Home NDC 0299-5906 epiduo forte
Product NDC 0299-5906
11-digit product format 002995906
Labeler code 0299
Product ID 0299-5906_253bb988-14bf-4654-e063-6394a90a0fe0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name adapalene and benzoyl peroxide
Dosage form GEL
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application NDA207917
Marketing category NDA
Marketing start 2015-07-01
Substance ADAPALENE; BENZOYL PEROXIDE
Active strength 3; 25 mg/g; mg/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 1 .
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 N207917-001 EPIDUO FORTE ADAPALENE; BENZOYL PEROXIDE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N207917-001 AB
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 2026-02-19 14:30 UTC 2026-02 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL RLD, RS 2015-07-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207917-001 EPIDUO FORTE 0.3%;2.5% GEL / TOPICAL AB RLD, RS 2015-07-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 5 · 186 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 N207917-001 8445543 2022-12-23 U-1078 2015-07-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207917-001 8785420 2022-12-23 U-1078 2015-07-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207917-001 8809305 2022-12-23 U-1078 2016-01-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207917-001 8936800 2022-12-23 U-1078 Drug product 2015-07-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207917-001 9814690 2022-12-23 U-1078 Drug product 2017-12-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207917-001 8703820 2023-03-12 U-1078 2015-07-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207917-001 8729127 2023-03-12 U-1078 2015-07-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207917-001 9381179 2023-03-12 U-1078 2016-08-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207917-001 9387187 2023-03-12 U-1078 2016-08-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207917-001 8445543 2022-12-23 U-1078 2015-07-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207917-001 8785420 2022-12-23 U-1078 2015-07-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207917-001 8809305 2022-12-23 U-1078 2016-01-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207917-001 8936800 2022-12-23 U-1078 Drug product 2015-07-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207917-001 9814690 2022-12-23 U-1078 Drug product 2017-12-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207917-001 8703820 2023-03-12 U-1078 2015-07-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207917-001 8729127 2023-03-12 U-1078 2015-07-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207917-001 9381179 2023-03-12 U-1078 2016-08-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207917-001 9387187 2023-03-12 U-1078 2016-08-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207917-001 8445543 2022-12-23 U-1078 2015-07-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207917-001 8785420 2022-12-23 U-1078 2015-07-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207917-001 8809305 2022-12-23 U-1078 2016-01-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207917-001 8936800 2022-12-23 U-1078 Drug product 2015-07-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207917-001 9814690 2022-12-23 U-1078 Drug product 2017-12-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207917-001 8703820 2023-03-12 U-1078 2015-07-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207917-001 8729127 2023-03-12 U-1078 2015-07-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207917-001 9381179 2023-03-12 U-1078 2016-08-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207917-001 9387187 2023-03-12 U-1078 2016-08-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207917-001 8445543 2022-12-23 U-1078 2015-07-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207917-001 8785420 2022-12-23 U-1078 2015-07-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207917-001 8809305 2022-12-23 U-1078 2016-01-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207917-001 8936800 2022-12-23 U-1078 Drug product 2015-07-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207917-001 9814690 2022-12-23 U-1078 Drug product 2017-12-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207917-001 8703820 2023-03-12 U-1078 2015-07-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207917-001 8729127 2023-03-12 U-1078 2015-07-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207917-001 9381179 2023-03-12 U-1078 2016-08-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207917-001 9387187 2023-03-12 U-1078 2016-08-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207917-001 8445543 2022-12-23 U-1078 2015-07-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N207917-001 8785420 2022-12-23 U-1078 2015-07-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N207917-001 8809305 2022-12-23 U-1078 2016-01-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N207917-001 8936800 2022-12-23 U-1078 Drug product 2015-07-24 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base epiduo forte
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ADAPALENE 3 mg/g BENZOYL PEROXIDE 25 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1L4806J2QF Internal UNII lookup W9WZN9A0GM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1663745 Internal RxNorm lookup 1663747 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 ADAPALENE ACTIVE INGREDIENT 1L4806J2QF EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 BENZOYL PEROXIDE ACTIVE INGREDIENT W9WZN9A0GM EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 ADAPALENE ACTIVE MOIETY 1L4806J2QF EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 BENZOYL PEROXIDE ACTIVE MOIETY W9WZN9A0GM EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) INACTIVE INGREDIENT M4PPW69Y4H EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 ISOHEXADECANE INACTIVE INGREDIENT 918X1OUF1E EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 POLOXAMER 124 INACTIVE INGREDIENT 1S66E28KXA EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 SORBITAN MONOOLEATE INACTIVE INGREDIENT 06XEA2VD56 EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-5906 EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 8 Current NDC, Legacy NDC, 15 package rows 20241027_f4e5d381-098a-4c93-9ff0-002cae46daac.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 · 2 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 0299-5906-00 00299590600 2 g in 1 TUBE (0299-5906-00) 2 g 2019-11-01 0000-00-00 Yes No Current 0299-5906-02 00299590602 1 TUBE in 1 BLISTER PACK (0299-5906-02) / 2 g in 1 TUBE 1 tube 2015-07-01 0000-00-00 Yes No Current 0299-5906-05 00299590605 1 TUBE in 1 BLISTER PACK (0299-5906-05) / 5 g in 1 TUBE 1 tube 2015-07-01 0000-00-00 Yes No Current 0299-5906-15 00299590615 1 BOTTLE, PUMP in 1 CARTON (0299-5906-15) / 15 g in 1 BOTTLE, PUMP 2015-07-01 0000-00-00 No No Current 0299-5906-30 00299590630 1 BOTTLE, PUMP in 1 CARTON (0299-5906-30) / 30 g in 1 BOTTLE, PUMP 2015-07-01 0000-00-00 No No Current 0299-5906-45 00299590645 1 BOTTLE, PUMP in 1 CARTON (0299-5906-45) / 45 g in 1 BOTTLE, PUMP 2015-07-01 0000-00-00 No No Current 0299-5906-60 00299590660 1 BOTTLE, PUMP in 1 CARTON (0299-5906-60) / 60 g in 1 BOTTLE, PUMP 2015-07-01 0000-00-00 No No Current 0299-5906-70 00299590670 1 BOTTLE, PUMP in 1 CARTON (0299-5906-70) / 70 g in 1 BOTTLE, PUMP 2015-07-01 0000-00-00 No No Current