Home NDC 0299-5935-02 AKLIEF
Product NDC 0299-5935
Requested package NDC 0299-5935-02
11-digit product format 002995935
Labeler code 0299
Product ID 0299-5935_21db90dd-c7e5-79d1-e063-6294a90ab57e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name trifarotene
Dosage form CREAM
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application NDA211527
Marketing category NDA
Marketing start 2019-10-04
Substance TRIFAROTENE
Active strength 50 ug/g
Pharmacologic classes 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 43 .
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 N211527-001 AKLIEF TRIFAROTENE 0.005% CREAM / TOPICAL RLD, RS 2019-10-04
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211527-001 7807708 2031-07-19 Drug substance, Drug product 2019-10-31 N211527-001 9084778 2033-05-30 U-134 Drug product 2019-10-31 N211527-001 9498465 2033-05-30 U-1033 Drug product 2021-06-17
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 · 41 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 2026-09-14 22:38:34 2026-08 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211527-001 AKLIEF 0.005% CREAM / TOPICAL RLD, RS 2019-10-04 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 191 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N211527-001 7807708 2031-07-19 Drug substance, Drug product 2019-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211527-001 9084778 2033-05-30 U-134 Drug product 2019-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211527-001 9498465 2033-05-30 U-1033 Drug product 2021-06-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211527-001 7807708 2031-07-19 Drug substance, Drug product 2019-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211527-001 9084778 2033-05-30 U-134 Drug product 2019-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211527-001 9498465 2033-05-30 U-1033 Drug product 2021-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211527-001 7807708 2031-07-19 Drug substance, Drug product 2019-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211527-001 9084778 2033-05-30 U-134 Drug product 2019-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211527-001 9498465 2033-05-30 U-1033 Drug product 2021-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211527-001 8227507 2025-12-21 U-818 2019-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211527-001 8470871 2025-12-21 U-2639 2019-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211527-001 7807708 2031-07-19 Drug substance, Drug product 2019-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211527-001 9084778 2033-05-30 U-134 Drug product 2019-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211527-001 9498465 2033-05-30 U-1033 Drug product 2021-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211527-001 8227507 2025-12-21 U-818 2019-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211527-001 8470871 2025-12-21 U-2639 2019-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211527-001 7807708 2031-07-19 Drug substance, Drug product 2019-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211527-001 9084778 2033-05-30 U-134 Drug product 2019-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211527-001 9498465 2033-05-30 U-1033 Drug product 2021-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211527-001 8227507 2025-12-21 U-818 2019-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211527-001 8470871 2025-12-21 U-2639 2019-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211527-001 7807708 2031-07-19 Drug substance, Drug product 2019-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211527-001 9084778 2033-05-30 U-134 Drug product 2019-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211527-001 9498465 2033-05-30 U-1033 Drug product 2021-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211527-001 8227507 2025-12-21 U-818 2019-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211527-001 8470871 2025-12-21 U-2639 2019-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211527-001 7807708 2031-07-19 Drug substance, Drug product 2019-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211527-001 9084778 2033-05-30 U-134 Drug product 2019-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211527-001 9498465 2033-05-30 U-1033 Drug product 2021-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211527-001 8227507 2025-12-21 U-818 2019-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211527-001 8470871 2025-12-21 U-2639 2019-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211527-001 7807708 2031-07-19 Drug substance, Drug product 2019-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211527-001 9084778 2033-05-30 U-134 Drug product 2019-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211527-001 9498465 2033-05-30 U-1033 Drug product 2021-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211527-001 8227507 2025-12-21 U-818 2019-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211527-001 8470871 2025-12-21 U-2639 2019-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211527-001 7807708 2031-07-19 Drug substance, Drug product 2019-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211527-001 9084778 2033-05-30 U-134 Drug product 2019-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211527-001 9498465 2033-05-30 U-1033 Drug product 2021-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211527-001 8227507 2025-12-21 U-818 2019-10-31 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base AKLIEF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIFAROTENE 50 ug/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J8RN2W0HK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2205642 Internal RxNorm lookup 2205647 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-5935 AKLIEF (TRIFAROTENE) CREAM [GALDERMA LABORATORIES, L.P.] 7 Current NDC, Legacy NDC, 8 package rows 20240918_62d910db-85a6-4696-b69b-4bd2f3080cfc.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.
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 0299-5935-02 00299593502 1 TUBE in 1 BLISTER PACK (0299-5935-02) / 2 g in 1 TUBE 1 tube 2019-10-04 0000-00-00 Yes No Current