FDA.reportPublic FDA data

NDC 45802-998 - clindamycin and benzoyl peroxide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
45802-998
Package NDCs from labels
45802-998-03
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Effective date
2022-03-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
clindamycin and benzoyl peroxide - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2022-03-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-998-03clindamycin and benzoyl peroxide27.6 g in 1 BOTTLE, PUMPGEL27.6 g50 mg in 1g4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-998CLINDAMYCIN AND BENZOYL PEROXIDE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD]4Unmatched20231011_6bf0f3e5-6ad7-4791-9483-0977b18ad77f.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 40 of 43 · 844 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE, BENZOYL PEROXIDEBryant Ranch Prepackac7f5c47-a06a-495f-a914-13c930106c8d2023-07-17Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
unii: EH6D7113I8
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cleocin PhosphateCLINDAMYCIN PHOSPHATEMedical Purchasing Solutions, LLC896a046f-95d0-100e-e053-2a95a90aa59c2023-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
ClindamycinCLINDAMYCIN PHOSPHATEMedical Purchasing Solutions, LLC9e500a08-0339-eb6b-e053-2a95a90a130c2023-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
ClindamycinCLINDAMYCIN PHOSPHATEMedical Purchasing Solutions, LLC9e4fc2d5-985a-3734-e053-2995a90aef5b2023-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Cleocin PhosphateCLINDAMYCIN PHOSPHATEMedical Purchasing Solutions, LLC9e549ceb-00e8-64b8-e053-2a95a90aef0f2023-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
ClindamycinCLINDAMYCIN PHOSPHATEMedical Purchasing Solutions, LLC9e545c9d-dc39-584c-e053-2995a90afda42023-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Cleocin PhosphateCLINDAMYCIN PHOSPHATEMedical Purchasing Solutions, LLC9e5365a0-dd47-264a-e053-2a95a90a7fb82023-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ClindamycinCLINDAMYCIN PHOSPHATEMedical Purchasing Solutions, LLCdc8b8a09-3eed-1998-e053-2995a90a2f602023-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Clindamycin Phosphate and TretinoinCLINDAMYCIN PHOSPHATE AND TRETINOINActavis Pharma, Inc.79e1c8f6-59cd-4efa-9efa-0762d4b1a10c2023-02-27Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltde50e3ef9-3a9b-4172-a908-71c973a7fb5c2023-02-01Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEPadagis Israel Pharmaceuticals Ltd6f72b852-e741-48e5-b8e1-f8a1afcfb4d42023-02-01Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
ClindacinCLINDAMYCIN PHOSPHATEMedimetriks Pharmaceuticals, Inc.d01ffda3-1913-400d-a899-58b8face89362022-11-21Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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