Home NDC 68682-300 Clindamycin Phosphate 1.2% and Tretinoin 0.025%
Product NDC 68682-300
11-digit product format 686820300
Labeler code 68682
Product ID 68682-300_282973c6-50ee-441b-ab65-52bb582bf30c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate and tretinoin
Dosage form GEL
Route TOPICAL
Labeler Oceanside Pharmaceuticals
Application NDA050802
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-08-04
Substance CLINDAMYCIN PHOSPHATE; TRETINOIN
Active strength 12; .25 mg/g; mg/g
Pharmacologic classes Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [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 N050802-001 ZIANA CLINDAMYCIN PHOSPHATE; TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050802-001 AB1
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 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N050802-001 6387383 2020-08-03 U-916 Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N050802-001 6387383 2020-08-03 U-916 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050802-001 6387383 2020-08-03 U-916 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050802-001 6387383 2020-08-03 U-916 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050802-001 6387383 2020-08-03 U-916 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050802-001 6387383 2020-08-03 U-916 Drug product ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Clindamycin Phosphate 1.2% and Tretinoin 0.025%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PHOSPHATE 12 mg/g TRETINOIN .25 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 5688UTC01R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 882548 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 68682-300-30 Clindamycin Phosphate 1.2% and Tretinoin 0.025% 1 in 1 CARTON GEL 1 2 68682-300-30 Clindamycin Phosphate 1.2% and Tretinoin 0.025% 30 g in 1 TUBE GEL 30 2 68682-300-60 Clindamycin Phosphate 1.2% and Tretinoin 0.025% 1 in 1 CARTON GEL 1 2 68682-300-60 Clindamycin Phosphate 1.2% and Tretinoin 0.025% 60 g in 1 TUBE GEL 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-300 CLINDAMYCIN PHOSPHATE 1.2% AND TRETINOIN 0.025% (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [OCEANSIDE PHARMACEUTICALS] 1 Current NDC, Legacy NDC, 4 package rows 20200804_63b2e85d-8fe5-4f18-9e85-8492c49a7520.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 68682-300-30 68682030030 1 TUBE in 1 CARTON (68682-300-30) / 30 g in 1 TUBE 1 tube 2020-08-04 0000-00-00 No No Current 68682-300-60 68682030060 1 TUBE in 1 CARTON (68682-300-60) / 60 g in 1 TUBE 1 tube 2020-08-04 0000-00-00 No No Current