Home NDC 45802-597 Clindamycin Phosphate and Benzoyl Peroxide
Product NDC 45802-597
11-digit product format 458020597
Labeler code 45802
Product ID 45802-597_fc3fe08e-5d69-42c0-bbdd-887ff1d944a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Phosphate, Benzoyl Peroxide
Dosage form GEL
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application ANDA205397
Marketing category ANDA
Marketing start 2019-09-12
Substance BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Active strength 25; 10 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 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205397-001 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 · 42 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 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205397-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-09-09 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 BENZOYL PEROXIDE 25 mg/g CLINDAMYCIN PHOSPHATE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W9WZN9A0GM Internal UNII lookup EH6D7113I8 Internal UNII 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 45802-597-01 Clindamycin Phosphate and Benzoyl Peroxide 1 in 1 CARTON GEL 1 7 45802-597-01 Clindamycin Phosphate and Benzoyl Peroxide 50 g in 1 BOTTLE, PUMP GEL 50 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-597 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN PHOSPHATE, BENZOYL PEROXIDE) GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD] 7 Current NDC, Legacy NDC, 2 package rows 20231013_221de6a3-c1d7-4dcf-a47b-51edaa682c2a.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 45802-597-01 45802059701 1 BOTTLE, PUMP in 1 CARTON (45802-597-01) / 50 g in 1 BOTTLE, PUMP 2019-09-12 0000-00-00 No No Current