FDA.reportPublic FDA data

benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel

RxCUI
1598470
RxNorm name
benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel
Display name
Benzoyl peroxide/Clindamycin (Topical)
Full name
benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel
Term type
SCD
Status
Active
Strength
3.75-1.2%
Dose form
Gel
Route
Topical
Updated
2026-10-15 14:52:09

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
022015
Active start
022015
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
benzoyl peroxide0.0375 MG / 1 MGbenzoyl peroxidebenzoyl peroxide
clindamycin phosphate0.012 MG / 1 MGclindamycinclindamycin phosphate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Gel346286

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
benzoyl peroxide1418
clindamycin2582

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRbenzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel1NAMES
RxNorm Namebenzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel1NAMES
RxNorm Synonymbenzoyl peroxide 3.75 % / clindamycin phosphate 1.2 % (clindamycin 1 % ) Topical Gel1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
4 linked values
4CODES
RxCUI15984701CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
45802-383-0145802-383Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl PeroxidePadagis Israel Pharmaceuticals LtdANDA209610
51672-1403-451672-1403Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl PeroxideSun Pharmaceutical Industries, Inc.ANDA208683
68308-127-5068308-127Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl PeroxideMayne PharmaANDA209610
68682-133-5068682-133Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl PeroxideOceanside PharmaceuticalsNDA050819
72162-2419-272162-2419Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl PeroxideBryant Ranch PrepackANDA209610

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20961045802-383Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl PeroxideANDAPadagis Israel Pharmaceuticals Ltd
ANDA20868351672-1403Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl PeroxideANDASun Pharmaceutical Industries, Inc.
NDA05081968682-133Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl PeroxideNDA AUTHORIZED GENERICOceanside Pharmaceuticals

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 5 matching rows.

NDC11, Source, Active table
NDC11SourceActive
45802038301rxnav_ndcsyes
51672140304rxnav_ndcsyes
68308012750rxnav_ndcsyes
68682013350rxnav_ndcsyes
72162241902rxnav_ndcsyes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEOceanside Pharmaceuticals1d53ec2b-d33d-4245-99f1-e41b303036602025-08-15Warnings, Adverse reactionsExact identifier
ndc (package): 68682-133-50
ndc (product): 68682-133
ndc11 (package): 68682013350
rxcui: 1598470
ONEXTONCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBausch Health US, LLC697e760a-c206-4565-8f4e-a8085e2158272025-07-23Warnings, Adverse reactionsExact identifier
rxcui: 1598470
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.449884c1-cf3b-4e2c-b8a0-82442ea8523a2025-07-03Warnings, Adverse reactionsExact identifier
ndc (package): 51672-1403-4
ndc (product): 51672-1403
ndc11 (package): 51672140304
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEMayne Pharmac7381600-2e4c-4e7b-aa67-fe7d5fae7b402025-02-28Warnings, Adverse reactionsExact identifier
ndc (package): 68308-127-50
ndc (product): 68308-127
ndc11 (package): 68308012750
rxcui: 1598470
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBryant Ranch Prepackdb39492e-d964-4e59-8d65-0a2194e9a3d42024-11-11Warnings, Adverse reactionsExact identifier
ndc (package): 72162-2419-2
ndc (product): 72162-2419
ndc11 (package): 72162241902
rxcui: 1598470

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
db39492e-d964-4e59-8d65-0a2194e9a3d4clindamycin phosphate 1.2 % / benzoyl peroxide 3.75 % Topical Gel [PSN] · benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel [SCD] · benzoyl peroxide 3.75 % / clindamycin phosphate 1.2 % (clindamycin 1 % ) Topical Gel [SY]3100These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL . CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 200020241111
697e760a-c206-4565-8f4e-a8085e215827clindamycin phosphate 1.2 % / benzoyl peroxide 3.75 % Topical Gel [PSN] · benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel [SCD] · benzoyl peroxide 3.75 % / clindamycin phosphate 1.2 % (clindamycin 1 % ) Topical Gel [SY]320These 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: 200020250723
1d53ec2b-d33d-4245-99f1-e41b30303660clindamycin phosphate 1.2 % / benzoyl peroxide 3.75 % Topical Gel [PSN] · benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel [SCD] · benzoyl peroxide 3.75 % / clindamycin phosphate 1.2 % (clindamycin 1 % ) Topical Gel [SY]36These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL. CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 200020250815
c7381600-2e4c-4e7b-aa67-fe7d5fae7b40clindamycin phosphate 1.2 % / benzoyl peroxide 3.75 % Topical Gel [PSN] · benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel [SCD] · benzoyl peroxide 3.75 % / clindamycin phosphate 1.2 % (clindamycin 1 % ) Topical Gel [SY]31These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL . CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 200020250228
2dfc025a-8eac-4e05-a1fe-dc22914002bbclindamycin phosphate 1.2 % / benzoyl peroxide 3.75 % Topical Gel [PSN] · benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel [SCD] · benzoyl peroxide 3.75 % / clindamycin phosphate 1.2 % (clindamycin 1 % ) Topical Gel [SY]31These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL . CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 200020231231

