Home NDC 51862-772 Epsolay
Product NDC 51862-772
11-digit product format 518620772
Labeler code 51862
Product ID 51862-772_a27367f0-2505-460d-98a1-20fe24f41657
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzoyl Peroxide
Dosage form CREAM
Route TOPICAL
Labeler Mayne Pharma Commercial LLC
Application NDA214510
Marketing category NDA
Marketing start 2025-08-01
Substance BENZOYL PEROXIDE
Active strength 30 mg/g
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 N214510-001 EPSOLAY BENZOYL PEROXIDE 5% CREAM / TOPICAL RLD, RS 2022-04-22
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214510-001 12156946 2028-02-03 Drug product 2024-12-18 N214510-001 12350382 2028-02-03 Drug product 2025-07-09 N214510-001 9868103 2028-08-08 U-3356 Drug product 2022-04-29 N214510-001 9687465 2032-11-27 U-3356 Drug product 2022-04-29 N214510-001 10933046 2040-02-19 U-3357 Drug product 2022-04-29 N214510-001 10945987 2040-02-19 U-3356 2022-04-29 N214510-001 11541026 2040-02-19 U-3356 2023-02-01 N214510-001 11865100 2040-02-19 U-3357 2024-02-05 N214510-001 11877997 2040-02-19 U-3356 2024-02-16 N214510-001 11986456 2040-02-19 U-3947 2024-06-17 N214510-001 11426378 2040-08-18 U-3356 2022-10-07 N214510-001 11628155 2040-12-27 U-3356 2023-05-17 N214510-001 12295935 2040-12-27 U-3356 2025-05-23 N214510-001 12257348 2041-05-23 U-3947 Drug product 2025-04-10
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.
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 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214510-001 EPSOLAY 5% CREAM / TOPICAL RLD, RS 2022-04-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 252 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 N214510-001 12156946 2028-02-03 Drug product 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 12350382 2028-02-03 Drug product 2025-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 9868103 2028-08-08 U-3356 Drug product 2022-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 9687465 2032-11-27 U-3356 Drug product 2022-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 10933046 2040-02-19 U-3357 Drug product 2022-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 10945987 2040-02-19 U-3356 2022-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 11541026 2040-02-19 U-3356 2023-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 11865100 2040-02-19 U-3357 2024-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 11877997 2040-02-19 U-3356 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 11986456 2040-02-19 U-3947 2024-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 11426378 2040-08-18 U-3356 2022-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 11628155 2040-12-27 U-3356 2023-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 12295935 2040-12-27 U-3356 2025-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214510-001 12257348 2041-05-23 U-3947 Drug product 2025-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 12156946 2028-02-03 Drug product 2024-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 12350382 2028-02-03 Drug product 2025-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 9868103 2028-08-08 U-3356 Drug product 2022-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 9687465 2032-11-27 U-3356 Drug product 2022-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 10933046 2040-02-19 U-3357 Drug product 2022-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 10945987 2040-02-19 U-3356 2022-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 11541026 2040-02-19 U-3356 2023-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 11865100 2040-02-19 U-3357 2024-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 11877997 2040-02-19 U-3356 2024-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 11986456 2040-02-19 U-3947 2024-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 11426378 2040-08-18 U-3356 2022-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 11628155 2040-12-27 U-3356 2023-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 12295935 2040-12-27 U-3356 2025-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214510-001 12257348 2041-05-23 U-3947 Drug product 2025-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214510-001 12156946 2028-02-03 Drug product 2024-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214510-001 12350382 2028-02-03 Drug product 2025-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214510-001 9868103 2028-08-08 U-3356 Drug product 2022-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214510-001 9687465 2032-11-27 U-3356 Drug product 2022-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214510-001 10933046 2040-02-19 U-3357 Drug product 2022-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214510-001 10945987 2040-02-19 U-3356 2022-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214510-001 11541026 2040-02-19 U-3356 2023-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214510-001 11865100 2040-02-19 U-3357 2024-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214510-001 11877997 2040-02-19 U-3356 2024-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214510-001 11986456 2040-02-19 U-3947 2024-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214510-001 11426378 2040-08-18 U-3356 2022-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214510-001 11628155 2040-12-27 U-3356 2023-05-17 6a471c1ec25d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Epsolay
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 30 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W9WZN9A0GM Internal UNII 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 51862-772-30 Epsolay 1 in 1 CARTON CREAM 1 2 51862-772-30 Epsolay 30 g in 1 BOTTLE, PUMP CREAM 30 2
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 51862-772-30 51862077230 1 BOTTLE, PUMP in 1 CARTON (51862-772-30) / 30 g in 1 BOTTLE, PUMP 2025-08-01 No No Current