Home NDC 0299-5950 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021112-001 TRI-LUMA FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021112-001 TRI-LUMA 0.01%;4%;0.05% CREAM / TOPICAL RLD, RS 2002-01-18 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021112-001 8247395 2022-10-25 Drug product 2012-10-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021112-001 8653053 2022-10-25 Drug product 2014-03-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021112-001 7915243 2023-09-08 Drug product 2011-03-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021112-001 7939516 2023-09-08 Drug product 2011-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021112-001 8247395 2022-10-25 Drug product 2012-10-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021112-001 8653053 2022-10-25 Drug product 2014-03-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021112-001 7915243 2023-09-08 Drug product 2011-03-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021112-001 7939516 2023-09-08 Drug product 2011-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021112-001 8247395 2022-10-25 Drug product 2012-10-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021112-001 8653053 2022-10-25 Drug product 2014-03-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021112-001 7915243 2023-09-08 Drug product 2011-03-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021112-001 7939516 2023-09-08 Drug product 2011-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021112-001 8247395 2022-10-25 Drug product 2012-10-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021112-001 8653053 2022-10-25 Drug product 2014-03-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021112-001 7915243 2023-09-08 Drug product 2011-03-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021112-001 7939516 2023-09-08 Drug product 2011-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021112-001 8247395 2022-10-25 Drug product 2012-10-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021112-001 8653053 2022-10-25 Drug product 2014-03-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021112-001 7915243 2023-09-08 Drug product 2011-03-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021112-001 7939516 2023-09-08 Drug product 2011-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021112-001 8247395 2022-10-25 Drug product 2012-10-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021112-001 8653053 2022-10-25 Drug product 2014-03-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021112-001 7915243 2023-09-08 Drug product 2011-03-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021112-001 7939516 2023-09-08 Drug product 2011-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021112-001 8247395 2022-10-25 Drug product 2012-10-05 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021112-001 8653053 2022-10-25 Drug product 2014-03-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021112-001 7915243 2023-09-08 Drug product 2011-03-31 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021112-001 7939516 2023-09-08 Drug product 2011-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021112-001 8247395 2022-10-25 Drug product 2012-10-05 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021112-001 8653053 2022-10-25 Drug product 2014-03-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021112-001 7915243 2023-09-08 Drug product 2011-03-31 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021112-001 7939516 2023-09-08 Drug product 2011-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021112-001 8247395 2022-10-25 Drug product 2012-10-05 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021112-001 8653053 2022-10-25 Drug product 2014-03-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021112-001 7915243 2023-09-08 Drug product 2011-03-31 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021112-001 7939516 2023-09-08 Drug product 2011-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021112-001 8247395 2022-10-25 Drug product 2012-10-05 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021112-001 8653053 2022-10-25 Drug product 2014-03-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021112-001 7915243 2023-09-08 Drug product 2011-03-31 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021112-001 7939516 2023-09-08 Drug product 2011-05-17 c0c555d07b60…
Additional Listing Data#
Finished product Yes
Brand name base TRI-LUMA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOCINOLONE ACETONIDE .1 mg/g HYDROQUINONE 40 mg/g TRETINOIN .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0CD5FD6S2M Internal UNII lookup XV74C1N1AE Internal UNII lookup 5688UTC01R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191262 Internal RxNorm lookup 1191264 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUOCINOLONE ACETONIDE ACTIVE INGREDIENT 0CD5FD6S2M TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 HYDROQUINONE ACTIVE INGREDIENT XV74C1N1AE TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 TRETINOIN ACTIVE INGREDIENT 5688UTC01R TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 FLUOCINOLONE ACETONIDE ACTIVE MOIETY 0CD5FD6S2M TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 HYDROQUINONE ACTIVE MOIETY XV74C1N1AE TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 TRETINOIN ACTIVE MOIETY 5688UTC01R TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 METHYL GLUCETH-10 INACTIVE INGREDIENT N0MWT4C7WH TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 SODIUM METABISULFITE INACTIVE INGREDIENT 4VON5FNS3C TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11 WATER INACTIVE INGREDIENT 059QF0KO0R TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-5950 TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.] 18 Current NDC, Legacy NDC, 4 package rows 20241027_a35fa709-5eb5-4429-b38f-f1e0019bf0ee.zip
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 application applno (NDA): 021112 application number: NDA021112 ndc (product): 0299-5950
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0299-5950-02 00299595002 1 TUBE in 1 BLISTER PACK (0299-5950-02) / 3 g in 1 TUBE 1 tube 2012-04-01 0000-00-00 Yes No Current 0299-5950-30 00299595030 1 TUBE in 1 CARTON (0299-5950-30) / 30 g in 1 TUBE 1 tube 2007-01-18 0000-00-00 No No Current