Home NDC 0187-5205 Benzamycin
Product NDC 0187-5205
11-digit product format 001875205
Labeler code 0187
Product ID 0187-5205_4e79c358-715c-4406-8260-cb83efbc55ec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name erythromycin and benzoyl peroxide
Dosage form KIT
Labeler Bausch Health US, LLC
Application NDA050557
Marketing category NDA
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 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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 N050557-001 BENZAMYCIN 5%;3% GEL / TOPICAL AB RLD, RS 1984-10-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050557-001 BENZAMYCIN 5%;3% GEL / TOPICAL AB RLD, RS 1984-10-26 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 Benzamycin
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 213082 Internal RxNorm lookup 244374 Internal RxNorm lookup 308694 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 0187-5205-46 Benzamycin 1 in 1 BOX KIT 1 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-5205 BENZAMYCIN (ERYTHROMYCIN AND BENZOYL PEROXIDE) KIT [BAUSCH HEALTH US, LLC] 9 Current NDC, Legacy NDC, 1 package rows 20210107_c8c05e98-ec28-4636-8e5c-9a2557483e3c.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.
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 0187-5205-46 00187520546 1 KIT in 1 BOX (0187-5205-46) * 1.6 g in 1 VIAL, PLASTIC * 40 g in 1 JAR 1 kit 1984-10-26 0000-00-00 No No Current