Home RxNorm 1598826 benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel [Onexton] Drug identity information. FDA.report links public drug records from RxNav, DailyMed, FDA NDC, Drugs@FDA, and related public sources where available. This page is informational only and is not medical, prescribing, or regulatory advice.
RxCUI 1598826
RxNorm name benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel [Onexton]
Display name ONEXTON (Topical)
Full name benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel [Onexton]
Term type SBD
Status Active
Strength 3.75-1.2%
Dose form Gel
Route Topical
Updated 2026-10-15 14:52:18 RxNorm Status History#
Status Active
Source RXNORM
Current YES
Release start 022015
Active start 022015
Multiple ingredient YES
Branded YES Ingredients And Strength# Ingredient, Strength, Base table Ingredient Strength Base Basis of strength benzoyl peroxide 0.0375 MG / 1 MG benzoyl peroxide benzoyl peroxide clindamycin phosphate 0.012 MG / 1 MG clindamycin clindamycin phosphate
Derived Ingredient Concepts# FDA NDC Products And Packages# Package NDC, Product NDC, Name table Package NDC Product NDC Name Labeler Application 0187-3050-35 0187-3050 ONEXTON Clindamycin Phosphate and Benzoyl Peroxide Bausch Health US, LLC NDA050819 0187-3050-50 0187-3050 ONEXTON Clindamycin Phosphate and Benzoyl Peroxide Bausch Health US, LLC NDA050819
Drugs@FDA Applications# Application, NDC, Name table Application NDC Name Marketing category Labeler NDA050819 0187-3050 ONEXTON Clindamycin Phosphate and Benzoyl Peroxide NDA Bausch Health US, LLC
RxNav Current And Historical NDCs# RxNav current and historical NDC rows page 1 of 1 · 2 matching rows.
NDC11, Source, Active table NDC11 Source Active 00187305035 rxnav_ndcs yes 00187305050 rxnav_ndcs yes
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Set ID, RxNorm mappings, Terms table Set ID RxNorm mappings Terms SPL version Label Effective 697e760a-c206-4565-8f4e-a8085e215827 ONEXTON 1.2 % / 3.75 % Topical Gel [PSN] · benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel [Onexton] [SBD] · Onexton (benzoyl peroxide 3.75 % / clindamycin phosphate 1.2 % (clindamycin 1 % )) Topical Gel [SY] · Onexton (benzoyl peroxide 3.75 % / clindamycin phosphate 1.2 % ) Topical Gel [SY] 4 20 These highlights do not include all the information needed to use ONEXTON Gel safely and effectively. See full prescribing information for ONEXTON Gel. ONEXTON® (clindamycin phosphate and benzoyl peroxide) gel, 1.2%/3.75% for topical use Initial U.S. Approval: 2000 20250723
Recently Linked DailyMed Labels# Set ID, Title, Manufacturer table Set ID Title Manufacturer Effective 697e760a-c206-4565-8f4e-a8085e215827 These highlights do not include all the information needed to use ONEXTON Gel safely and effectively. See full prescribing information for ONEXTON Gel. ONEXTON® (clindamycin phosphate and benzoyl peroxide) gel, 1.2%/3.75% for topical use Initial U.S. Approval: 2000 Bausch Health US, LLC | Contract Pharmaceuticals Limited Canada | Bausch Health Companies, Inc. 20250723 697e760a-c206-4565-8f4e-a8085e215827 These highlights do not include all the information needed to use ONEXTON Gel safely and effectively. See full prescribing information for ONEXTON Gel. ONEXTON® (clindamycin phosphate and benzoyl peroxide) gel, 1.2%/3.75% for topical use Initial U.S. Approval: 2000 Bausch Health US, LLC | Contract Pharmaceuticals Limited Canada | Bausch Health Companies, Inc. 20250723
