Home NDC 64980-328 Erythromycin and Benzoyl Peroxide
Product NDC 64980-328
11-digit product format 649800328
Labeler code 64980
Product ID 64980-328_8547932c-ed72-4e13-b8fe-2b78919399d5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Erythromycin and Benzoyl Peroxide
Dosage form GEL
Route TOPICAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA065385
Marketing category ANDA
Marketing start 2016-10-18
Substance BENZOYL PEROXIDE; ERYTHROMYCIN
Active strength 50; 30 mg/g; mg/g
Pharmacologic classes Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
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 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE BENZOYL PEROXIDE; ERYTHROMYCIN 5%;3% GEL / TOPICAL AB 2015-09-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065385-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065385-001 ERYTHROMYCIN AND BENZOYL PEROXIDE 5%;3% GEL / TOPICAL AB 2015-09-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Erythromycin and Benzoyl Peroxide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERYTHROMYCIN 50 mg/g BENZOYL PEROXIDE 30 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 63937KV33D Internal UNII lookup W9WZN9A0GM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 244374 Internal RxNorm 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 64980-328-01 Erythromycin and Benzoyl Peroxide 23.3 g in 1 JAR GEL 23.3 6 64980-328-02 Erythromycin and Benzoyl Peroxide 46.6 g in 1 JAR GEL 46.6 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-328 ERYTHROMYCIN AND BENZOYL PEROXIDE GEL [RISING PHARMA HOLDINGS, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240815_d449d7e2-5c25-406d-87ab-30809d292476.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64980-328-01 64980032801 23.3 g in 1 JAR (64980-328-01) 23.3 g 2016-10-18 0000-00-00 No No Current 64980-328-02 64980032802 46.6 g in 1 JAR (64980-328-02) 46.6 g 2016-10-18 0000-00-00 No No Current