FDA.reportPublic FDA data

TRI-LUMA

Product NDC
0299-5950
11-digit product format
002995950
Labeler code
0299
Product ID
0299-5950_253d914c-6f0e-c833-e063-6394a90a7ca5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide, hydroquinone, and tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA021112
Marketing category
NDA
Marketing start
2002-01-18
Substance
FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
Active strength
.1; 40; .5 mg/g; mg/g; mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRI-LUMA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.1 mg/g
HYDROQUINONE40 mg/g
TRETINOIN.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M, XV74C1N1AE, 5688UTC01R
Rxcui1191262, 1191264

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-5950-02TRI-LUMA1 in 1 BLISTER PACKCREAM118
0299-5950-02TRI-LUMA3 g in 1 TUBECREAM318
0299-5950-30TRI-LUMA30 g in 1 TUBECREAM3018
0299-5950-30TRI-LUMA1 in 1 CARTONCREAM118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-5950-30GM - Gram0299-59506f9b70a7-c0fa-4d27-bd5b-9a48f9a6170b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOCINOLONE ACETONIDEACTIVE INGREDIENT0CD5FD6S2MTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
HYDROQUINONEACTIVE INGREDIENTXV74C1N1AETRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
TRETINOINACTIVE INGREDIENT5688UTC01RTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
FLUOCINOLONE ACETONIDEACTIVE MOIETY0CD5FD6S2MTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
HYDROQUINONEACTIVE MOIETYXV74C1N1AETRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
TRETINOINACTIVE MOIETY5688UTC01RTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
METHYL GLUCETH-10INACTIVE INGREDIENTN0MWT4C7WHTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11
WATERINACTIVE INGREDIENT059QF0KO0RTRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-5950TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]18Current NDC, Legacy NDC, 4 package rows20241027_a35fa709-5eb5-4429-b38f-f1e0019bf0ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191262fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical CreamPSNa35fa709-5eb5-4429-b38f-f1e0019bf0ee18
1191264Tri-Luma 0.01 % / 4 % / 0.05 % Topical CreamPSNa35fa709-5eb5-4429-b38f-f1e0019bf0ee18
1191264fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream [Tri-Luma]SBDa35fa709-5eb5-4429-b38f-f1e0019bf0ee18
1191262fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical CreamSCDa35fa709-5eb5-4429-b38f-f1e0019bf0ee18
1191262fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical CreamSYa35fa709-5eb5-4429-b38f-f1e0019bf0ee18
1191264Tri-Luma (fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % ) Topical CreamSYa35fa709-5eb5-4429-b38f-f1e0019bf0ee18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-5950-02002995950021 TUBE in 1 BLISTER PACK (0299-5950-02) / 3 g in 1 TUBE1 tube2012-04-010000-00-00YesNoCurrent
0299-5950-30002995950301 TUBE in 1 CARTON (0299-5950-30) / 30 g in 1 TUBE1 tube2007-01-180000-00-00NoNoCurrent