Drug Classes# Source, Class ID, Class table Source Class ID Class Type Relationship Drug concept ATC G01AA Antibiotics ATC1-4 clindamycin ATC D10AF Antiinfectives for treatment of acne ATC1-4 clindamycin ATC J01FF Lincosamides ATC1-4 clindamycin ATC D10AE Peroxides ATC1-4 benzoyl peroxide FDASPL D055231 Lincosamides CHEM has_chemical_structure clindamycin FDASPL N0000175443 Lincosamide Antibacterial EPC has_epc clindamycin FDASPL N0000009982 Decreased Sebaceous Gland Activity PE has_pe clindamycin FDASPL N0000175731 Neuromuscular Blockade PE has_pe clindamycin MEDRT D001585 Benzoyl Peroxide CHEM has_ingredient benzoyl peroxide MEDRT D002981 Clindamycin CHEM has_ingredient clindamycin MEDRT D002981 Clindamycin CHEM has_ingredient clindamycin phosphate MEDRT D008034 Lincomycin CHEM ci_chemclass clindamycin MEDRT D008034 Lincomycin CHEM ci_chemclass clindamycin phosphate MEDRT D000152 Acne Vulgaris DISEASE may_treat clindamycin phosphate MEDRT D000152 Acne Vulgaris DISEASE may_treat benzoyl peroxide MEDRT D000152 Acne Vulgaris DISEASE may_treat clindamycin MEDRT D000193 Actinomycetales Infections DISEASE may_treat clindamycin phosphate MEDRT D000193 Actinomycetales Infections DISEASE may_treat clindamycin MEDRT D001442 Bacteroides Infections DISEASE may_treat clindamycin phosphate MEDRT D001442 Bacteroides Infections DISEASE may_treat clindamycin MEDRT D004342 Drug Hypersensitivity DISEASE ci_with clindamycin phosphate MEDRT D004342 Drug Hypersensitivity DISEASE ci_with benzoyl peroxide MEDRT D004342 Drug Hypersensitivity DISEASE ci_with clindamycin MEDRT D004697 Endocarditis, Bacterial DISEASE may_prevent clindamycin phosphate MEDRT D004697 Endocarditis, Bacterial DISEASE may_prevent clindamycin MEDRT D004761 Enterocolitis, Pseudomembranous DISEASE ci_with clindamycin phosphate MEDRT D004761 Enterocolitis, Pseudomembranous DISEASE ci_with clindamycin MEDRT D017093 Liver Failure DISEASE ci_with clindamycin MEDRT D017093 Liver Failure DISEASE ci_with clindamycin phosphate MEDRT D011020 Pneumonia, Pneumocystis DISEASE may_treat clindamycin phosphate MEDRT D011020 Pneumonia, Pneumocystis DISEASE may_treat clindamycin MEDRT D012393 Rosacea DISEASE may_treat benzoyl peroxide MEDRT D013203 Staphylococcal Infections DISEASE may_treat clindamycin phosphate MEDRT D013203 Staphylococcal Infections DISEASE may_treat clindamycin MEDRT D013290 Streptococcal Infections DISEASE may_treat clindamycin MEDRT D013290 Streptococcal Infections DISEASE may_treat clindamycin phosphate MEDRT D014123 Toxoplasmosis DISEASE may_treat clindamycin MEDRT D014123 Toxoplasmosis DISEASE may_treat clindamycin phosphate MEDRT D016585 Vaginosis, Bacterial DISEASE may_treat clindamycin MEDRT D016585 Vaginosis, Bacterial DISEASE may_treat clindamycin phosphate MEDRT N0000000170 Free Radical Scavenging Activity MOA has_moa benzoyl peroxide MEDRT N0000000150 Protein Synthesis Inhibitors MOA has_moa clindamycin MEDRT N0000000150 Protein Synthesis Inhibitors MOA has_moa clindamycin phosphate MEDRT N0000008841 Decreased Protein Synthesis PE has_pe clindamycin MEDRT N0000008841 Decreased Protein Synthesis PE has_pe clindamycin phosphate MEDRT N0000009982 Decreased Sebaceous Gland Activity PE has_pe benzoyl peroxide
Properties# Category, Property, Value table Category Property Value ATTRIBUTES AVAILABLE_STRENGTH 0.0375 MG/MG / 0.012 MG/MG (expressed as clindamycin phosphate) ATTRIBUTES GENERAL_CARDINALITY MULTI ATTRIBUTES HUMAN_DRUG US ATTRIBUTES RXNAV_HUMAN_DRUG US ATTRIBUTES SCHEDULE 0 CODES NDA NDA050819 NAMES Prescribable Synonym ONEXTON 1.2 % / 3.75 % Topical Gel SOURCES Source Gold Standard Alchemy SOURCES Source Metathesaurus FDA Structured Product Labels SOURCES Source Micromedex RED BOOK SOURCES Source Multum MediSource Lexicon