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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct79167-005DDiscontinued by firm2026-08-03
excluded packagepackage79167-00579167-005-50DDiscontinued by firm2026-08-03

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage79167-005-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage79167-005-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage79167-005-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage79167-005-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage79167-005-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage79167-005-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage79167-005-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage79167-005-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage79167-005-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage79167-005-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage79167-005-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage79167-005-50557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214510-001EPSOLAYBENZOYL PEROXIDE5%CREAM / TOPICALRLD, RS2022-04-22

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214510-001121569462028-02-03Drug product2024-12-18
N214510-001123503822028-02-03Drug product2025-07-09
N214510-00198681032028-08-08U-3356Drug product2022-04-29
N214510-00196874652032-11-27U-3356Drug product2022-04-29
N214510-001109330462040-02-19U-3357Drug product2022-04-29
N214510-001109459872040-02-19U-33562022-04-29
N214510-001115410262040-02-19U-33562023-02-01
N214510-001118651002040-02-19U-33572024-02-05
N214510-001118779972040-02-19U-33562024-02-16
N214510-001119864562040-02-19U-39472024-06-17
N214510-001114263782040-08-18U-33562022-10-07
N214510-001116281552040-12-27U-33562023-05-17
N214510-001122959352040-12-27U-33562025-05-23
N214510-001122573482041-05-23U-3947Drug product2025-04-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-225c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214510-001EPSOLAY5%CREAM / TOPICALRLD, RS2022-04-22a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N214510-001121569462028-02-03Drug product2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-001123503822028-02-03Drug product2025-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-00198681032028-08-08U-3356Drug product2022-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-00196874652032-11-27U-3356Drug product2022-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-001109330462040-02-19U-3357Drug product2022-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-001109459872040-02-19U-33562022-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-001115410262040-02-19U-33562023-02-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-001118651002040-02-19U-33572024-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-001118779972040-02-19U-33562024-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-001119864562040-02-19U-39472024-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-001114263782040-08-18U-33562022-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-001116281552040-12-27U-33562023-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-001122959352040-12-27U-33562025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214510-001122573482041-05-23U-3947Drug product2025-04-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001121569462028-02-03Drug product2024-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001123503822028-02-03Drug product2025-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-00198681032028-08-08U-3356Drug product2022-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-00196874652032-11-27U-3356Drug product2022-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001109330462040-02-19U-3357Drug product2022-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001109459872040-02-19U-33562022-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001115410262040-02-19U-33562023-02-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001118651002040-02-19U-33572024-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001118779972040-02-19U-33562024-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001119864562040-02-19U-39472024-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001114263782040-08-18U-33562022-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001116281552040-12-27U-33562023-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001122959352040-12-27U-33562025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001122573482041-05-23U-3947Drug product2025-04-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N214510-001121569462028-02-03Drug product2024-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214510-001123503822028-02-03Drug product2025-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214510-00198681032028-08-08U-3356Drug product2022-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214510-00196874652032-11-27U-3356Drug product2022-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214510-001109330462040-02-19U-3357Drug product2022-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214510-001109459872040-02-19U-33562022-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214510-001115410262040-02-19U-33562023-02-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214510-001118651002040-02-19U-33572024-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214510-001118779972040-02-19U-33562024-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214510-001119864562040-02-19U-39472024-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214510-001114263782040-08-18U-33562022-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214510-001116281552040-12-27U-33562023-05-176a471c1ec25d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214510-001NP2025-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N214510-001NP2025-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214510-001NP2025-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214510-001NP2025-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214510-001NP2025-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214510-001NP2025-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214510-001NP2025-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214510-001NP2025-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214510-001NP2025-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214510-001NP2025-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214510-001NP2025-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214510-001NP2025-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214510-001NP2025-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214510-001NP2025-04-225c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214510-001NP2025-04-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N214510-001NP2025-04-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N214510-001NP2025-04-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214510-001NP2025-04-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N214510-001NP2025-04-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N214510-001NP2025-04-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N214510-001NP2025-04-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N214510-001NP2025-04-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N214510-001NP2025-04-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N214510-001NP2025-04-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N214510-001NP2025-04-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N214510-001NP2025-04-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N214510-001NP2025-04-22cb3db0bc1861…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EpsolayBENZOYL PEROXIDEMayne Pharma Commercial LLC641981e6-460b-44dd-8146-306c47e5367c2025-08-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 214510
application number: NDA214510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79167-005-50791670005501 CONTAINER in 1 CARTON (79167-005-50) > 50 g in 1 CONTAINER1 container2022-05-300000-00-00NoNoCurrent