/ML / 0.5 MG/ML
ATTRIBUTES	GENERAL_CARDINALITY	MULTI
ATTRIBUTES	HUMAN_DRUG	US
ATTRIBUTES	RXNAV_HUMAN_DRUG	US
ATTRIBUTES	SCHEDULE	0
CODES	NDA	NDA021112
NAMES	Prescribable Synonym	Tri-Luma 0.01 % / 4 % / 0.05 % Topical Cream
SOURCES	Source	Gold Standard Alchemy
SOURCES	Source	Metathesaurus FDA Structured Product Labels
SOURCES	Source	Micromedex RED BOOK
SOURCES	Source	Multum MediSource Lexicon