Home NDC 0187-0006 Cabtreo
Product NDC 0187-0006
11-digit product format 001870006
Labeler code 0187
Product ID 0187-0006_338bc721-434d-cbc2-e063-6394a90abc47
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate/benzoyl peroxide/adapalene
Dosage form GEL
Route TOPICAL
Labeler Bausch Health US LLC
Application NDA216632
Marketing category NDA
Marketing start 2023-10-20
Substance ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Active strength 1.5; 31; 12 mg/g; 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 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 N216632-001 CABTREO ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216632-001 10220049 2029-06-03 U-3713 Drug product 2023-11-02 N216632-001 10624918 2029-06-03 U-3713 2023-11-02 N216632-001 9561208 2029-06-03 U-3713 Drug product 2023-11-02 N216632-001 8288434 2029-08-05 U-3713 Drug product 2023-11-02 N216632-001 12128059 2040-07-31 U-3713 Drug product 2024-11-08 N216632-001 12133859 2040-07-31 Drug product 2024-11-22 N216632-001 12138278 2040-07-31 Drug product 2024-12-06 N216632-001 12616710 2040-07-31 Drug product 2026-05-21 N216632-001 11389467 2040-12-28 U-3713 Drug product 2023-11-02
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216632-001 NP 2026-10-20
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 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216632-001 CABTREO 0.15%;3.1%;1.2% GEL / TOPICAL RLD, RS 2023-10-20 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N216632-001 10220049 2029-06-03 U-3713 Drug product 2023-11-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216632-001 10624918 2029-06-03 U-3713 2023-11-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216632-001 9561208 2029-06-03 U-3713 Drug product 2023-11-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216632-001 8288434 2029-08-05 U-3713 Drug product 2023-11-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216632-001 12128059 2040-07-31 U-3713 Drug product 2024-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216632-001 12133859 2040-07-31 Drug product 2024-11-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216632-001 12138278 2040-07-31 Drug product 2024-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216632-001 12616710 2040-07-31 Drug product 2026-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216632-001 11389467 2040-12-28 U-3713 Drug product 2023-11-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216632-001 10220049 2029-06-03 U-3713 Drug product 2023-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216632-001 10624918 2029-06-03 U-3713 2023-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216632-001 9561208 2029-06-03 U-3713 Drug product 2023-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216632-001 8288434 2029-08-05 U-3713 Drug product 2023-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216632-001 12128059 2040-07-31 U-3713 Drug product 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216632-001 12133859 2040-07-31 Drug product 2024-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216632-001 12138278 2040-07-31 Drug product 2024-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216632-001 11389467 2040-12-28 U-3713 Drug product 2023-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216632-001 10220049 2029-06-03 U-3713 Drug product 2023-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216632-001 10624918 2029-06-03 U-3713 2023-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216632-001 9561208 2029-06-03 U-3713 Drug product 2023-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216632-001 8288434 2029-08-05 U-3713 Drug product 2023-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216632-001 12128059 2040-07-31 U-3713 Drug product 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216632-001 12133859 2040-07-31 Drug product 2024-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216632-001 12138278 2040-07-31 Drug product 2024-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216632-001 11389467 2040-12-28 U-3713 Drug product 2023-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216632-001 10220049 2029-06-03 U-3713 Drug product 2023-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216632-001 10624918 2029-06-03 U-3713 2023-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216632-001 9561208 2029-06-03 U-3713 Drug product 2023-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216632-001 8288434 2029-08-05 U-3713 Drug product 2023-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216632-001 12128059 2040-07-31 U-3713 Drug product 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216632-001 12133859 2040-07-31 Drug product 2024-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216632-001 12138278 2040-07-31 Drug product 2024-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216632-001 11389467 2040-12-28 U-3713 Drug product 2023-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216632-001 10220049 2029-06-03 U-3713 Drug product 2023-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216632-001 10624918 2029-06-03 U-3713 2023-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216632-001 9561208 2029-06-03 U-3713 Drug product 2023-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216632-001 8288434 2029-08-05 U-3713 Drug product 2023-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216632-001 12128059 2040-07-31 U-3713 Drug product 2024-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216632-001 12133859 2040-07-31 Drug product 2024-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216632-001 12138278 2040-07-31 Drug product 2024-12-06 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Cabtreo
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PHOSPHATE 1.5 mg/g BENZOYL PEROXIDE 31 mg/g ADAPALENE 12 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EH6D7113I8 Internal UNII lookup W9WZN9A0GM Internal UNII lookup 1L4806J2QF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2668198 Internal RxNorm lookup 2668204 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-0006 CABTREO (CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE) GEL [BAUSCH HEALTH US LLC] 6 Current NDC, 5 package rows 20250426_9468da0f-9978-4c58-8135-0274c3415084.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cabtreo CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE Bausch Health US LLC 9468da0f-9978-4c58-8135-0274c3415084 2025-04-24 Warnings, Adverse reactions Exact identifier application applno (NDA): 216632 application number: NDA216632 ndc (product): 0187-0006
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0187-0006-10 00187000610 1 BOTTLE, PUMP in 1 CARTON (0187-0006-10) / 20 g in 1 BOTTLE, PUMP 2023-10-20 No No Current 0187-0006-25 00187000625 1 BOTTLE, PUMP in 1 CARTON (0187-0006-25) / 50 g in 1 BOTTLE, PUMP 2023-10-20 No No Current 0187-0006-35 00187000635 3.5 g in 1 TUBE (0187-0006-35) 3.5 g 2023-10-20 Yes No Current