Erythromycin and Benzoyl Peroxide

Product NDC: 68682-900
Requested package NDC: 68682-900-23
11-digit product format: 686820900
Labeler code: 68682
Product ID: 68682-900_eba108cb-67ec-4f94-8fad-0afb3a52899b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erythromycin and Benzoyl Peroxide
Dosage form: KIT
Labeler: Oceanside Pharmaceuticals
Application: NDA050557
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1984-10-26
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 43.

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
N050557-001	BENZAMYCIN	BENZOYL PEROXIDE; ERYTHROMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N050557-001	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 · 43 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
2026-09-14 22:38:34	2026-08	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050557-001	BENZAMYCIN	5%;3%	GEL / TOPICAL	AB	RLD, RS	1984-10-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050557-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050557-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050557-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050557-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050557-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050557-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050557-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050557-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050557-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050557-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050557-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050557-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050557-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050557-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050557-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050557-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050557-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050557-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050557-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050557-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050557-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050557-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050557-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050557-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050557-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050557-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050557-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050557-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050557-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050557-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050557-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050557-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050557-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050557-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050557-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050557-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050557-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050557-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050557-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050557-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Erythromycin and Benzoyl Peroxide
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
244374	Internal RxNorm lookup
308694	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
be5bce27-bbb7-4503-b609-d89a77ee1e05	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
d329c2e1-5ae8-4e64-aea0-77ecea3fa1ab	Product name	3	20250717
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
3b331500-3b74-bd2b-fede-d46839f2f4d5	Product name	6	20240313
fdae2630-eae0-4769-abfd-8f33d5b771b4	Product name	3	20240202
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
8c898317-b543-1e4e-254f-84cec2f3f57e	Product name	2	20191002
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
64ae94c0-3212-d73a-92da-9e6dd85c6ebe	Product name	2	20180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9	Product name	2	20170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810
57850177-5927-151f-e1fa-7e2ca47f81e5	Product name	1	20140508
8ee71591-1d8f-e24e-242b-bfef131e3168	Product name	1	20140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68682-900-23	Erythromycin and Benzoyl Peroxide	1 in 1 CARTON	KIT	1		9
68682-923-23	Erythromycin and Benzoyl Peroxide	20 g in 1 JAR	GEL	20 g	50 mg in 1g	9
68682-924-08	Erythromycin and Benzoyl Peroxide	0.8 g in 1 VIAL, PLASTIC	GEL	0.8 g	30 mg in 1g	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-900-23	GM - Gram	68682-900	3d94ae53-f1f5-45e2-9cb2-02c0f57976eb	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOYL PEROXIDE	ACTIVE INGREDIENT	W9WZN9A0GM	ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]	1
ERYTHROMYCIN	ACTIVE INGREDIENT	63937KV33D	ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]	1
BENZOYL PEROXIDE	ACTIVE MOIETY	W9WZN9A0GM	ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]	1
ERYTHROMYCIN	ACTIVE MOIETY	63937KV33D	ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]	1
LIMONENE, (+)-	INACTIVE INGREDIENT	GFD7C86Q1W	ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-900	ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 3 package rows	20191010_be5bce27-bbb7-4503-b609-d89a77ee1e05.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzamycin	ERYTHROMYCIN AND BENZOYL PEROXIDE	Bausch Health US, LLC	c8c05e98-ec28-4636-8e5c-9a2557483e3c	2020-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050557 application number: NDA050557
Erythromycin and Benzoyl Peroxide	ERYTHROMYCIN AND BENZOYL PEROXIDE	Oceanside Pharmaceuticals	be5bce27-bbb7-4503-b609-d89a77ee1e05	2019-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050557 application number: NDA050557 ndc (package): 68682-900-23 ndc (product): 68682-900 ndc11 (package): 68682090023

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308694	benzoyl peroxide 5 % Topical Gel	PSN	be5bce27-bbb7-4503-b609-d89a77ee1e05	9
244374	erythromycin 3 % / benzoyl peroxide 5 % Topical Gel	PSN	be5bce27-bbb7-4503-b609-d89a77ee1e05	9
244374	benzoyl peroxide 0.05 MG/MG / erythromycin 0.03 MG/MG Topical Gel	SCD	be5bce27-bbb7-4503-b609-d89a77ee1e05	9
308694	benzoyl peroxide 0.05 MG/MG Topical Gel	SCD	be5bce27-bbb7-4503-b609-d89a77ee1e05	9
244374	benzoyl peroxide 5 % / erythromycin 3 % Topical Gel	SY	be5bce27-bbb7-4503-b609-d89a77ee1e05	9
308694	benzoyl peroxide 5 % Topical Gel	SY	be5bce27-bbb7-4503-b609-d89a77ee1e05	9
244374	benzoyl peroxide 50 MG / erythromycin 30 MG per GM Topical Gel	SY	be5bce27-bbb7-4503-b609-d89a77ee1e05	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-900-23	68682090023	1 KIT in 1 CARTON (68682-900-23) * .8 g in 1 VIAL, PLASTIC (68682-924-08) * 20 g in 1 JAR (68682-923-23)	1 kit	1984-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erythromycin-Benzoyl Peroxide Topical Gel	Oceanside Pharmaceuticals \| Bausch Health Companies Inc	2019-06-03	HUMAN PRESCRIPTION DRUG LABEL	9