Home NDC 45802-736 clindamycin phosphate and benzoyl peroxide
Product NDC 45802-736
11-digit product format 458020736
Labeler code 45802
Product ID 45802-736_4934962f-c507-4b32-9196-dded1e01eed1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin, Benzoyl Peroxide
Dosage form GEL
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application ANDA090979
Marketing category ANDA
Marketing start 2012-06-26
Substance CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE
Active strength 10; 50 mg/g; mg/g
Pharmacologic classes Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
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 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090979-001 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 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2012-06-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2012-06-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2012-06-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2012-06-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2012-06-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2012-06-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090979-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB RS 2012-06-26 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 clindamycin phosphate and benzoyl peroxide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PHOSPHATE 10 mg/g BENZOYL PEROXIDE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EH6D7113I8 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 1540241 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 45802-736-84 clindamycin phosphate and benzoyl peroxide 1 in 1 CARTON GEL 1 8 45802-736-84 clindamycin phosphate and benzoyl peroxide 45 g in 1 TUBE GEL 45 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZOYL PEROXIDE ACTIVE INGREDIENT W9WZN9A0GM CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE) GEL [PERRIGO NEW YORK INC] 4 CLINDAMYCIN PHOSPHATE ACTIVE INGREDIENT EH6D7113I8 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE) GEL [PERRIGO NEW YORK INC] 4 BENZOYL PEROXIDE ACTIVE MOIETY W9WZN9A0GM CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE) GEL [PERRIGO NEW YORK INC] 4 CLINDAMYCIN ACTIVE MOIETY 3U02EL437C CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE) GEL [PERRIGO NEW YORK INC] 4 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT HHT01ZNK31 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE) GEL [PERRIGO NEW YORK INC] 4 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE) GEL [PERRIGO NEW YORK INC] 4 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE) GEL [PERRIGO NEW YORK INC] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE) GEL [PERRIGO NEW YORK INC] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE) GEL [PERRIGO NEW YORK INC] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE) GEL [PERRIGO NEW YORK INC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE) GEL [PERRIGO NEW YORK INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-736 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE) GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD] 8 Current NDC, Legacy NDC, 2 package rows 20230729_1c7040f2-e503-408a-b07e-72c7972ce78d.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 45802-736-84 45802073684 1 TUBE in 1 CARTON (45802-736-84) / 45 g in 1 TUBE 1 tube 2012-06-26 0000-00-00 No No Current