Home NDC 0299-5908 EPIDUO
Product NDC 0299-5908
11-digit product format 002995908
Labeler code 0299
Product ID 0299-5908_253bbb0c-966a-0d65-e063-6294a90a5f07
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name adapalene and benzoyl peroxide
Dosage form GEL
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application NDA022320
Marketing category NDA
Marketing start 2008-12-08
Substance ADAPALENE; BENZOYL PEROXIDE
Active strength 1; 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 N022320-001 EPIDUO ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL RLD 2008-12-08
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 N022320-001 8071644 2027-07-18 U-1078 Drug product 2011-12-07 N022320-001 8080537 2027-07-18 U-1078 2011-12-21 N022320-001 8129362 2027-07-18 U-1078 2012-04-04
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 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022320-001 EPIDUO 0.1%;2.5% GEL / TOPICAL AB RLD, RS 2008-12-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 8 · 290 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022320-001 8071644 2027-07-18 U-1078 Drug product 2011-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022320-001 8080537 2027-07-18 U-1078 2011-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022320-001 8129362 2027-07-18 U-1078 2012-04-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022320-001 7820186 2025-11-23 Drug product 2010-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022320-001 8071644 2027-07-18 U-1078 Drug product 2011-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022320-001 8080537 2027-07-18 U-1078 2011-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022320-001 8129362 2027-07-18 U-1078 2012-04-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022320-001 7820186 2025-11-23 Drug product 2010-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022320-001 8071644 2027-07-18 U-1078 Drug product 2011-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022320-001 8080537 2027-07-18 U-1078 2011-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022320-001 8129362 2027-07-18 U-1078 2012-04-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022320-001 7820186 2025-11-23 Drug product 2010-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022320-001 8071644 2027-07-18 U-1078 Drug product 2011-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022320-001 8080537 2027-07-18 U-1078 2011-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022320-001 8129362 2027-07-18 U-1078 2012-04-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022320-001 7820186 2025-11-23 Drug product 2010-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022320-001 8071644 2027-07-18 U-1078 Drug product 2011-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022320-001 8080537 2027-07-18 U-1078 2011-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022320-001 8129362 2027-07-18 U-1078 2012-04-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022320-001 7964202 2024-09-01 U-1078 Drug product 2011-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022320-001 7820186 2025-11-23 Drug product 2010-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022320-001 8071644 2027-07-18 U-1078 Drug product 2011-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022320-001 8080537 2027-07-18 U-1078 2011-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022320-001 8129362 2027-07-18 U-1078 2012-04-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022320-001 7964202 2024-09-01 U-1078 Drug product 2011-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022320-001 7820186 2025-11-23 Drug product 2010-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022320-001 8071644 2027-07-18 U-1078 Drug product 2011-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022320-001 8080537 2027-07-18 U-1078 2011-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022320-001 8129362 2027-07-18 U-1078 2012-04-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022320-001 7964202 2024-09-01 U-1078 Drug product 2011-06-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022320-001 7820186 2025-11-23 Drug product 2010-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022320-001 8071644 2027-07-18 U-1078 Drug product 2011-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022320-001 8080537 2027-07-18 U-1078 2011-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022320-001 8129362 2027-07-18 U-1078 2012-04-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022320-001 7964202 2024-09-01 U-1078 Drug product 2011-06-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022320-001 7820186 2025-11-23 Drug product 2010-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022320-001 8071644 2027-07-18 U-1078 Drug product 2011-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022320-001 8080537 2027-07-18 U-1078 2011-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022320-001 8129362 2027-07-18 U-1078 2012-04-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022320-001 7964202 2024-09-01 U-1078 Drug product 2011-06-23 d06236e962d9…
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 (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 BENZOYL PEROXIDE ACTIVE INGREDIENT W9WZN9A0GM EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 ADAPALENE ACTIVE MOIETY 1L4806J2QF EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 BENZOYL PEROXIDE ACTIVE MOIETY W9WZN9A0GM EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 docusate sodium INACTIVE INGREDIENT F05Q2T2JA0 EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 edetate disodium INACTIVE INGREDIENT 7FLD91C86K EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 glycerin INACTIVE INGREDIENT PDC6A3C0OX EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 Isohexadecane INACTIVE INGREDIENT 918X1OUF1E EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 poloxamer 124 INACTIVE INGREDIENT 1S66E28KXA EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 Sorbitan Monooleate INACTIVE INGREDIENT 06XEA2VD56 EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 Water INACTIVE INGREDIENT 059QF0KO0R EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 9 ADAPALENE ACTIVE INGREDIENT 1L4806J2QF EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 BENZOYL PEROXIDE ACTIVE INGREDIENT W9WZN9A0GM EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 ADAPALENE ACTIVE MOIETY 1L4806J2QF EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 BENZOYL PEROXIDE ACTIVE MOIETY W9WZN9A0GM EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 docusate sodium INACTIVE INGREDIENT F05Q2T2JA0 EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 edetate disodium INACTIVE INGREDIENT 7FLD91C86K EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 Isohexadecane INACTIVE INGREDIENT 918X1OUF1E EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 poloxamer 124 INACTIVE INGREDIENT 1S66E28KXA EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 Sorbitan Monooleate INACTIVE INGREDIENT 06XEA2VD56 EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-5908 EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] 13 Current NDC, Legacy NDC, 7 package rows 20241027_a0610f87-3b39-458a-afa3-66be1fefd1de.zip
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 0299-5908-00 00299590800 1 TUBE in 1 BLISTER PACK (0299-5908-00) / 2 g in 1 TUBE 1 tube 2008-12-08 0000-00-00 Yes No Current 0299-5908-02 00299590802 2 g in 1 TUBE (0299-5908-02) 2 g 2008-12-08 0000-00-00 Yes No Current 0299-5908-25 00299590825 1 BOTTLE, PUMP in 1 CARTON (0299-5908-25) / 45 g in 1 BOTTLE, PUMP 2008-12-08 0000-00-00 No No Current 0299-5908-45 00299590845 1 TUBE in 1 CARTON (0299-5908-45) / 45 g in 1 TUBE 1 tube 2008-12-08 0000-00-00 No No Current