Home NDC 79167-005 EPSOLAY
Product NDC 79167-005
11-digit product format 791670005
Labeler code 79167
Product ID 79167-005_fc2dcb40-e186-4c62-8d6c-8459df3f9176
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BENZOYL PEROXIDE
Dosage form CREAM
Route TOPICAL
Labeler Sol-Gel Technologies Inc.
Application NDA214510
Marketing category NDA
Marketing start 2022-05-30
Marketing end 0000-00-00
Substance BENZOYL PEROXIDE
Active strength 50 mg/g
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 79167-005-50 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 79167-005-50 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 79167-005-50 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 79167-005-50 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 79167-005-50 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 79167-005-50 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 79167-005-50 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 79167-005-50 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 79167-005-50 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 79167-005-50 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 79167-005-50 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 79167-005-50 557ba5c1ecfa…9c80585c8c6e…
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# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Epsolay BENZOYL PEROXIDE Mayne Pharma Commercial LLC 641981e6-460b-44dd-8146-306c47e5367c 2025-08-11 Warnings, Adverse reactions Exact identifier application applno (NDA): 214510 application number: NDA214510
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 79167-005-50 79167000550 1 CONTAINER in 1 CARTON (79167-005-50) > 50 g in 1 CONTAINER 1 container 2022-05-30 0000-00-00 No No Current