Home NDC 21922-022 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Product NDC 21922-022
11-digit product format 219220022
Labeler code 21922
Product ID 21922-022_c3c0a548-d788-41fc-b2f8-99431a48cd05
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Dosage form GEL
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA212433
Marketing category ANDA
Marketing start 2021-05-20
Substance BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Active strength 50; 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 42 .
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 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;1.2% GEL / TOPICAL AB 2021-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212433-001 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.
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 2026-08-18 06:07:40 2026-07 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212433-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;1.2% GEL / TOPICAL AB 2021-04-28 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A212433-001 CGT 2023-03-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212433-001 CGT 2023-03-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212433-001 CGT 2023-03-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212433-001 CGT 2023-03-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212433-001 CGT 2023-03-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212433-001 CGT 2023-03-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212433-001 CGT 2023-03-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212433-001 CGT 2023-03-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212433-001 CGT 2023-03-13 f41ea6bd6efb…
Additional Listing Data#
Finished product Yes
Brand name base CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Brand name suffix 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 21922-022-06 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDECLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 1 in 1 CARTON GEL 1 2 21922-022-06 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDECLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 45 g in 1 TUBE GEL 45 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-022 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [ENCUBE ETHICALS PRIVATE LIMITED] 1 Current NDC, Legacy NDC, 2 package rows 20210520_8ca01174-431e-449a-a85e-8c68d506776c.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 · 4 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 21922-022-06 21922002206 1 TUBE in 1 CARTON (21922-022-06) / 45 g in 1 TUBE 1 tube 2021-05-20 0000-00-00 No No Current