Home NDC 68308-662 adapalene and benzoyl peroxide
Product NDC 68308-662
11-digit product format 683080662
Labeler code 68308
Product ID 68308-662_9d93fe57-cd04-40ff-abe4-a18c27768f9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name adapalene and benzoyl peroxide
Dosage form GEL
Route TOPICAL
Labeler Mayne Pharma Inc.
Application NDA207917
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-02-01
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 adapalene and benzoyl peroxide
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1663745 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68308-662-45 adapalene and benzoyl peroxide 1 in 1 CARTON GEL 1 4 68308-662-45 adapalene and benzoyl peroxide 45 g in 1 BOTTLE, PUMP GEL 45 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68308-662 ADAPALENE AND BENZOYL PEROXIDE GEL [MAYNE PHARMA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20230228_56541736-c70e-4fcd-9614-6cfdc5044136.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 Marketing start Marketing end Sample Exclude flag Status 68308-662-45 68308066245 1 BOTTLE, PUMP in 1 CARTON (68308-662-45) / 45 g in 1 BOTTLE, PUMP 2022-02-01 0000-00-00 No No Current