EPSOLAY

Product NDC: 0299-5890
Requested package NDC: 0299-5890-30
11-digit product format: 002995890
Labeler code: 0299
Product ID: 0299-5890_71106ed6-4cab-48f2-a552-f512a9ada02e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzoyl Peroxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Galderma Laboratories, L.P.
Application: NDA214510
Marketing category: NDA
Marketing start: 2022-05-09
Marketing end: 2026-06-30
Substance: BENZOYL PEROXIDE
Active strength: 50 mg/g
NDC exclude flag: No
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0299-5890	0299-5890-30	D	Discontinued by firm		2026-08-03

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	NP	2025-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214510-001	NP	2025-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214510-001	NP	2025-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214510-001	NP	2025-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214510-001	NP	2025-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214510-001	NP	2025-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214510-001	NP	2025-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214510-001	NP	2025-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214510-001	NP	2025-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214510-001	NP	2025-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214510-001	NP	2025-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214510-001	NP	2025-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214510-001	NP	2025-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214510-001	NP	2025-04-22	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214510-001	NP	2025-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214510-001	NP	2025-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214510-001	NP	2025-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214510-001	NP	2025-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214510-001	NP	2025-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214510-001	NP	2025-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214510-001	NP	2025-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214510-001	NP	2025-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214510-001	NP	2025-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214510-001	NP	2025-04-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214510-001	NP	2025-04-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214510-001	NP	2025-04-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214510-001	NP	2025-04-22	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d9d61457-6a5a-41fc-b418-e5479a2904b7	Product name	2	20230303
32012d5c-25ac-49c7-9d4c-1313177fff7c	Product name	1	20230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
3f45980c-c196-47e5-0e5e-48b7c57327c5	Product name	5	20200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0299-5890-00	EPSOLAY	3 g in 1 BOTTLE, PUMP	CREAM	3	5
0299-5890-30	EPSOLAY	30 g in 1 BOTTLE, PUMP	CREAM	30	5
0299-5890-30	EPSOLAY	1 in 1 BOX	CREAM	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0299-5890-00	GM - Gram	0299-5890	fbdf7b9d-338b-49a4-9931-aa2ebbc173b1	1	2022-07-06
0299-5890-30	GM - Gram	0299-5890	eb884b61-e7df-41bb-bd1b-eb75bbddce4d	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0299-5890	EPSOLAY (BENZOYL PEROXIDE) CREAM [GALDERMA LABORATORIES, L.P.]	4	Current NDC, Legacy NDC, 3 package rows	20241114_507e2cd7-6bcf-4606-bc62-694d64537701.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 · 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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W9WZN9A0GM	BENZOYL PEROXIDE	94-36-0	BENZOYL PEROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308693	benzoyl peroxide 5 % Topical Cream	PSN	507e2cd7-6bcf-4606-bc62-694d64537701	5
2600969	EPSOLAY 5 % Topical Cream	PSN	507e2cd7-6bcf-4606-bc62-694d64537701	5
2600969	benzoyl peroxide 50 MG/ML Topical Cream [Epsolay]	SBD	507e2cd7-6bcf-4606-bc62-694d64537701	5
308693	benzoyl peroxide 50 MG/ML Topical Cream	SCD	507e2cd7-6bcf-4606-bc62-694d64537701	5
308693	benzoyl peroxide 5 % Topical Cream	SY	507e2cd7-6bcf-4606-bc62-694d64537701	5
2600969	Epsolay 5 % Topical Cream	SY	507e2cd7-6bcf-4606-bc62-694d64537701	5
2600969	Epsolay 50 MG/ML Topical Cream	SY	507e2cd7-6bcf-4606-bc62-694d64537701	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0299-5890-30	00299589030	1 BOTTLE, PUMP in 1 BOX (0299-5890-30) / 30 g in 1 BOTTLE, PUMP	2022-05-27	2026-06-30	No	No	Current