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
2dfc025a-8eac-4e05-a1fe-dc22914002bbThese highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL . CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 2000Padagis Israel Pharmaceuticals Ltd20260831
1d53ec2b-d33d-4245-99f1-e41b30303660These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL. CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 2000Oceanside Pharmaceuticals | Contract Pharmaceuticals Limited Canada | Bausch Health Companies, Inc.20250815
449884c1-cf3b-4e2c-b8a0-82442ea8523aThese highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL. CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 2000Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.20250703
c7381600-2e4c-4e7b-aa67-fe7d5fae7b40These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL . CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 2000Mayne Pharma20250228
db39492e-d964-4e59-8d65-0a2194e9a3d4These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL . CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 2000Bryant Ranch Prepack20241111
2dfc025a-8eac-4e05-a1fe-dc22914002bbThese highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL . CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 2000Padagis Israel Pharmaceuticals Ltd20231231

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCG01AAAntibioticsATC1-4clindamycin
ATCD10AFAntiinfectives for treatment of acneATC1-4clindamycin
ATCJ01FFLincosamidesATC1-4clindamycin
ATCD10AEPeroxidesATC1-4benzoyl peroxide
FDASPLD055231LincosamidesCHEMhas_chemical_structureclindamycin
FDASPLN0000175443Lincosamide AntibacterialEPChas_epcclindamycin
FDASPLN0000009982Decreased Sebaceous Gland ActivityPEhas_peclindamycin
FDASPLN0000175731Neuromuscular BlockadePEhas_peclindamycin
MEDRTD001585Benzoyl PeroxideCHEMhas_ingredientbenzoyl peroxide
MEDRTD002981ClindamycinCHEMhas_ingredientclindamycin
MEDRTD002981ClindamycinCHEMhas_ingredientclindamycin phosphate
MEDRTD008034LincomycinCHEMci_chemclassclindamycin
MEDRTD008034LincomycinCHEMci_chemclassclindamycin phosphate
MEDRTD000152Acne VulgarisDISEASEmay_treatclindamycin phosphate
MEDRTD000152Acne VulgarisDISEASEmay_treatbenzoyl peroxide
MEDRTD000152Acne VulgarisDISEASEmay_treatclindamycin
MEDRTD000193Actinomycetales InfectionsDISEASEmay_treatclindamycin phosphate
MEDRTD000193Actinomycetales InfectionsDISEASEmay_treatclindamycin
MEDRTD001442Bacteroides InfectionsDISEASEmay_treatclindamycin phosphate
MEDRTD001442Bacteroides InfectionsDISEASEmay_treatclindamycin
MEDRTD004342Drug HypersensitivityDISEASEci_withclindamycin phosphate
MEDRTD004342Drug HypersensitivityDISEASEci_withbenzoyl peroxide
MEDRTD004342Drug HypersensitivityDISEASEci_withclindamycin
MEDRTD004697Endocarditis, BacterialDISEASEmay_preventclindamycin phosphate
MEDRTD004697Endocarditis, BacterialDISEASEmay_preventclindamycin
MEDRTD004761Enterocolitis, PseudomembranousDISEASEci_withclindamycin phosphate
MEDRTD004761Enterocolitis, PseudomembranousDISEASEci_withclindamycin
MEDRTD017093Liver FailureDISEASEci_withclindamycin
MEDRTD017093Liver FailureDISEASEci_withclindamycin phosphate
MEDRTD011020Pneumonia, PneumocystisDISEASEmay_treatclindamycin phosphate
MEDRTD011020Pneumonia, PneumocystisDISEASEmay_treatclindamycin
MEDRTD012393RosaceaDISEASEmay_treatbenzoyl peroxide
MEDRTD013203Staphylococcal InfectionsDISEASEmay_treatclindamycin phosphate
MEDRTD013203Staphylococcal InfectionsDISEASEmay_treatclindamycin
MEDRTD013290Streptococcal InfectionsDISEASEmay_treatclindamycin
MEDRTD013290Streptococcal InfectionsDISEASEmay_treatclindamycin phosphate
MEDRTD014123ToxoplasmosisDISEASEmay_treatclindamycin
MEDRTD014123ToxoplasmosisDISEASEmay_treatclindamycin phosphate
MEDRTD016585Vaginosis, BacterialDISEASEmay_treatclindamycin
MEDRTD016585Vaginosis, BacterialDISEASEmay_treatclindamycin phosphate
MEDRTN0000000170Free Radical Scavenging ActivityMOAhas_moabenzoyl peroxide
MEDRTN0000000150Protein Synthesis InhibitorsMOAhas_moaclindamycin
MEDRTN0000000150Protein Synthesis InhibitorsMOAhas_moaclindamycin phosphate
MEDRTN0000008841Decreased Protein SynthesisPEhas_peclindamycin
MEDRTN0000008841Decreased Protein SynthesisPEhas_peclindamycin phosphate
MEDRTN0000009982Decreased Sebaceous Gland ActivityPEhas_pebenzoyl peroxide

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.0375 MG/MG / 0.012 MG/MG (expressed as clindamycin phosphate)
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA209610
CODESVUID4033965
NAMESPrescribable Synonymclindamycin phosphate 1.2 % / benzoyl peroxide 3.75 % Topical Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File